{"analyses":[{"ciLowerLimit":"1.21","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.12","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0010","paramType":"Odds Ratio (OR)","paramValue":"1.6","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"157"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"542"},{"groupId":"OG001","value":"543"}],"units":"Participants"}],"description":"Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT.\n\nAccording to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and \\< 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.","groups":[{"description":"Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)\n\nBortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD): Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation","id":"OG000","title":"Arm A Part 1"},{"description":"Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab\n\nBortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab: Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation","id":"OG001","title":"Arm B Part 1"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants randomized in the first randomization.","reportingStatus":"POSTED","timeFrame":"At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT","title":"Post-Consolidation Stringent Complete Response (sCR) Rate","type":"PRIMARY","unitOfMeasure":"Participants"}