{"analyses":[{"ciLowerLimit":"0.777","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.246","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"P-value comparing PFS2 between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.","pValue":"=0.893","paramType":"Hazard Ratio (HR)","paramValue":"0.984","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"40.05","upperLimit":"62.46","value":"50.3"},{"groupId":"OG001","lowerLimit":"44.91","upperLimit":"63.41","value":"51.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"425"}],"units":"Participants"}],"description":"PFS2 is defined as the time from the date of randomization to objective PD on next-line treatment using IMWG criteria, or death due to any cause, whichever occurred first.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.","id":"OG000","title":"Placebo"},{"description":"Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.","id":"OG001","title":"Ixazomib"}],"paramType":"MEDIAN","populationDescription":"ITT Population included all participants who were randomized and had post-randomization data.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to every 12 weeks until second PD or death (up to 88 months)","title":"Progression Free Survival 2 (PFS2)","type":"SECONDARY","unitOfMeasure":"months"}