{"denoms":[{"counts":[{"groupId":"BG000","value":"465"},{"groupId":"BG001","value":"464"},{"groupId":"BG002","value":"929"}],"units":"Participants"}],"groups":[{"description":"Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.","id":"BG000","title":"Bortezomib + DEX"},{"description":"Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.","id":"BG001","title":"Carfilzomib + DEX"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"30.0","upperLimit":"88.0","value":"65.0"},{"groupId":"BG001","lowerLimit":"35.0","upperLimit":"89.0","value":"65.0"},{"groupId":"BG002","lowerLimit":"30.0","upperLimit":"89.0","value":"65.0"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"210"},{"groupId":"BG001","value":"223"},{"groupId":"BG002","value":"433"}],"title":"< 65 years"},{"measurements":[{"groupId":"BG000","value":"189"},{"groupId":"BG001","value":"164"},{"groupId":"BG002","value":"353"}],"title":"65 -74 years"},{"measurements":[{"groupId":"BG000","value":"66"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"143"}],"title":"≥ 75 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"236"},{"groupId":"BG001","value":"224"},{"groupId":"BG002","value":"460"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"229"},{"groupId":"BG001","value":"240"},{"groupId":"BG002","value":"469"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"353"},{"groupId":"BG001","value":"348"},{"groupId":"BG002","value":"701"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"17"}],"title":"Black"},{"measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"113"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}],"title":"Native Hawaiian/Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"95"}],"title":"Not Reported"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"Multiple"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"232"},{"groupId":"BG001","value":"221"},{"groupId":"BG002","value":"453"}],"title":"0 (Fully active)"},{"measurements":[{"groupId":"BG000","value":"203"},{"groupId":"BG001","value":"211"},{"groupId":"BG002","value":"414"}],"title":"1 (Restrictive but ambulatory)"},{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"62"}],"title":"2 (Ambulatory but unable to work)"}]}],"description":"Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active; 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, no self-care, 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":"253"},{"groupId":"BG001","value":"252"},{"groupId":"BG002","value":"505"}],"title":"Carfilzomib or bortezomib"},{"measurements":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"212"},{"groupId":"BG002","value":"424"}],"title":"No prior carfilzomib or bortezomib"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Stratification Factor: Prior Proteasome Inhibitor Treatment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"229"},{"groupId":"BG001","value":"231"},{"groupId":"BG002","value":"460"}],"title":"1 line"},{"measurements":[{"groupId":"BG000","value":"236"},{"groupId":"BG001","value":"233"},{"groupId":"BG002","value":"469"}],"title":"2 or 3 lines"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Stratification Factor: Lines of Prior Treatment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"204"},{"groupId":"BG001","value":"205"},{"groupId":"BG002","value":"409"}],"title":"Stage I"},{"measurements":[{"groupId":"BG000","value":"261"},{"groupId":"BG001","value":"259"},{"groupId":"BG002","value":"520"}],"title":"Stage II or III"}]}],"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":"108"},{"groupId":"BG001","value":"108"},{"groupId":"BG002","value":"216"}],"title":"Intravenous"},{"measurements":[{"groupId":"BG000","value":"357"},{"groupId":"BG001","value":"356"},{"groupId":"BG002","value":"713"}],"title":"Subcutaneous"}]}],"description":"The route of bortezomib administration (IV versus SC) was made in accordance with local regulatory approved route of administration. The value for this variable was selected for all participants prior to randomization to treatment group in order to balance the baseline characteristics that led to the choice of the particular route of bortezomib administration between the 2 arms.","paramType":"COUNT_OF_PARTICIPANTS","title":"Stratification Factor: Route of Bortezomib Administration","unitOfMeasure":"Participants"}],"populationDescription":"Intent-to-treat population (all randomized participants)"}