{"analyses":[{"ciLowerLimit":"0.386","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.969","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.","groupDescription":"MRD- at Study Entry","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.034","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":"0.612","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.539","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.920","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.","groupDescription":"MRD+ at Study Entry","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.010","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":"0.704","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI was not estimable due to censoring.","groupId":"OG000","lowerLimit":"19.32","upperLimit":"NA","value":"32.5"},{"comment":"Upper limit of 95% CI was not estimable due to censoring.","groupId":"OG001","lowerLimit":"33.81","upperLimit":"NA","value":"38.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"117"}],"units":"Participants"}],"title":"MRD- at Study Entry"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.70","upperLimit":"21.91","value":"18.5"},{"groupId":"OG001","lowerLimit":"20.24","upperLimit":"25.69","value":"23.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"225"}],"units":"Participants"}],"title":"MRD+ at Study Entry"}],"denoms":[{"counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"342"}],"units":"Participants"}],"description":"PFS is defined as the time from the date of randomization to the date of first documentation of PD as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 107 months in this outcome measure.","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 with data available for analyses. Number analyzed indicates the number of participants available for analysis in the specified category.","reportingStatus":"POSTED","timeFrame":"From randomization up to 107 months","title":"Correlation Between MRD Status and Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}