{"analyses":[{"ciLowerLimit":"0.595","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.033","estimateComment":"KdD/Kd","groupDescription":"Hazard ratio and corresponding 95% CIs were estimated using the stratified Cox proportional hazards models.\n\n1-sided p-value from the log-rank test controlling for the randomization stratification factors.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0417","paramType":"Cox Proportional Hazard","paramValue":"0.784","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Not enough events to estimate the upper 95% CI","groupId":"OG000","lowerLimit":"35.3","upperLimit":"NA","value":"43.6"},{"comment":"Not enough events to estimate the upper 95% CI","groupId":"OG001","lowerLimit":"44.7","upperLimit":"NA","value":"50.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"description":"Overall survival was defined as the time from randomization until death from any cause. Deaths collected via public source, after end of study were included. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive were censored at the date last known to be alive.","dispersionType":"95% Confidence Interval","groups":[{"description":"Carfilzomib was administered intravenously (IV) at 20 mg/m\\^2 in Cycle 1: days 1 and 2; at 56 mg/m\\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.\n\nDexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.","id":"OG000","title":"Kd - Carfilzomib and Dexamethasone"},{"description":"Carfilzomib was administered intravenously (IV) at 20 mg/m\\^2 in Cycle 1: days 1 and 2; at 56 mg/m\\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.\n\nDexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.\n\nDaratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.","id":"OG001","title":"KdD - Carfilzomib, Dexamethasone and Daratumumab"}],"paramType":"MEDIAN","populationDescription":"Intent to Treat Population","reportingStatus":"POSTED","timeFrame":"Up to 58 months after the first participant was enrolled (at FA DCO, a median of 40.29 weeks of treatment [any study drug] in the Kd group and 79.29 weeks of treatment [any study drug] in the KdD group; FA DCO was 15 Apr 2022)","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"months"}