{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.02","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"}],"title":"Complete/partial response"},{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"}],"title":"Minor response"},{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}],"title":"No response"},{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"}],"title":"Not evaluable"}]}],"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":"COUNT_OF_PARTICIPANTS","populationDescription":"Renal response in accordance with IMWG criteria was assessed in 20 patients with eGFR and creatinine clearance data recorded at screening and at the end of four cycles of trial treatment.","reportingStatus":"POSTED","timeFrame":"End of week 12 (after receiving 4 cycles of therapy)","title":"Number of Participants With Different Renal Responses to Treatment","type":"PRIMARY","unitOfMeasure":"Participants"}