{"analyses":[{"ciLowerLimit":"0.882","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.032","estimateComment":"Risk ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The non-inferiority margin was 0.87 for the estimated ORR risk ratio.","nonInferiorityType":"NON_INFERIORITY","pValue":"0.0666","pValueComment":"P-value (2.5% significance level) of the non-inferiority test via the synthesis approach (FDA, 2016) for non-inferiority comparison of ORR between treatment arms.","paramType":"Risk Ratio (RR)","paramValue":"0.954","statisticalMethod":"Synthesis approach"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"81.1","upperLimit":"90.5","value":"86.3"},{"groupId":"OG001","lowerLimit":"76.9","upperLimit":"87.2","value":"82.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"228"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \\< 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \\< 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to \\< 200 mg/24-hours. The ORR 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.","id":"OG000","title":"Twice-weekly KRd 20/27 mg/m^2"},{"description":"Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\\^2 on Day 1 of Cycle 1 and 56 mg/m\\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.","id":"OG001","title":"Once-weekly KRd 20/56 mg/m^2"}],"paramType":"NUMBER","populationDescription":"The intent-to-treat (ITT) population included all randomized participants.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.","title":"Overall Response Rate (ORR) Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}