{"analyses":[{"ciLowerLimit":"0.648","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.964","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 second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O'Brien-Fleming-type α spending function based on the actual number of events (α=0.0123).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0100","pValueComment":"The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.","paramType":"Hazard Ratio (HR)","paramValue":"0.791","statisticalComment":"Log rank test stratified by the randomization stratification factors.","statisticalMethod":"Stratified Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"32.6","upperLimit":"42.3","value":"40.0"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG001","lowerLimit":"42.5","upperLimit":"NA","value":"47.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"465"},{"groupId":"OG001","value":"464"}],"units":"Participants"}],"description":"Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive).\n\nMedian overall survival was estimated using the Kaplan-Meier method.","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 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"months"}