{"analyses":[{"ciLowerLimit":"0.387","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.727","groupDescription":"PFS Based on Frailty Status of Fit","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), and age (\\<75 vs \\>=75 years) at randomization.\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), and age (\\<75 vs \\>=75 years) at randomization, 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":"0.530","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.526","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.058","groupDescription":"PFS Based on Frailty Status of Unfit","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), and age (\\<75 vs \\>=75 years) at randomization.\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), and age (\\<75 vs \\>=75 years) at randomization, 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":"=0.098","paramType":"Hazard Ratio (HR)","paramValue":"0.746","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.481","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.117","groupDescription":"PFS Based on Frailty Status of Frail","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), and age (\\<75 vs \\>=75 years) at randomization.\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), and age (\\<75 vs \\>=75 years) at randomization, 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":"=0.147","paramType":"Hazard Ratio (HR)","paramValue":"0.733","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.502","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.602","groupDescription":"OS Based on Frailty Status of Fit","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":"=0.714","paramType":"Hazard Ratio (HR)","paramValue":"0.897","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.850","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.601","groupDescription":"OS Based on Frailty Status of Unfit","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":"=0.124","paramType":"Hazard Ratio (HR)","paramValue":"1.750","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.448","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.627","groupDescription":"OS Based on Frailty Status of Frail","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":"=0.630","paramType":"Hazard Ratio (HR)","paramValue":"0.854","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.39","upperLimit":"10.41","value":"8.5"},{"groupId":"OG001","lowerLimit":"12.75","upperLimit":"25.63","value":"18.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"172"}],"units":"Participants"}],"title":"PFS Based on Frailty Status of Fit"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.39","upperLimit":"14.23","value":"10.6"},{"groupId":"OG001","lowerLimit":"13.17","upperLimit":"21.78","value":"17.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"147"}],"units":"Participants"}],"title":"PFS Based on Frailty Status of Unfit"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.44","upperLimit":"15.67","value":"11.1"},{"groupId":"OG001","lowerLimit":"11.10","upperLimit":"23.75","value":"15.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"102"}],"units":"Participants"}],"title":"PFS Based on Frailty Status of Frail"},{"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":"112"},{"groupId":"OG001","value":"172"}],"units":"Participants"}],"title":"OS Based on Frailty Status of Fit"},{"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 and lower limit of CI were not estimable due to censoring.","groupId":"OG001","lowerLimit":"39.59","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"147"}],"units":"Participants"}],"title":"OS Based on Frailty Status of Unfit"},{"categories":[{"measurements":[{"comment":"Upper limit of CI was not estimable due to censoring.","groupId":"OG000","lowerLimit":"29.93","upperLimit":"NA","value":"42.5"},{"groupId":"OG001","lowerLimit":"34.30","upperLimit":"46.52","value":"46.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"102"}],"units":"Participants"}],"title":"OS Based on Frailty Status of Frail"}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"172"}],"units":"Participants"}],"description":"Participant's frailty status is classified as fit, unfit or frail on the bases of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. 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 occurs first, assessed for up to 52 months in this outcome measure. OS will be measured as the time from the date of randomization to the date of death, assessed for up to 52 months 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 analysis for the specified category.","reportingStatus":"POSTED","timeFrame":"From randomization up to 52 months","title":"Correlation Between Frailty Status and PFS and OS","type":"SECONDARY","unitOfMeasure":"months"}