{"analyses":[{"ciLowerLimit":"0.36","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.67","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.49","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"26.41","upperLimit":"53.32","value":"41.46"},{"comment":"Here \"NA\" signifies that median and upper limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.","groupId":"OG001","lowerLimit":"66.69","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"194"}],"units":"Participants"}],"description":"PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (\\>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio \\>=100, greater than (\\>)1 focal bone lesions on magnetic resonance imaging (MRI), calcium elevation, renal insufficiency by creatinine clearance, anemia, or bone disease due to lytic bone lesions. Kaplan-Meier estimate was used.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.","id":"OG000","title":"Arm A: Active Monitoring (ACTM)"},{"description":"Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).","id":"OG001","title":"Arm B: Daratumumab SC"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat (ITT) analysis set included all participants randomized into the study.","reportingStatus":"POSTED","timeFrame":"From randomization (Day -5) up to 77 months","title":"Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)","type":"PRIMARY","unitOfMeasure":"Months"}