{"analyses":[{"ciLowerLimit":"0.678","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.845","estimateComment":"Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\\<75 years vs \\>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\\<4 vs \\>=4) at screening.","groupDescription":"OS in High-risk Population Carrying Del(17p), Amp(1q21), t(4;14), or t(14;16) Mutations","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.662","paramType":"Hazard Ratio (HR)","paramValue":"1.118","statisticalComment":"Log-rank test is stratified by age (\\<75 years vs \\>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\\<4 vs \\>=4) at screening.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"33.84","upperLimit":"57.82","value":"43.1"},{"comment":"Upper range of CI was not estimable due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"25.43","upperLimit":"NA","value":"39.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"60"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization to the date of death, as assessed in high-risk population carrying del(17p), t(4;14), or t(14;16) mutations. High risk category includes t(4;14), t(14;16), or del(17) abnormalities.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).","id":"OG000","title":"Placebo + LenDex"},{"description":"Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).","id":"OG001","title":"Ixazomib + LenDex"}],"paramType":"MEDIAN","populationDescription":"ITT population included all participants who were randomized. Overall number of participants analyzed indicates the number of participants from the high-risk category.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to death due to any cause (Up to approximately 9 years)","title":"OS in High-risk Population Carrying Del(17p), t(4;14), or t(14;16) Mutations","type":"SECONDARY","unitOfMeasure":"months"}