{"analyses":[{"ciLowerLimit":"3.48","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.51","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.773","groupDescription":"Treatment groups were compared using a linear mixed model for repeated measures (MMRM). The model included the fixed, categorical effects of treatment (all baseline responses were modeled with a dummy treatment), the randomization stratification factors - ISS stage, choice of route of bortezomib administration, region, age, and random effects of subject intercept and coefficient on time.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.0001","pValueComment":"Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.","paramType":"Least squares mean difference","paramValue":"4.99","statisticalMethod":"Mixed Effects Model for Repeated Measure"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.9","value":"53.3"},{"groupId":"OG001","spread":"22.5","value":"53.9"}]}],"title":"Baseline (n = 425, 425)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.5","value":"56.2"},{"groupId":"OG001","spread":"19.6","value":"61.1"}]}],"title":"Week 6 (n = 412, 407)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.8","value":"55.3"},{"groupId":"OG001","spread":"17.7","value":"62.4"}]}],"title":"Week 12 (n = 376, 389)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.8","value":"55.7"},{"groupId":"OG001","spread":"17.4","value":"63.2"}]}],"title":"Week 18 (n = 341, 369)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.6","value":"57.3"},{"groupId":"OG001","spread":"17.1","value":"63.3"}]}],"title":"Week 24 (n = 320, 345)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.8","value":"61.6"},{"groupId":"OG001","spread":"17.8","value":"63.0"}]}],"title":"Week 30 (n = 298, 317)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.5","value":"61.9"},{"groupId":"OG001","spread":"18.1","value":"64.0"}]}],"title":"Week 36 (n = 285, 308)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.7","value":"63.3"},{"groupId":"OG001","spread":"18.1","value":"65.0"}]}],"title":"Week 42 (n = 275, 288)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.4","value":"62.9"},{"groupId":"OG001","spread":"17.1","value":"65.1"}]}],"title":"Week 48 (n = 261, 265)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"478"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients.\n\nIt consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).\n\nThe EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG000","title":"Bortezomib, Melphalan, Prednisone"},{"description":"Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG001","title":"Carfilzomib, Melphalan, Prednisone"}],"paramType":"MEAN","populationDescription":"Intent-to treat population with available data at each time point.","reportingStatus":"POSTED","timeFrame":"Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48","title":"European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores","type":"SECONDARY","unitOfMeasure":"units on a scale"}