{"analyses":[{"ciLowerLimit":"0.888","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.471","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"Stratification was done on the number of prior lines of therapy (1 vs. \\>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.","paramType":"Stratified Hazard Ratio","paramValue":"1.143"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.051","upperLimit":"1.183","value":"1.12"},{"groupId":"OG001","lowerLimit":"1.051","upperLimit":"1.117","value":"1.08"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"description":"Time to first response was defined as the time (in months) from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. In the absence of response, participants were censored at the earliest of the date of the last valid disease assessment before disease progression or death, the date of the last valid disease assessment before initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first. PR per IMWG criteria was defined as \\>=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \\>=90% or to \\<200 mg/24 h. In addition to the above listed criteria, if present at baseline, a \\>=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"Analysis was performed on ITT population. Analysis was performed by Kaplan-Meier method.","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":"Time to First Response: Primary Analysis","type":"SECONDARY","unitOfMeasure":"months"}