{"analyses":[{"ciLowerLimit":"0.318","ciNumSides":"TWO_SIDED","ciPctValue":"99","ciUpperLimit":"0.889","estimateComment":"Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \\>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.","groupDescription":"Statistical analysis for comparison of PFS between the Kd and IKd arms based on primary analysis.","groupIds":["OG000","OG001"],"nonInferiorityComment":"For PFS, the nominal significance levels at primary analysis was determined using alpha-spending function in order to control overall 1-sided type 1 error at 2.5%. The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis (103 PFS events) was 0.005. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.","nonInferiorityType":"SUPERIORITY","pValue":"0.0007","pValueComment":"One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.005.","paramType":"Hazard Ratio (HR)","paramValue":"0.531","statisticalComment":"Stratified on number of prior lines of therapy (1 vs \\>1) \\& revised international staging system stage (I/II vs III vs not classified) as per IRT.","statisticalMethod":"Stratified Log-Rank test"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of the confidence interval could not be reached due to less number of participants with the events.","groupId":"OG000","lowerLimit":"15.770","upperLimit":"NA","value":"19.15"},{"comment":"Median value and the upper and lower limit of the confidence interval could not be calculated because of less than 50% of the participants had PFS events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"description":"Time (in months) from randomization to date of 1st documentation of progressive disease (PD)/date of death from any cause, whichever comes 1st. If PD \\& death are not observed before cut-off date/date of initiation of further anti-myeloma treatment, PFS was censored at date of last valid disease assessment not showing PD performed prior to initiation of further anti-myeloma treatment/cut-off date, whichever comes 1st. PD(IMWG criteria):any 1 of following:Increase(inc) of \\>=25% in serum M-component from nadir; serum M component inc \\>=1 g/dL in 2 consecutive assessment, if starting M component \\>=5 g/dL; and/or inc of \\>=25% in urine M-component from nadir and/or development of new bone lesion/soft tissue extramedullary disease/inc \\>=50% from nadir in sum of perpendicular diameters of existing soft tissue extramedullary disease lesion if \\>1 lesion/ \\>=50% increase in longest diameter of previous soft tissue extramedullary disease lesion \\>1 cm in short axis. Estimated by Kaplan-Meier method.","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 Intent to Treat (ITT) population that included all participants who gave their informed consent and for whom there was a confirmation of successful allocation of a randomization number by the interactive response technology (IRT).","reportingStatus":"POSTED","timeFrame":"From randomization until the primary analysis data cut-off date of 7 Feb 2020 (median duration of follow-up was 20.73 months)","title":"Progression Free Survival (PFS) As Determined by Independent Response Committee (IRC): Primary Analysis","type":"PRIMARY","unitOfMeasure":"months"}