{"analyses":[{"ciLowerLimit":"0.789","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.332","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":"0.850","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":"1.025","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median and upper limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.","groupId":"OG000","lowerLimit":"96.95","upperLimit":"NA","value":"NA"},{"comment":"Median and upper limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.","groupId":"OG001","lowerLimit":"104.97","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"261"},{"groupId":"OG001","value":"395"}],"units":"Participants"}],"description":"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.","reportingStatus":"POSTED","timeFrame":"Randomization up to end of follow up period (up to 107 months)","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}