{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"}]}],"title":"ECOG Score 0"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"ECOG Score 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"}],"units":"Participants"}],"description":"ECOG PS was used to assess physical health of participants. ECOG PS grade:0= fully active, able to carry on all pre-disease performance without restriction,1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Only those categories with non-zero values were reported.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Ixazomib Safety Population (ISP) included all participants who received at least 1 dose of ixazomib. As prespecified in the SAP, the ISP contained only one arm i.e., Ixazomib (participants originally randomized to ixazomib + participants who were randomized to the placebo arm prior to implementation of Amendment 08 and who crossed over to ixazomib arm contributing data for this outcome measure from the time they initiated ixazomib onward), thus data is presented accordingly.","reportingStatus":"POSTED","timeFrame":"Month 25","title":"Number of Participants Categorized According to Performance Status (PS) Based on Eastern Cooperative Oncology Group (ECOG) PS","type":"PRIMARY","unitOfMeasure":"Participants"}