{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2243","value":"0.6748"},{"groupId":"OG001","spread":"0.2086","value":"0.6803"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"48"}],"units":"Participants"}],"title":"Baseline value"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.1848","value":"-0.0228"},{"groupId":"OG001","spread":"0.1846","value":"-0.0502"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"title":"Cycle 2 Day 1 Change from baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2187","value":"-0.0169"},{"groupId":"OG001","spread":"0.1919","value":"0.0038"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"Cycle 4 Day 1 Change from baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.3049","value":"-0.0786"},{"groupId":"OG001","spread":"0.3309","value":"-0.1486"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Cycle 6 Day 1 Change from baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2320","value":"-0.1461"},{"groupId":"OG001","spread":"0.2464","value":"-0.2174"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Cycle 8 Day 1 Change from baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2594","value":"-0.0014"},{"groupId":"OG001","spread":"0.2552","value":"0.0124"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"title":"End of Treatment Change from baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"48"}],"units":"Participants"}],"description":"Change from baseline in Patient Reported Outcome questionnaire EQ-5D-3L. The EQ-5D-3L questionnaire converts 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression of patient-reported, current-day health status into a \"health utility\" score. For the EQ-5D-3L questionnaire, each dimension is scored on an ordinal scale with 3 available levels of response and scores ranging from 1 to 3, \"no problems,\" \"some problems,\" and \"extreme problems,\" respectively. The EQ VAS scores rates \"health today\" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). No imputation of missing items or composite scores were done. The scores for the 5 dimensions are used to compute a single utility score ranging from zero (0.0) to 1 (1.0) representing the general health status of the individual.","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: EQ-5D-3L","type":"SECONDARY","unitOfMeasure":"Change in composite scale score"}