{"analyses":[{"ciLowerLimit":"1.519","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.718","estimateComment":"The odds ratio (carfilzomib/bortezomib) was calculated using the Cochran-Mantel-Haenszel method stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"< 0.0001","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":"Odds Ratio (OR)","paramValue":"2.032","statisticalComment":"Cochran-Mantel-Haenszel test stratified by the randomization stratification factors.","statisticalMethod":"Stratified Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"58.0","upperLimit":"67.0","value":"62.6"},{"groupId":"OG001","lowerLimit":"72.8","upperLimit":"80.7","value":"76.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"465"},{"groupId":"OG001","value":"464"}],"units":"Participants"}],"description":"Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).\n\nsCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).\n\nCR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein \\<100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.\n\nPR: ≥ 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.","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":"NUMBER","populationDescription":"Intent-to-treat population","reportingStatus":"POSTED","timeFrame":"Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.","title":"Overall Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}