{"analyses":[{"ciLowerLimit":"0.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.02","estimateComment":"Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.064","paramType":"Hazard Ratio (HR)","paramValue":"0.76","statisticalComment":"The p-value is based on an unstratified log-rank test.","statisticalMethod":"Unstratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.94","upperLimit":"18.10","value":"13.70"},{"groupId":"OG001","lowerLimit":"8.11","upperLimit":"14.78","value":"10.94"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"139"}],"units":"Participants"}],"description":"Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first.\n\nComplete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow\n\nSCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence\n\nVGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \\< 100 mg per 24 hours\n\nPR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \\< 200 mg per 24 hours\n\nProgressive Disease: Please refer to Primary outcome measure for definition\n\nSD: Not meeting criteria for CR, VGPR, PR, or progressive disease","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 with a response (sCR or CR or VGPR or PR)","reportingStatus":"POSTED","timeFrame":"From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months","title":"Duration of Response by Independent Response Adjudication Committee (IRAC)","type":"SECONDARY","unitOfMeasure":"Months"}