{"analyses":[{"ciLowerLimit":"0.437","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.651","estimateComment":"The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.","groupDescription":"The PFS interim analysis was to be performed using a group sequential monitoring plan.\n\nThe monitoring plan included an O'Brien-Fleming type of efficacy stopping boundary constructed using the Lan-DeMets alpha spending function to ensure a 1-sided Type I error rate ≤ 0.025.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"< 0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.533","statisticalComment":"Log rank test stratified by the randomization stratification factors.","statisticalMethod":"Stratified Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.4","upperLimit":"10.4","value":"9.4"},{"comment":"Could not be estimated due to the low number of events.","groupId":"OG001","lowerLimit":"15.6","upperLimit":"NA","value":"18.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"465"},{"groupId":"OG001","value":"464"}],"units":"Participants"}],"description":"Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).\n\nMedian PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.","id":"OG000","title":"Bortezomib + DEX"},{"description":"Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.","id":"OG001","title":"Carfilzomib + DEX"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively","title":"Progression-free Survival","type":"PRIMARY","unitOfMeasure":"months"}