{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.95","upperLimit":"1.09","value":"-0.43"},{"groupId":"OG001","lowerLimit":"-1.71","upperLimit":"1.34","value":"-0.19"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"148"}],"units":"Participants"}],"title":"Week 4"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.64","upperLimit":"0.46","value":"-1.09"},{"groupId":"OG001","lowerLimit":"-2.96","upperLimit":"0.12","value":"-1.42"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"144"}],"units":"Participants"}],"title":"Week 8"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.44","upperLimit":"-0.28","value":"-1.86"},{"groupId":"OG001","lowerLimit":"-1.74","upperLimit":"1.40","value":"-0.17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"135"}],"units":"Participants"}],"title":"Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.76","upperLimit":"-1.54","value":"-3.15"},{"groupId":"OG001","lowerLimit":"-1.94","upperLimit":"1.23","value":"-0.35"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"130"}],"units":"Participants"}],"title":"Week 16"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.04","upperLimit":"-0.68","value":"-2.36"},{"groupId":"OG001","lowerLimit":"-1.99","upperLimit":"1.16","value":"-0.42"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"134"}],"units":"Participants"}],"title":"Week 20"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.50","upperLimit":"0.82","value":"-1.84"},{"groupId":"OG001","lowerLimit":"-2.20","upperLimit":"1.01","value":"-0.60"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"125"}],"units":"Participants"}],"title":"Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.10","upperLimit":"-1.42","value":"-3.26"},{"groupId":"OG001","lowerLimit":"-3.74","upperLimit":"1.88","value":"-0.93"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"title":"Week 28"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.51","upperLimit":"3.89","value":"0.19"},{"groupId":"OG001","lowerLimit":"-1.09","upperLimit":"2.31","value":"0.61"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"103"}],"units":"Participants"}],"title":"Week 32"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.47","upperLimit":"4.57","value":"-0.45"},{"groupId":"OG001","lowerLimit":"-2.05","upperLimit":"4.49","value":"1.22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"Week 36"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.67","upperLimit":"3.54","value":"-0.56"},{"groupId":"OG001","lowerLimit":"0.30","upperLimit":"3.74","value":"2.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"99"}],"units":"Participants"}],"title":"Week 40"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.70","upperLimit":"6.30","value":"1.30"},{"groupId":"OG001","lowerLimit":"-1.73","upperLimit":"4.82","value":"1.55"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"Week 44"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.39","upperLimit":"2.91","value":"0.26"},{"groupId":"OG001","lowerLimit":"0.41","upperLimit":"3.94","value":"2.18"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"92"}],"units":"Participants"}],"title":"Week 48"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.57","upperLimit":"3.94","value":"0.69"},{"groupId":"OG001","lowerLimit":"-1.73","upperLimit":"4.39","value":"1.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Week 52"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.83","upperLimit":"3.13","value":"-0.35"},{"groupId":"OG001","lowerLimit":"-0.88","upperLimit":"2.71","value":"0.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"87"}],"units":"Participants"}],"title":"Week 56"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.39","upperLimit":"5.79","value":"2.20"},{"groupId":"OG001","lowerLimit":"-1.64","upperLimit":"4.28","value":"1.32"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"24"}],"units":"Participants"}],"title":"Week 60"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-6.28","upperLimit":"2.28","value":"-2.00"},{"groupId":"OG001","lowerLimit":"0.90","upperLimit":"4.58","value":"2.74"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"80"}],"units":"Participants"}],"title":"Week 64"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.81","upperLimit":"5.17","value":"0.68"},{"groupId":"OG001","lowerLimit":"-1.32","upperLimit":"3.83","value":"1.25"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"33"}],"units":"Participants"}],"title":"Week 68"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.26","upperLimit":"1.84","value":"-1.21"},{"groupId":"OG001","lowerLimit":"0.14","upperLimit":"3.92","value":"2.03"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"74"}],"units":"Participants"}],"title":"Week 72"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.07","upperLimit":"5.17","value":"1.05"},{"groupId":"OG001","lowerLimit":"-2.56","upperLimit":"2.80","value":"0.12"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"title":"Week 76"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.58","upperLimit":"3.52","value":"0.47"},{"groupId":"OG001","lowerLimit":"0.44","upperLimit":"4.20","value":"2.32"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"75"}],"units":"Participants"}],"title":"Week 80"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.77","upperLimit":"8.19","value":"3.21"},{"groupId":"OG001","lowerLimit":"-1.12","upperLimit":"4.25","value":"1.56"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"title":"Week 84"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.35","upperLimit":"6.59","value":"2.12"},{"groupId":"OG001","lowerLimit":"0.72","upperLimit":"4.42","value":"2.57"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"79"}],"units":"Participants"}],"title":"Week 88"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.78","upperLimit":"2.78","value":"-2.50"},{"groupId":"OG001","lowerLimit":"-1.40","upperLimit":"4.02","value":"1.31"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"29"}],"units":"Participants"}],"title":"Week 92"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.61","upperLimit":"3.55","value":"-0.03"},{"groupId":"OG001","lowerLimit":"0.96","upperLimit":"4.96","value":"2.96"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"title":"Week 96"}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"176"}],"units":"Participants"}],"description":"The SF-36 Health Survey was a generic measure of health status. The SF-36 consisted of 36 questions that yield an eight-scale (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) profile of functional health and well-being, as well as 2 physical and mental health summary measures and a preference-based health utility index. The physical component summary (PCS), the mental component summary (MCS), and the 8 domain scores range from zero (0) to 100, with higher scores representing higher level of functioning.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).","id":"OG000","title":"CyBorD"},{"description":"Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).","id":"OG001","title":"Daratumumab Plus CyBorD"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"The intent to treat analysis set included all randomized participants. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. Data for this outcome measure was planned to be collected and analyzed for specified arms only.","reportingStatus":"POSTED","timeFrame":"Baseline (Day -28), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96","title":"Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)","type":"SECONDARY","unitOfMeasure":"Score on scale"}