{"analyses":[{"ciLowerLimit":"0.746","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.101","estimateComment":"The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.","groupDescription":"The inferential test associated with the primary analysis of PFS was assessed against an overall 1-sided significance level of α=0.025.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1590","pValueComment":"The p-value boundary for PFS analysis was 0.02141.","paramType":"Hazard Ratio (HR)","paramValue":"0.906","statisticalComment":"Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"20.8","upperLimit":"24.4","value":"22.1"},{"groupId":"OG001","lowerLimit":"20.9","upperLimit":"26.7","value":"22.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"478"}],"units":"Participants"}],"description":"Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression.\n\nParticipants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG000","title":"Bortezomib, Melphalan, Prednisone"},{"description":"Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG001","title":"Carfilzomib, Melphalan, Prednisone"}],"paramType":"MEDIAN","populationDescription":"The intent-to-treat population included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.","title":"Progression-Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}