{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.7","upperLimit":"6.3","value":"4"},{"groupId":"OG001","lowerLimit":"5.2","upperLimit":"9.7","value":"7.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"245"},{"groupId":"OG001","value":"262"}],"units":"Participants"}],"title":"Month 3"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.4","upperLimit":"11.3","value":"8.8"},{"groupId":"OG001","lowerLimit":"6.2","upperLimit":"10.8","value":"8.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"235"}],"units":"Participants"}],"title":"Month 6"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.7","upperLimit":"12.8","value":"10.2"},{"groupId":"OG001","lowerLimit":"8.2","upperLimit":"12.9","value":"10.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"228"}],"units":"Participants"}],"title":"Month 9"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.2","upperLimit":"13.3","value":"10.7"},{"groupId":"OG001","lowerLimit":"9","upperLimit":"13.7","value":"11.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"222"}],"units":"Participants"}],"title":"Month 12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9","upperLimit":"14.6","value":"11.8"},{"groupId":"OG001","lowerLimit":"10.3","upperLimit":"15.3","value":"12.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"195"}],"units":"Participants"}],"title":"Month 18"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.1","upperLimit":"15","value":"11.5"},{"groupId":"OG001","lowerLimit":"6.8","upperLimit":"12.1","value":"9.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"152"}],"units":"Participants"}],"title":"Month 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.1","upperLimit":"14.5","value":"10.8"},{"groupId":"OG001","lowerLimit":"9.2","upperLimit":"14.5","value":"11.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"159"}],"units":"Participants"}],"title":"Month 30"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.2","upperLimit":"12.9","value":"8.6"},{"groupId":"OG001","lowerLimit":"9.1","upperLimit":"14.6","value":"11.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"title":"Month 36"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.3","upperLimit":"9.9","value":"4.8"},{"groupId":"OG001","lowerLimit":"7.5","upperLimit":"13.3","value":"10.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"125"}],"units":"Participants"}],"title":"Month 42"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"14.9","value":"8.9"},{"groupId":"OG001","lowerLimit":"6.6","upperLimit":"12.9","value":"9.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"102"}],"units":"Participants"}],"title":"Month 48"}],"denoms":[{"counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"317"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 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). The questionnaire includes 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 QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values for function and GHS scale indicated deterioration in quality of life or functioning and positive values indicate improvement.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m\\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. 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). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab.","id":"OG000","title":"Velcade, Melphalan and Prednisone (VMP)"},{"description":"Participants received Velcade 1.3 mg/m\\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab 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, Velcade, Melphalan and Prednisone (D-VMP)"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"ITT population: participants randomized into the study; classified according to assigned treatment group, regardless actual treatment received. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.","reportingStatus":"POSTED","timeFrame":"Baseline (Day -24), Months 3, 6, 9, 12 ,18, 24, 30, 36, 42 and 48","title":"Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Global Health Scale","type":"SECONDARY","unitOfMeasure":"Units on a scale"}