{"analyses":[{"ciLowerLimit":"0.425","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.796","groupDescription":"PFS for Participants with Known MRD+ at Study Entry","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"P-value comparing PFS 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":"=0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.582","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.563","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.194","groupDescription":"PFS for Participants with Known MRD- at Study Entry","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"P-value comparing PFS 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":"=0.398","paramType":"Hazard Ratio (HR)","paramValue":"1.537","statisticalMethod":"Log Rank"},{"ciLowerLimit":"1.194","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"86.649","groupDescription":"OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"P-value comparing OS 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":"=0.012","paramType":"Hazard Ratio (HR)","paramValue":"10.173","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.75","upperLimit":"11.99","value":"9.3"},{"groupId":"OG001","lowerLimit":"13.47","upperLimit":"21.29","value":"16.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"169"}],"units":"Participants"}],"title":"PFS for Participants with Known MRD+ at Study Entry"},{"categories":[{"measurements":[{"comment":"Median and upper limit of confidence interval (CI) were not estimable due to censoring.","groupId":"OG000","lowerLimit":"23.69","upperLimit":"NA","value":"NA"},{"comment":"Upper limit of CI was not estimable due to censoring.","groupId":"OG001","lowerLimit":"26.94","upperLimit":"NA","value":"40.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"title":"PFS for Participants with Known MRD- at Study Entry"},{"categories":[{"measurements":[{"comment":"Median, upper, and lower limit of CI were not estimable due to censoring.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median, upper, and lower limit of CI were not estimable due to censoring.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"213"}],"units":"Participants"}],"title":"OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry"}],"denoms":[{"counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"213"}],"units":"Participants"}],"description":"PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 52 months in this outcome measure. OS was measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure. Participants with various types of known MRD status were pooled together for analysis of overall survival in this outcome measure.","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. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified category.","reportingStatus":"POSTED","timeFrame":"From randomization up to 52 months","title":"Correlation of MRD Status With PFS and OS","type":"SECONDARY","unitOfMeasure":"months"}