{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Adverse events ≥ Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Leading to discontinuation of carfilzomib"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Leading to discontinuation of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Fatal adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Treatment-related adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Treatment-related adverse events ≥ Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Treatment-related serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Treatment-related fatal adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"Treatment-emergent adverse events are defined as any adverse event with an onset date from the first dose through 30 days after the last dose of any study drug.\n\nTreatment-emergent related adverse events are adverse events considered related to at least one study drug by the investigator.\n\nAdverse events were graded using Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03, where Grade 1: Mild (asymptomatic or mild symptoms) Grade 2: Moderate (minimal, local or noninvasive intervention indicated) Grade 3: Severe (severe) or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated) Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.","groups":[{"description":"Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12.\n\nParticipants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.","id":"OG000","title":"Carfilzomib Plus Dexamethasone"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All enrolled and treated participants","reportingStatus":"POSTED","timeFrame":"From the first dose of study drug until 30 days after the last dose (12 months)","title":"Number of Participants With Treatment-emergent Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}