{"analyses":[{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.73","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.56","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Here NA signifies upper limit of confidence interval (CI) was not estimable due to an insufficient number of events.","groupId":"OG000","lowerLimit":"28.94","upperLimit":"NA","value":"31.87"},{"comment":"Here 'NA' signifies median and CI was not estimable due to an insufficient number of events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"369"},{"groupId":"OG001","value":"368"}],"units":"Participants"}],"description":"PFS was defined as time from date of randomization to either progressive disease (PD) or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD was defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to \\[\\>=\\] 0.5 gram per deciliter \\[g/dL\\] and \\>=200 milligram \\[mg\\]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than \\[\\>\\]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL) that could be attributed solely to Plasma cell (PC) proliferative disorder.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \\[IMWG\\] criteria).","id":"OG000","title":"Lenalidomide + Dexamethasone (Rd)"},{"description":"Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).","id":"OG001","title":"Daratumumab + Lenalidomide + Dexamethasone (DRd)"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat (ITT) population included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"Months"}