{"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of CI was not estimable due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"13.24","upperLimit":"NA","value":"18.7"},{"groupId":"OG001","lowerLimit":"7.36","upperLimit":"15.70","value":"9.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"62"}],"units":"Participants"}],"description":"Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).","id":"OG000","title":"Ixazomib+ Lenalidomide + Dexamethasone"},{"description":"Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).","id":"OG001","title":"Placebo + Lenalidomide + Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"Participants from the ITT population, all randomized participants, with cytogenic abnormalities. Overall number analyzed is the number of participants available for analysis.","reportingStatus":"POSTED","timeFrame":"From date of randomization until disease progression or death up to approximately 38 months (approximate median follow-up 15 months)","title":"PFS in High-Risk Participants","type":"SECONDARY","unitOfMeasure":"months"}