{"analyses":[{"ciLowerLimit":"2.37","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.57","estimateComment":"Odds ratio and 95% CI were estimated by Mantel-Haenszel method. Stratification factor included baseline cytogenetic risk per investigator's assessment (high risk versus standard/unknown risk) as used for randomization of the study.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Tested at 2-sided 0.05 significance level through stratified CMH method. Stratification factor included baseline cytogenetic risk per investigator'","paramType":"Odds Ratio (OR)","paramValue":"4.51","statisticalMethod":"stratified Cochran-Mantel-Haenszel (CMH)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"40.3","upperLimit":"60.7","value":"50.5"},{"groupId":"OG001","lowerLimit":"11.7","upperLimit":"27.8","value":"18.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"101"}],"units":"Participants"}],"description":"Percentage of participants who achieved MRD negative (MRD conversion) status from baseline to 12 months after maintenance treatment was defined as percentage of participants who were MRD positive at baseline (randomization) and achieved MRD negative status (at 10\\^-5) during the time period from randomization to 12 months plus 2 months window, but prior to progressive disease (PD) and subsequent anti-myeloma therapy.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received daratumumab 1800 milligrams (mg) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.","id":"OG000","title":"Daratumumab + Lenalidomide"},{"description":"Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.","id":"OG001","title":"Lenalidomide"}],"paramType":"NUMBER","populationDescription":"The full analysis set (FAS) which included all participants randomly assigned to daratumumab in combination with lenalidomide or the lenalidomide alone.","reportingStatus":"POSTED","timeFrame":"From randomization up to 12 months","title":"Percentage of Participants Who Had Minimal Residual Disease (MRD) Conversion From Baseline to 12 Months After Start of Maintenance Treatment as Determined by Next Generation Sequencing (NGS)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}