{"analyses":[{"ciLowerLimit":"0.77","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.15","estimateComment":"Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.571","paramType":"Hazard Ratio (HR)","paramValue":"0.94","statisticalComment":"The p-value is based on a stratified log-rank test with stratification factors as above Cox model.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.55","upperLimit":"41.20","value":"35.58"},{"groupId":"OG001","lowerLimit":"26.05","upperLimit":"37.16","value":"31.61"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"278"}],"units":"Participants"}],"description":"Overall survival (OS) is calculated as the time from randomization to death from any cause.","dispersionType":"95% Confidence Interval","groups":[{"description":"POM (Pomalidomide)\n\n* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)\n* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle\n* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)\n* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.\n* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.","id":"OG000","title":"Treatment 1: POM+BTZ+LD-DEX"},{"description":"BTZ ((Bortezomib)\n\n* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle\n* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)\n* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.\n* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.","id":"OG001","title":"Treatment 2: BTZ+LD-DEX"}],"paramType":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization to date of death, up to approximately 65 months","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Months"}