{"analyses":[{"ciLowerLimit":"0.583","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.613","estimateComment":"Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.905","pValueComment":"P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.","paramType":"Hazard Ratio (HR)","paramValue":"0.97","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"33.25","upperLimit":"92.98","value":"69.0"},{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG001","lowerLimit":"40.97","upperLimit":"NA","value":"64.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"61"}],"units":"Participants"}],"description":"High-risk population included but was not limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS was measured as the time from the date of randomization to the date of death.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.","id":"OG000","title":"Placebo"},{"description":"Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.","id":"OG001","title":"Ixazomib Citrate"}],"paramType":"MEDIAN","populationDescription":"ITT population was defined as all participants who were randomized and had post randomization data. Overall number analyzed is the number of participants present in the high-risk group.","reportingStatus":"POSTED","timeFrame":"Randomization up to 107 months","title":"OS Benefits in a High-Risk Population","type":"SECONDARY","unitOfMeasure":"months"}