{"analyses":[{"ciLowerLimit":"0.424","ciNumSides":"TWO_SIDED","ciPctValue":"95.4","ciUpperLimit":"0.832","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.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.594"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.164","upperLimit":"28.189","value":"20.76"},{"comment":"Upper limit of the confidence interval could not be reached due to less number of participants with the events.","groupId":"OG001","lowerLimit":"27.138","upperLimit":"NA","value":"41.66"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"description":"Time (in months) from randomization to date of 1st documentation of 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/cut-off date, whichever comes 1st. Progressions/deaths occurring \\>8 weeks after last disease assessment were censored at earliest date of last valid disease assessment not showing PD before initiation of further anti-myeloma treatment \\& cut-off date. PD (per IMWG criteria): meeting any 1 criteria: Inc of \\>=25% in serum M-component from nadir; serum M component inc \\>=1 g/dL in 2 consecutive assessment, if starting M component was \\>=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 \\>1 cm in short axis.","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: 208 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: 215 weeks).","id":"OG001","title":"Isatuximab + Carfilzomib + Dexamethasone (IKd)"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed on the ITT population. Analysis was performed by Kaplan-Meier method.","reportingStatus":"POSTED","timeFrame":"From randomization until the final analysis data cut-off date of 14 Jan 2022 (the median duration of follow-up was 43.96 months)","title":"Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis","type":"PRIMARY","unitOfMeasure":"months"}