{"analyses":[{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.76","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.61","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"44.09","upperLimit":"56.57","value":"48.89"},{"comment":"Here 'NA' signifies upper limit of 95% CI was not estimable due to an insufficient number of participants with events.","groupId":"OG001","lowerLimit":"73.72","upperLimit":"NA","value":"73.72"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"369"},{"groupId":"OG001","value":"368"}],"units":"Participants"}],"description":"PFS2 was defined as the time from randomization to progression on next line of therapy or death, whichever comes first. Disease progression on next line of treatment was based on investigator judgment.","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) up to 6.6 years","title":"Progression-free Survival on Next Line of Therapy (PFS2)","type":"SECONDARY","unitOfMeasure":"Months"}