{"classes":[{"categories":[{"measurements":[{"comment":"Median and upper limit of 95% CI were not estimable due to censoring.","groupId":"OG000","lowerLimit":"12.68","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"}],"units":"Participants"}],"title":"Frailty Status: Fit"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI was not estimable due to censoring.","groupId":"OG000","lowerLimit":"0.89","upperLimit":"NA","value":"20.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"title":"Frailty Status: Unfit"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI was not estimable due to censoring.","groupId":"OG000","lowerLimit":"6.18","upperLimit":"NA","value":"6.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"title":"Frailty Status: Frail"}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"}],"units":"Participants"}],"description":"Participant's frailty status is classified as fit, unfit, or frail on the basis 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 first dose of study drug to the first occurrence of PD as evaluated by the investigator.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).","id":"OG000","title":"Ixazomib"}],"paramType":"MEDIAN","populationDescription":"Efficacy Population included all participants who received ixazomib treatment for the duration of their study participation. Number analyzed is the number of participants with data available for analysis for the specified category. As prespecified in the SAP, the Efficacy Population contained only one arm i.e., Ixazomib (efficacy outcomes data for the participants who received placebo before Protocol Amendment 8 was not collected per SAP), thus data is presented accordingly.","reportingStatus":"POSTED","timeFrame":"Up to 58.4 months","title":"Correlation Between Frailty Status and PFS","type":"SECONDARY","unitOfMeasure":"months"}