{"analyses":[{"ciLowerLimit":"-0.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.2","groupDescription":"For Cycle 3 Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.0986","paramType":"Least Square Mean Difference","paramValue":"2.4","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.4","groupDescription":"Cycle 6 Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.3042","paramType":"Least Square Mean Difference","paramValue":"1.5","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.9","groupDescription":"Cycle 9 Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.2339","paramType":"Least Square Mean Difference","paramValue":"1.8","statisticalMethod":"Mixed Models 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Analysis"},{"ciLowerLimit":"-3.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5","groupDescription":"Cycle 48 Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.7296","paramType":"Least Square Mean","paramValue":"0.8","statisticalMethod":"Least Square Mean Difference"},{"ciLowerLimit":"-6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.3","groupDescription":"Cycle 54 Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.5793","paramType":"Least Square Mean Difference","paramValue":"-1.3","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-6.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.5","groupDescription":"Cycle 60 Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.7756","paramType":"Least Square Mean Difference","paramValue":"-0.8","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.4","groupDescription":"Cycle 66 Day 1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.8458","paramType":"Least Square Mean Difference","paramValue":"0.7","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.7","upperLimit":"3.5","value":"1.4"},{"groupId":"OG001","lowerLimit":"1.7","upperLimit":"5.8","value":"3.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"295"},{"groupId":"OG001","value":"314"}],"units":"Participants"}],"title":"Cycle 3 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.6","upperLimit":"7","value":"4.8"},{"groupId":"OG001","lowerLimit":"4.3","upperLimit":"8.4","value":"6.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"304"}],"units":"Participants"}],"title":"Cycle 6 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.4","upperLimit":"8","value":"5.7"},{"groupId":"OG001","lowerLimit":"5.4","upperLimit":"9.7","value":"7.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"278"}],"units":"Participants"}],"title":"Cycle 9 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.2","upperLimit":"6.8","value":"4.5"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"9.9","value":"7.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"274"}],"units":"Participants"}],"title":"Cycle 12 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.2","upperLimit":"7.2","value":"4.7"},{"groupId":"OG001","lowerLimit":"4.1","upperLimit":"8.6","value":"6.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"186"},{"groupId":"OG001","value":"253"}],"units":"Participants"}],"title":"Cycle 18 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"7.4","value":"4.7"},{"groupId":"OG001","lowerLimit":"4.1","upperLimit":"8.6","value":"6.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"161"},{"groupId":"OG001","value":"238"}],"units":"Participants"}],"title":"Cycle 24 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.7","upperLimit":"7.3","value":"4.5"},{"groupId":"OG001","lowerLimit":"3.1","upperLimit":"7.9","value":"5.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"213"}],"units":"Participants"}],"title":"Cycle 30 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2","upperLimit":"8","value":"5"},{"groupId":"OG001","lowerLimit":"5.3","upperLimit":"10.1","value":"7.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"207"}],"units":"Participants"}],"title":"Cycle 36 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","upperLimit":"7","value":"3.8"},{"groupId":"OG001","lowerLimit":"3.1","upperLimit":"8.1","value":"5.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"184"}],"units":"Participants"}],"title":"Cycle 42 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.1","upperLimit":"6.9","value":"3.4"},{"groupId":"OG001","lowerLimit":"1.6","upperLimit":"6.7","value":"4.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"170"}],"units":"Participants"}],"title":"Cycle 48 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.2","upperLimit":"9.9","value":"6.1"},{"groupId":"OG001","lowerLimit":"2","upperLimit":"7.5","value":"4.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Cycle 54 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.4","upperLimit":"9.4","value":"4.9"},{"groupId":"OG001","lowerLimit":"1.1","upperLimit":"7.1","value":"4.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"title":"Cycle 60 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.3","upperLimit":"12.8","value":"7.1"},{"groupId":"OG001","lowerLimit":"4.2","upperLimit":"11.2","value":"7.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"78"}],"units":"Participants"}],"title":"Cycle 66 Day 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"295"},{"groupId":"OG001","value":"314"}],"units":"Participants"}],"description":"EORTC QLQ-C30 was 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire included 28 items with 4-point Likert type responses from \"1-not at all\" to \"4-very much\" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores were transformed to 0 to 100 scale, with higher scores represented better GHS and functioning, and more symptoms. Negative change from baseline values showed deterioration in quality of life or functioning and reduction in symptom and positive values indicated improvement and worsening of symptoms.","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":"LEAST_SQUARES_MEAN","populationDescription":"ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.","reportingStatus":"POSTED","timeFrame":"Baseline (Day -24) and Day 1 of Cycles 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 66 (each Cycle of 28 days)","title":"Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score","type":"SECONDARY","unitOfMeasure":"Score on scale"}