{"analyses":[{"ciLowerLimit":"1.010","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.973","estimateComment":"Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0218","pValueComment":"Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.","paramType":"Odds Ratio (OR)","paramValue":"1.412","statisticalComment":"Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.","statisticalMethod":"Stratified Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"74.9","upperLimit":"82.4","value":"78.8"},{"groupId":"OG001","lowerLimit":"80.7","upperLimit":"87.5","value":"84.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"478"}],"units":"Participants"}],"description":"Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response 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).\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 in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG000","title":"Bortezomib, Melphalan, Prednisone"},{"description":"Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG001","title":"Carfilzomib, Melphalan, Prednisone"}],"paramType":"NUMBER","populationDescription":"Intent-to-treat population","reportingStatus":"POSTED","timeFrame":"Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.","title":"Overall Response Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}