{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.2","value":"75.5"},{"groupId":"OG001","spread":"13.0","value":"74.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"48"}],"units":"Participants"}],"title":"Baseline value"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.9","value":"0.2"},{"groupId":"OG001","spread":"13.7","value":"74.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"title":"Cycle 2 Day 1 Change from baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.8","value":"-2.6"},{"groupId":"OG001","spread":"11.9","value":"76.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"title":"Cycle 4 Day 1 Change from baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.5","value":"-3.3"},{"groupId":"OG001","spread":"12.6","value":"73.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"title":"Cycle 6 Day 1 Change from baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.6","value":"-7.5"},{"groupId":"OG001","spread":"11.3","value":"71.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Cycle 8 Day 1 Change from baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"48"}],"units":"Participants"}],"description":"Change from baseline in Patient Reported Outcome questionnaire EORTC QLQ-C30. The EORTC QLQ-C30 includes 30 items resulting in 5 functional scales, 1 Global Health Status scale, 3 symptom scales, and 6 single items. The recall period is 1 week (the past week). The scales are transformed to a 0 (worst) to 100 (best) scale. The QLQ-C30 summary score is calculated as the mean of the combined 13 QLQ-C30 scale and item scores (excluding global QoL and financial impact), with a higher score indicating a better HRQoL. If at least 50% of the items from the scale had been answered, the missing items were assumed to have values equal to the average of those items which were present for that respondent.","dispersionType":"Standard Deviation","groups":[{"description":"Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.\n\nMelphalan flufenamide (Melflufen)\n\nDexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.","id":"OG000","title":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set"},{"description":"Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody","id":"OG001","title":"Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease"}],"paramType":"MEAN","populationDescription":"This outcome measure was prespecified to be analyzed/reported for the Mel + Dex: FAS Arm/Group and Mel + Dex: Patients With TCR Disease.\n\n62 pts in the FAS included after QoL was added in Amd 4, whereof 48 pts in the sub-group of pts with TCR disease.\n\nThis outcome measure was not analyzed/reported separately for the sub-group of patients with EMD as there were limited no. of pts with EMD among the QoL patients. No data/results are available to report for patients with EMD.","reportingStatus":"POSTED","timeFrame":"To be assessed prior to dosing at Cycle 1, 2, 4, 6, 8, and End of Treatment. 23 patients were ongoing for QoL assessments at data cutoff. QoL was added in Protocol Amendment 4 beginning in Oct. 2018.","title":"Functional Status and Well-being: EORTC QLQ-C30","type":"SECONDARY","unitOfMeasure":"units on a scale"}