{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"454"},{"groupId":"OG001","value":"460"}]}],"title":"All adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"354"}]}],"title":"AEs ≥ grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"235"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"83"}]}],"title":"Leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"31"}]}],"title":"Fatal adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"431"},{"groupId":"OG001","value":"408"}]}],"title":"Treatment-related adverse events (TRAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"268"}]}],"title":"TRAEs ≥ grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"136"}]}],"title":"Treatment-related serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"54"}]}],"title":"TRAE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"10"}]}],"title":"Treatment-related fatal adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"470"},{"groupId":"OG001","value":"474"}],"units":"Participants"}],"description":"Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal.\n\nA serious adverse event is an adverse event that met 1 or more of the following criteria:\n\n* Death\n* Life-threatening\n* Required inpatient hospitalization or prolongation of an existing hospitalization\n* Resulted in persistent or significant disability/incapacity\n* Congenital anomaly/birth defect\n* Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above.\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 bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG000","title":"Bortezomib, Melphalan, Prednisone"},{"description":"Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG001","title":"Carfilzomib, Melphalan, Prednisone"}],"paramType":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}