{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.33","statisticalMethod":"t-test, 1 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.15","value":"0.72"},{"groupId":"OG001","spread":"0.35","value":"0.69"}]}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.19","value":"0.69"},{"groupId":"OG001","spread":"0.28","value":"0.80"}]}],"title":"1 month FU"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"description":"The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on a scale of 1 to 3: 1 (no problems), 2 (some problems), and 3 (extreme problems). Higher score equates to a worse outcome.\n\nAs stated in the official EQ-5D user guide, patient responses to the 5 questions were converted into a single index value as per Dolan P (1997). Modeling valuations for EuroQol health states. Med Care 35(11):1095-108. These index values, with country specific value sets, facilitate the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions. In the UK, the values range from -0.594 to +1.","dispersionType":"Standard Deviation","groups":[{"description":"Bortezomib, Bendamustine and Dexamethasone\n\nBortezomib: 1.3 mg/m2 subcutaneously\\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).\n\n\\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib\n\nBendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)\n\nDexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle","id":"OG000","title":"Arm A (BBD)"},{"description":"Thalidomide, Bendamustine and Dexamethasone\n\nThalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)\n\nBendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)\n\nDexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle","id":"OG001","title":"Arm B (BTD)"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"Baseline and 1 month follow up","title":"Quality of Life Measured by the EQ-5D-3L Questionnaire at Baseline and 1 Month Follow up","type":"SECONDARY","unitOfMeasure":"Units on a scale"}