{"analyses":[{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.77","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.61","statisticalMethod":"Based on Cox proportional hazards model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.66","upperLimit":"13.73","value":"11.20"},{"groupId":"OG001","lowerLimit":"5.88","upperLimit":"8.48","value":"7.10"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"278"}],"units":"Participants"}],"description":"Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death.\n\nProgressive Disease is defined as an Increase of ≥ 25% from nadir in:\n\n* Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g\n* Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours)\n* In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be \\> 100 mg/dL.\n* Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h\n* Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium \\> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.","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 progressive disease or death during the IRAC assessment period, up to approximately 42 months","title":"Progression Free Survival by Independent Response Adjudication Committee (IRAC)","type":"PRIMARY","unitOfMeasure":"Months"}