{"analyses":[{"ciLowerLimit":"0.496","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.941","estimateComment":"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.","groupDescription":"\\[Not specified\\]","groupIds":["OG000","OG001"],"nonInferiorityComment":"\\[Not specified\\]","nonInferiorityType":"SUPERIORITY","paramType":"[Stratified Hazard Ratio]","paramValue":"0.683"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"24.049","upperLimit":"40.509","value":"35.58"},{"comment":"Upper limit of confidence interval could not be calculated because not enough participants with PFS2 events.","groupId":"OG001","lowerLimit":"38.111","upperLimit":"NA","value":"47.18"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"description":"PFS2 defined as time (in months) from date of randomization to date of 1st documentation of PD (as assessed by investigator) after initiation of further anti-myeloma treatment /death from any cause, whichever comes 1st. Participants alive without progression after initiation of further anti-myeloma treatment before analysis cut-off date, PFS2 censored at date of last follow-up visit not showing disease progression after initiation of further anti-myeloma treatment /analysis cut-off date, whichever comes 1st. As per IMWG criteria, PD: defined for participants with increase of \\>= 25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be \\>= 0.5 g/dL), serum M-protein increase \\>=1 g/dL if lowest M component was \\>=5 g/dL; urine M-component (absolute increase must be \\>=200 mg/24hour), appearance of new lesion(s), \\>=50% increase from nadir in SPD of \\>1 lesion, or \\>=50% increase in longest diameter of previous lesion \\>1 centimeter 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 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":"Second Progression Free Survival (PFS2): Final Analysis - Data Cut-off Date of 14 Jan 2022","type":"SECONDARY","unitOfMeasure":"months"}