{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.2","upperLimit":"5.2","value":"3.3"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"4.2","value":"3.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"157"}],"units":"Participants"}],"description":"Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). 1 or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).","dispersionType":"95% Confidence Interval","groups":[{"description":"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).\n\nOptional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle).","id":"OG000","title":"Best Supportive Care"},{"description":"Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \\[Days 1, 2, 8, 9, 15, 16\\] for individual subjects).","id":"OG001","title":"Carfilzomib"}],"paramType":"MEDIAN","populationDescription":"The intent to treat (ITT) analysis set comprised all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.","title":"Progression-free Survival","type":"SECONDARY","unitOfMeasure":"months"}