{"analyses":[{"ciLowerLimit":"0.317","ciNumSides":"TWO_SIDED","ciPctValue":"99.2","ciUpperLimit":"0.948","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 arm based on primary analysis.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis was 0.004. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.","nonInferiorityType":"SUPERIORITY","pValue":"0.0016","pValueComment":"One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.004.","paramType":"Hazard Ratio (HR)","paramValue":"0.548","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":"20.27"},{"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 PD documentation/death date, whichever is 1st. If PD \\& death not observed before cut-off date/date of further anti-myeloma treatment initiation, PFS censored at date of last valid disease assessment not showing PD performed prior to initiation of further anti-myeloma treatment/cut-off date, whichever was 1st. Progression/deaths occurring \\>8 weeks after last disease assessment censored at earliest date of last disease assessment without evidence of progression before initiation of new anti-myeloma treatment \\& cut-off date. PD (IMWG criteria): meeting any 1: Inc \\>=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 \\>=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 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: 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 the ITT. 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":"Progression Free Survival as Determined by Independent Response Committee: [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Primary Analysis","type":"PRIMARY","unitOfMeasure":"months"}