{"denoms":[{"counts":[{"groupId":"BG000","value":"356"},{"groupId":"BG001","value":"350"},{"groupId":"BG002","value":"706"}],"units":"Participants"}],"groups":[{"description":"Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m\\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \\[IMWG\\] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab.","id":"BG000","title":"Velcade, Melphalan and Prednisone (VMP)"},{"description":"Participants received Velcade 1.3 mg/m\\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).","id":"BG001","title":"Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"5.82","value":"71.5"},{"groupId":"BG001","spread":"6.66","value":"71.3"},{"groupId":"BG002","spread":"6.25","value":"71.4"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"189"},{"groupId":"BG001","value":"190"},{"groupId":"BG002","value":"379"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"167"},{"groupId":"BG001","value":"160"},{"groupId":"BG002","value":"327"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"40"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"332"},{"groupId":"BG001","value":"320"},{"groupId":"BG002","value":"652"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"14"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"92"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"304"},{"groupId":"BG001","value":"297"},{"groupId":"BG002","value":"601"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}],"title":"Argentina"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"15"}]}],"title":"Australia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"14"}]}],"title":"Belgium"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}]}],"title":"Brazil"},{"categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"23"}]}],"title":"Bulgaria"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}],"title":"Croatia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"50"}]}],"title":"Czech Republic"},{"categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"22"}]}],"title":"Georgia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"}]}],"title":"Germany"},{"categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"29"}]}],"title":"Greece"},{"categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"26"}]}],"title":"Hungary"},{"categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"54"}]}],"title":"Italy"},{"categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"50"}]}],"title":"Japan"},{"categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"66"}]}],"title":"Poland"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]}],"title":"Portugal"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"11"}]}],"title":"Macedonia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"28"}]}],"title":"Romania"},{"categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"43"}]}],"title":"Russia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"10"}]}],"title":"Serbia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"41"}]}],"title":"Korea, Republic of"},{"categories":[{"measurements":[{"groupId":"BG000","value":"47"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"103"}]}],"title":"Spain"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"15"}]}],"title":"Turkey"},{"categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"48"}]}],"title":"Ukraine"},{"categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"24"}]}],"title":"United Kingdom"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]}],"title":"United States"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"67"},{"groupId":"BG001","value":"69"},{"groupId":"BG002","value":"136"}]}],"title":"Stage I"},{"categories":[{"measurements":[{"groupId":"BG000","value":"160"},{"groupId":"BG001","value":"139"},{"groupId":"BG002","value":"299"}]}],"title":"Stage II"},{"categories":[{"measurements":[{"groupId":"BG000","value":"129"},{"groupId":"BG001","value":"142"},{"groupId":"BG002","value":"271"}]}],"title":"Stage III"}],"description":"The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (\\<) 3.5 milligrams per liter (mg/L) and albumin greater than or equal to (\\>=) 3.5 grams per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin \\>= 5.5 mg/L.","paramType":"COUNT_OF_PARTICIPANTS","title":"Stage of Disease (ISS)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"1.737","value":"1.27"},{"groupId":"BG001","spread":"1.056","value":"1.09"},{"groupId":"BG002","spread":"1.442","value":"1.18"}]}]}],"description":"Time from multiple myeloma (MM) diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group.","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Time from multiple myeloma (MM) diagnosis","unitOfMeasure":"Months"}]}