{"analyses":[{"ciLowerLimit":"0.052","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.650","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.0032","paramType":"Hazard Ratio (HR)","paramValue":"0.184","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The median PFS was not reached in Arm A. There were insufficient numbers of participants with events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The upper confidence limit was not available due to insufficient numbers of participants with events.","groupId":"OG001","lowerLimit":"3.38","upperLimit":"NA","value":"4.86"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"description":"Time from the date of randomization to the date of first documentation of confirmed progressive disease (PD) or death due to any cause, whichever occurred first.","dispersionType":"95% Confidence Interval","groups":[{"description":"Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7","id":"OG000","title":"Arm A (Melflufen+Dexamethasone+Daratumumab)"},{"description":"Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7","id":"OG001","title":"Arm B (Daratumumab)"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed using the Full Analysis Set (FAS).","reportingStatus":"POSTED","timeFrame":"From the date of randomization until the end of study (approximately 12 months).","title":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}