{"denoms":[{"counts":[{"groupId":"BG000","value":"238"},{"groupId":"BG001","value":"240"},{"groupId":"BG002","value":"478"}],"units":"Participants"}],"groups":[{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).\n\nParticipants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"BG000","title":"Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone"},{"description":"Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).\n\nParticipants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"BG001","title":"Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"35","upperLimit":"83","value":"66.0"},{"groupId":"BG001","lowerLimit":"39","upperLimit":"85","value":"66.0"},{"groupId":"BG002","lowerLimit":"35","upperLimit":"85","value":"66.0"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"104"},{"groupId":"BG001","value":"104"},{"groupId":"BG002","value":"208"}],"title":"18 - 64 years"},{"measurements":[{"groupId":"BG000","value":"102"},{"groupId":"BG001","value":"90"},{"groupId":"BG002","value":"192"}],"title":"65 - 74 years"},{"measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"77"}],"title":"75 - 84 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"≥ 85 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"110"},{"groupId":"BG001","value":"108"},{"groupId":"BG002","value":"218"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"132"},{"groupId":"BG002","value":"260"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"7"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"226"},{"groupId":"BG001","value":"235"},{"groupId":"BG002","value":"461"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"10"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"45"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"202"},{"groupId":"BG001","value":"200"},{"groupId":"BG002","value":"402"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"13"}],"title":"Other"},{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"13"}],"title":"Missing"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"118"},{"groupId":"BG001","value":"118"},{"groupId":"BG002","value":"236"}],"title":"0 (Fully active)"},{"measurements":[{"groupId":"BG000","value":"120"},{"groupId":"BG001","value":"121"},{"groupId":"BG002","value":"241"}],"title":"1 (Restrictive but ambulatory)"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"2 (Ambulatory but unable to work)"}]}],"description":"A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"100"},{"groupId":"BG001","value":"100"},{"groupId":"BG002","value":"200"}],"title":"Stage 1"},{"measurements":[{"groupId":"BG000","value":"138"},{"groupId":"BG001","value":"140"},{"groupId":"BG002","value":"278"}],"title":"Stage 2 or 3"}]}],"description":"The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group:\n\n* Stage I: β2-microglobulin (β2M) \\< 3.5 mg/L, albumin \\>= 3.5 g/dL\n* Stage II: β2M \\< 3.5 mg/L and albumin \\< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin\n* Stage III: β2M ≥ 5.5 mg/L","paramType":"COUNT_OF_PARTICIPANTS","title":"Stratification Factor: International Staging System (ISS) stage","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"176"}],"title":"Yes"},{"measurements":[{"groupId":"BG000","value":"150"},{"groupId":"BG001","value":"152"},{"groupId":"BG002","value":"302"}],"title":"No"}]}],"description":"Participants were classified as refractory to bortezomib in prior regimens if the data collected on prior multiple myeloma therapy indicated that any of the following criteria were met:\n\n1. Best Response to any regimen containing bortezomib was stable disease or progressive disease.\n2. Reason bortezomib was stopped was progression in any regimen.\n3. Date of relapse/progression was after start date and within 60 days after stop date of bortezomib in any regimen.","paramType":"COUNT_OF_PARTICIPANTS","title":"Stratification Factor: Refractory to Bortezomib Treatment","unitOfMeasure":"Participants"}],"populationDescription":"The intention-to-treat population consisted of all randomly assigned participants."}