{"analyses":[{"ciLowerLimit":"1.184","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.129","estimateComment":"KdD/Kd","groupDescription":"Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.\n\nP-values were calculated using the stratified Cochran-Mantel-Haenszel Chi-Square test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0040","paramType":"Odds Ratio (OR)","paramValue":"1.925","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"67.0","upperLimit":"81.3","value":"74.7"},{"groupId":"OG001","lowerLimit":"79.8","upperLimit":"88.1","value":"84.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"description":"Overall response rate was defined as the percentage of participants in each treatment group who achieve partial response (PR) or better per the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) as their best response.\n\nComplete Response (CR): No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow.\n\nVery Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-component with urine M-component \\<100 mg/24 hours.\n\nPartial Response (PR): ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to \\< 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.\n\n95% CIs for proportions were estimated using the Clopper-Pearson method.","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":"NUMBER","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":"Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}