{"analyses":[{"groupDescription":"Statistical analysis of SAEs.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"=0.48","statisticalMethod":"Fisher Exact"},{"groupDescription":"Statistical analysis of AEs","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"=0.25","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"}]}],"title":"Adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"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":"NUMBER","reportingStatus":"POSTED","timeFrame":"End of weeks 3, 6, 9, 12 (after receiving 4 cycles of therapy), 30 days after final treatment and 12 months after randomisation","title":"Haematological and Non-haematological Toxicity in Both Treatment Arms","type":"SECONDARY","unitOfMeasure":"Events"}