{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"178"},{"groupId":"OG001","value":"165"}]}],"title":"One TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"36"}]}],"title":"One Suspected Related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"71"}]}],"title":"One Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}],"title":"One Suspected Related Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"88"}]}],"title":"NCI CTCAE Grade 3 or 4 TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"4"}]}],"title":"Suspected Related NCI CTCAE Grade 3 or 4 TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"14"}]}],"title":"NCI CTCAE Grade 5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Suspected Related NCI CTCAE Grade 5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"51"}]}],"title":"One TEAE Leading to Dose Interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"}]}],"title":"One TEAE Leading to Dose Reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"}]}],"title":"One TEAE Leading to Dose Withdrawn"}],"denoms":[{"counts":[{"groupId":"OG000","value":"182"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"description":"Treatment-emergent adverse events include adverse events that started on or after the first dose of treatment until 42 days after the last dose of treatment, as well as those serious adverse events (SAEs) made known to the investigator at any time thereafter that are suspected of being related to treatment.\n\nThe severity/intensity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0). Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.","groups":[{"description":"Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.","id":"OG000","title":"Luspatercept"},{"description":"Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).","id":"OG001","title":"Epoetin Alfa"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population - all participants who were randomized and received at least one dose of treatment.","reportingStatus":"POSTED","timeFrame":"From first dose to 42 days post last dose (Up to approximately an average of 72 weeks and a maximum of 208 weeks)","title":"The Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}