{"analyses":[{"ciLowerLimit":"0.464","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.854","estimateComment":"KdD/Kd","groupDescription":"Stratification factors used in the Log-rank p-value (1-sided) and the Cox model hazard ratio (KdD/Kd) were as assessed at randomization: International Staging System stage at screening (Stage 1 or 2 vs Stage 3); prior proteasome inhibitor exposure (yes vs no); number of prior lines of therapy (1 vs \\>= 2).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0014","pValueComment":"alpha level of 0.025","paramType":"Stratified Cox model hazard ratio","paramValue":"0.630","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"110"}],"title":"Participants with PFS events"},{"measurements":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"202"}],"title":"Participants who were censored"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"312"}],"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). The duration of PFS was right censored for participants who met any of the following conditions: 1. no baseline/post-baseline disease assessments; 2. started a new anti myeloma therapy before documentation of progressive disease or death; 3. progressive disease or death immediately after more than 70 days without disease assessment visit or; 4. alive without documentation of disease progression before the analysis trigger date (PA DCO); 5. lost to follow-up or withdrawn consent.","groups":[{"description":"Carfilzomib was administered intravenously (IV) at 20 mg/m\\^2 in Cycle 1: days 1 and 2; at 56 mg/m\\^2 in Cycle 1: days 8,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":"COUNT_OF_PARTICIPANTS","populationDescription":"Intent to Treat Population","reportingStatus":"POSTED","timeFrame":"From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks","title":"Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only)","type":"PRIMARY","unitOfMeasure":"Participants"}