{"analyses":[{"ciLowerLimit":"0.269","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.672","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.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Stratified Hazard Ratio","paramValue":"0.425"}],"classes":[{"categories":[{"measurements":[{"comment":"Median and upper limit of confidence interval could not be calculated because of less than 50% of the participants reaching PR or better with PFS events (PFS events includes progression and death without progression).","groupId":"OG000","lowerLimit":"14.752","upperLimit":"NA","value":"NA"},{"comment":"Median and the upper and lower limit of confidence interval could not be calculated because of less than 50% of the participants reaching PR or better with PFS events (PFS events includes progression and death without progression).","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"155"}],"units":"Participants"}],"description":"DOR: time (in months) from date of 1st IRC determined response for participants achieving PR/better to date of 1st documented PD determined by IRC/death, whichever happens 1st. If disease progression/death before analysis cut-off date was not observed, DOR was censored at date of last valid disease assessment performed prior to initiation of further anti-myeloma treatment/data cut-off date, whichever was 1st. PD (IMWG criteria): inc of \\>=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute inc must be \\>=0.5 g/dL), serum M-protein inc \\>=1g/dL if lowest M component was \\>=5g/dL; urine M-component (absolute inc must be \\>=200mg/24 hour),appearance of new lesion(s), \\>=50% inc from nadir in SPD of \\>1 lesion, or \\>=50% inc in the longest diameter of previous lesion \\>1 cm in short axis. PR: \\>=50% reduction of serum M-protein \\& reduction in 24h urinary M-protein by \\>=90%/\\<200mg/24 h. 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 the subset of participants with PR or better (defined as responders) in ITT population.","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":"Duration of Response (DOR): Primary Analysis","type":"SECONDARY","unitOfMeasure":"months"}