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6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.68","value":"69.33"},{"groupId":"OG001","spread":"16.59","value":"65.73"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"223"}],"units":"Participants"}],"title":"Cycle 7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.82","value":"69.44"},{"groupId":"OG001","spread":"16.64","value":"66.34"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"206"}],"units":"Participants"}],"title":"Cycle 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.90","value":"65.72"},{"groupId":"OG001","spread":"15.53","value":"67.82"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"202"}],"units":"Participants"}],"title":"Cycle 9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.56","value":"68.38"},{"groupId":"OG001","spread":"16.26","value":"67.98"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"197"}],"units":"Participants"}],"title":"Cycle 10"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.24","value":"67.42"},{"groupId":"OG001","spread":"17.37","value":"68.52"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"189"}],"units":"Participants"}],"title":"Cycle 11"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.94","value":"65.13"},{"groupId":"OG001","spread":"17.16","value":"67.47"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"187"}],"units":"Participants"}],"title":"Cycle 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.51","value":"67.49"},{"groupId":"OG001","spread":"18.21","value":"67.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"175"}],"units":"Participants"}],"title":"Cycle 13"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.03","value":"67.66"},{"groupId":"OG001","spread":"16.60","value":"66.12"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"169"}],"units":"Participants"}],"title":"Cycle 14"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.31","value":"69.34"},{"groupId":"OG001","spread":"17.68","value":"67.61"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"167"}],"units":"Participants"}],"title":"Cycle 15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.44","value":"68.21"},{"groupId":"OG001","spread":"18.69","value":"66.41"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"165"}],"units":"Participants"}],"title":"Cycle 16"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.92","value":"69.44"},{"groupId":"OG001","spread":"15.28","value":"69.81"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"159"}],"units":"Participants"}],"title":"Cycle 17"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.50","value":"66.67"},{"groupId":"OG001","spread":"16.38","value":"66.29"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"155"}],"units":"Participants"}],"title":"Cycle 18"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.50","value":"69.68"},{"groupId":"OG001","spread":"17.33","value":"68.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"150"}],"units":"Participants"}],"title":"Cycle 19"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.49","value":"71.04"},{"groupId":"OG001","spread":"19.52","value":"66.43"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"141"}],"units":"Participants"}],"title":"Cycle 20"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.87","value":"70.94"},{"groupId":"OG001","spread":"16.25","value":"67.42"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"143"}],"units":"Participants"}],"title":"Cycle 21"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.30","value":"68.52"},{"groupId":"OG001","spread":"17.90","value":"67.51"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"139"}],"units":"Participants"}],"title":"Cycle 22"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.41","value":"69.52"},{"groupId":"OG001","spread":"17.63","value":"66.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"131"}],"units":"Participants"}],"title":"Cycle 23"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.24","value":"68.10"},{"groupId":"OG001","spread":"16.51","value":"68.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"125"}],"units":"Participants"}],"title":"Cycle 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.15","value":"67.93"},{"groupId":"OG001","spread":"16.78","value":"66.21"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"127"}],"units":"Participants"}],"title":"Cycle 25"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.65","value":"70.71"},{"groupId":"OG001","spread":"17.54","value":"66.12"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"121"}],"units":"Participants"}],"title":"Cycle 26"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.78","value":"65.23"},{"groupId":"OG001","spread":"18.35","value":"66.52"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"112"}],"units":"Participants"}],"title":"Cycle 27"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.61","value":"63.22"},{"groupId":"OG001","spread":"18.66","value":"67.28"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"109"}],"units":"Participants"}],"title":"Cycle 28"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.25","value":"66.67"},{"groupId":"OG001","spread":"18.10","value":"67.22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"105"}],"units":"Participants"}],"title":"Cycle 29"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.63","value":"67.01"},{"groupId":"OG001","spread":"18.52","value":"67.23"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"104"}],"units":"Participants"}],"title":"Cycle 30"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.24","value":"68.06"},{"groupId":"OG001","spread":"18.81","value":"67.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"101"}],"units":"Participants"}],"title":"Cycle 31"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.62","value":"66.67"},{"groupId":"OG001","spread":"18.45","value":"67.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"title":"Cycle 32"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.35","value":"67.75"},{"groupId":"OG001","spread":"18.92","value":"67.95"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"91"}],"units":"Participants"}],"title":"Cycle 33"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.78","value":"68.18"},{"groupId":"OG001","spread":"17.77","value":"69.86"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"86"}],"units":"Participants"}],"title":"Cycle 34"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.62","value":"65.91"},{"groupId":"OG001","spread":"18.00","value":"69.51"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Cycle 35"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.22","value":"63.77"},{"groupId":"OG001","spread":"16.93","value":"68.22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"86"}],"units":"Participants"}],"title":"Cycle 36"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.91","value":"67.50"},{"groupId":"OG001","spread":"19.01","value":"68.63"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"title":"Cycle 37"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.69","value":"65.20"},{"groupId":"OG001","spread":"18.47","value":"69.25"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"84"}],"units":"Participants"}],"title":"Cycle 38"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.46","value":"64.71"},{"groupId":"OG001","spread":"19.15","value":"68.38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"78"}],"units":"Participants"}],"title":"Cycle 39"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.25","value":"58.33"},{"groupId":"OG001","spread":"19.34","value":"67.74"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"78"}],"units":"Participants"}],"title":"Cycle 40"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.26","value":"66.07"},{"groupId":"OG001","spread":"19.37","value":"68.46"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"79"}],"units":"Participants"}],"title":"Cycle 41"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.19","value":"63.69"},{"groupId":"OG001","spread":"18.77","value":"67.16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"68"}],"units":"Participants"}],"title":"Cycle 42"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.89","value":"67.22"},{"groupId":"OG001","spread":"19.91","value":"63.30"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"57"}],"units":"Participants"}],"title":"Cycle 43"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.27","value":"61.81"},{"groupId":"OG001","spread":"18.21","value":"65.50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"50"}],"units":"Participants"}],"title":"Cycle 44"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.11","value":"67.59"},{"groupId":"OG001","spread":"15.53","value":"66.87"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"title":"Cycle 45"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.91","value":"64.58"},{"groupId":"OG001","spread":"17.66","value":"67.89"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"34"}],"units":"Participants"}],"title":"Cycle 46"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.00","value":"66.67"},{"groupId":"OG001","spread":"13.74","value":"68.52"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"title":"Cycle 47"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.62","value":"61.11"},{"groupId":"OG001","spread":"13.35","value":"68.56"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Cycle 48"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.62","value":"61.11"},{"groupId":"OG001","spread":"13.49","value":"68.42"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"Cycle 49"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.62","value":"61.11"},{"groupId":"OG001","spread":"13.09","value":"68.75"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"16"}],"units":"Participants"}],"title":"Cycle 50"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.81","value":"63.89"},{"groupId":"OG001","spread":"11.49","value":"67.36"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"title":"Cycle 51"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.68","value":"54.17"},{"groupId":"OG001","spread":"17.24","value":"62.04"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Cycle 52"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"9.62","value":"61.11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"title":"Cycle 53"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.04","value":"61.00"},{"groupId":"OG001","spread":"18.02","value":"59.90"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"title":"Follow-up"}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"312"}],"units":"Participants"}],"description":"Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.\n\nQLQ-C30 questionnaire was administered prior to dosing every 28 ± 7 days starting from cycle 1 day 1 through first follow-up visit (30 days \\[+3\\] after last dose of all study drugs).","dispersionType":"Standard Deviation","groups":[{"description":"Carfilzomib was administered intravenously (IV) at 20 mg/m\\^2 in Cycle 1: days 1 and 2; at 56 mg/m\\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.\n\nDexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.","id":"OG000","title":"Kd - Carfilzomib and Dexamethasone"},{"description":"Carfilzomib was administered intravenously (IV) at 20 mg/m\\^2 in Cycle 1: days 1 and 2; at 56 mg/m\\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.\n\nDexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.\n\nDaratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.","id":"OG001","title":"KdD - Carfilzomib, Dexamethasone and Daratumumab"}],"paramType":"MEAN","populationDescription":"Intent to Treat Population","reportingStatus":"POSTED","timeFrame":"Baseline (Day 1 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO)","title":"Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose","type":"SECONDARY","unitOfMeasure":"score on a scale"}