{"analyses":[{"ciLowerLimit":"1.23","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.91","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","paramType":"Hazard Ratio (HR)","paramValue":"1.53","statisticalComment":"Observed Stratified Log Rank Test (1-sided p-value)","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"38.1","upperLimit":"53.7","value":"46.2"},{"comment":"95% CI upper bound not estimable because data not mature enough. Specifically, with the follow-up observed as of data extraction, there were not enough events.","groupId":"OG001","lowerLimit":"58.6","upperLimit":"NA","value":"67.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"365"}],"units":"Participants"}],"description":"PFS was estimated using the Kaplan-Meier (KM) method and defined as time from randomization to the earlier of disease progression (PD) as determined by central review or death from any cause (events). Patients who started non-protocol therapy (NPT) were censored at the date of NPT initiation if available or date treatment ended if date of NPT was missing. Deaths occurring beyond 1 year from the date last known progression-free are not counted as events and censored at date of last disease evaluation. Patients who had not started NPT, progressed, or died were censored at the date of last disease evaluation. PD was based upon the International Myeloma Working Group (IMWG) uniform response criteria. \\[Kumar S, et al Lancet Oncol 2016;17(8):e328-e346\\].","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":"MEDIAN","populationDescription":"The analysis population is comprised of all randomized participants.","reportingStatus":"POSTED","timeFrame":"On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median (maximum) PFS follow-up was 70 and 129 months.","title":"Median Progression-Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}