{"analyses":[{"ciLowerLimit":"0.73","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.65","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":">0.99","paramType":"Hazard Ratio (HR)","paramValue":"1.10","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"74.3","upperLimit":"83.3","value":"79.2"},{"groupId":"OG001","lowerLimit":"76.1","upperLimit":"84.6","value":"80.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"365"}],"units":"Participants"}],"description":"OS was estimated using the KM method and defined as time from randomization to death due to any cause. Patients alive were censored at date last known alive. The 5-year OS endpoint is a probability.","dispersionType":"95% Confidence Interval","groups":[{"description":"All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"OG000","title":"RVD Alone"},{"description":"All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study.\n\nAfter finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"OG001","title":"RVD Plus ASCT"}],"paramType":"NUMBER","populationDescription":"The analysis population is comprised of all randomized participants.","reportingStatus":"POSTED","timeFrame":"In long-term follow-up, survival follow-up every 2 months until death. Median (maximum) OS follow-up was 76 and 129 months.The probability estimate is at 5 years.","title":"5-Year Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"percent probability"}