{"analyses":[{"ciLowerLimit":"1.85","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.86","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"3","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"77.2","upperLimit":"85.4","value":"81.6"},{"groupId":"OG001","lowerLimit":"89.8","upperLimit":"95.3","value":"92.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"369"},{"groupId":"OG001","value":"368"}],"units":"Participants"}],"description":"ORR was the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR: \\>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \\>=90% or to \\<200 mg/24 hours. If serum and urine M-protein were not measurable, a decrease of \\>=50% in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. If present at baseline, a \\>=50% reduction in the size of soft tissue plasmacytomas was also required. VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis or \\>=90% reduction in serum M-protein plus urine M-protein \\<100 mg/24 hours. CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and \\< 5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC.","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":"NUMBER","populationDescription":"ITT population included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization (Day -3) up to 6.6 years","title":"Overall Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}