{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"233"}]}],"title":"Adverse events (AEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"181"}]}],"title":"Adverse events Grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"118"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"35"}]}],"title":"AEs leading to discontinuation of carfilzomib"},{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"40"}]}],"title":"AEs leading to discontinuation of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"21"}]}],"title":"Fatal adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"180"}]}],"title":"Treatment-related adverse events (TRAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"108"}]}],"title":"Treatment-related adverse events Grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"57"}]}],"title":"Serious treatment-related adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"23"}]}],"title":"TRAE leading to discontinuation of carfilzomib"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"29"}]}],"title":"TRAEs leading to discontinuation of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"}]}],"title":"Fatal treatment-related adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"235"},{"groupId":"OG001","value":"238"}],"units":"Participants"}],"description":"The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal.\n\nTreatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship.","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":"OG000","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":"OG001","title":"Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants who received at least 1 dose of study drug","reportingStatus":"POSTED","timeFrame":"From first dose of study drug up to 30 days after last dose, up to the end of study; median (minimum, maximum) duration of treatment was 29.1 (0.1, 156.3) weeks and 38.0 (0.1, 158.3) weeks in each treatment group respectively.","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}