{"analyses":[{"groupDescription":"Statistical analysis for comparison of Overall Response between the Kd and IKd arms based on primary analysis.","groupIds":["OG000","OG001"],"nonInferiorityComment":"A closed test procedure was used to control the Type I error rate from the primary efficacy endpoints sequentially through the secondary efficacy endpoints. No further testing would be performed unless the significance level had been reached on PFS and testing on subsequent endpoints were continued only if the null hypothesis for the previously tested endpoint was rejected.","nonInferiorityType":"SUPERIORITY","pValue":"0.1930","pValueComment":"One-sided p-value based on Stratified Cochran-Mantel-Haenszel test. Threshold for statistical significance level at 0.025.","statisticalComment":"One sided p-value was stratified based on randomization factors according to IRT.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"82.9"},{"groupId":"OG001","value":"86.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"description":"OR: participants with sCR, CR, VGPR \\& partial response (PR) as best overall response assessed by IRC using IMWG response criteria (from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/cutoff date, whichever occurs 1st). sCR: negative immunofixation on serum \\& urine, disappearance of soft tissue plasmacytoma, \\<5% plasma cells in bone marrow aspirate (BMA) + normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. CR: negative immunofixation on serum \\& urine, disappearance of soft tissue plasmacytoma, \\<5% plasma cells in BMA. VGPR: serum \\& urine M-protein detectable by immunofixation, not on electrophoresis/,\\>=90% reduction in serum M-protein + urine M-protein level \\<100mg/24h/,\\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR:\\>=50% reduction of serum M-protein \\& decrease in 24h urinary M-protein by \\>=90%/\\<200mg/24h, if present at baseline,\\>=50% decrease in SPD of soft tissue plasmacytoma.","groups":[{"description":"Participants received carfilzomib 20 mg/m\\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).","id":"OG000","title":"Carfilzomib + Dexamethasone (Kd)"},{"description":"Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).","id":"OG001","title":"Isatuximab + Carfilzomib + Dexamethasone (IKd)"}],"paramType":"NUMBER","populationDescription":"Analysis was performed on ITT population.","reportingStatus":"POSTED","timeFrame":"From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)","title":"Percentage of Participants With Overall Response (OR) as Determined by Independent Response Committee: Primary Analysis","type":"SECONDARY","unitOfMeasure":"percentage of participants"}