{"analyses":[{"ciLowerLimit":"1.716","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.598","estimateComment":"Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method stratified by the randomization stratification factors.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","pValueComment":"Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.","paramType":"Odds Ratio (OR)","paramValue":"2.485","statisticalComment":"One-sided p-value from CMH test stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"1.707","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.563","estimateComment":"Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"2.466","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"34.5","upperLimit":"47.3","value":"40.8"},{"groupId":"OG001","lowerLimit":"56.5","upperLimit":"69.0","value":"62.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"240"}],"units":"Participants"}],"description":"Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response rate 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 carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).\n\nParticipants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG000","title":"Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone"},{"description":"Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).\n\nParticipants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG001","title":"Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Intent-to-treat population","reportingStatus":"POSTED","timeFrame":"Disease response was assessed every 28 days until progressive disease, up to the data cut-off date of 15 June 2017; median time on follow-up was 12.0 and 12.6 months in each treatment group respectively.","title":"Overall Response Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}