{"analyses":[{"ciLowerLimit":"0.594","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.015","estimateComment":"Stratified on age (\\<75 years versus \\>=75 years) and number of previous lines of therapy (2 or 3 versus \\> 3) according to IRT.","groupIds":["OG000","OG001"],"nonInferiorityComment":"A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.","nonInferiorityType":"SUPERIORITY","pValue":"0.0319","pValueComment":"One-sided significance level was 0.02 using the O'Brien-Fleming alpha spending function.","paramType":"Hazard Ratio (HR)","paramValue":"0.776","statisticalComment":"Stratified on age (\\<75 years versus \\>=75 years) and number of previous lines of therapy (2 or 3 versus \\> 3) according to IRT.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.390","upperLimit":"26.218","value":"17.71"},{"groupId":"OG001","lowerLimit":"20.304","upperLimit":"31.310","value":"24.57"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"154"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first. This pre-specified final analysis was performed when the 220 OS events were met.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \\>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).","id":"OG000","title":"Pd (Pomalidomide + Dexamethasone)"},{"description":"Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \\>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).","id":"OG001","title":"IPd (Isatuximab + Pomalidomide + Dexamethasone)"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed on ITT population.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to date of death from any cause or data cut-off date, whichever was earlier (maximum duration 245.6 weeks)","title":"Overall Survival (OS): Final Analysis","type":"SECONDARY","unitOfMeasure":"months"}