{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"219"},{"groupId":"OG001","value":"102"}]}],"title":"≥ 1 Treatment-emergent adverse event (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"8"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"19"}]}],"title":"Grade ≥ 3 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"31"}]}],"title":"Treatment-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"0"}]}],"title":"Treatment-related Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"1"}]}],"title":"Treatment-related TEAE ≥ Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"TEAE leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Trt-related TEAE leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"3"}]}],"title":"TEAE leading to dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"11"}]}],"title":"TEAE leading to dose delay"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"2"}]}],"title":"TEAE leading to drug discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"2"}]}],"title":"Trt-related TEAE leading to dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"3"}]}],"title":"Trt-related TEAE leading to dose delay"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"1"}]}],"title":"Trt-related TEAE leading to drug discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"109"}],"units":"Participants"}],"description":"An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. A serious AE is any AE occurring at any dose that - Results in death - Is life-threatening - Requires or prolongs existing inpatient hospitalization - Results in persistent or significant disability/incapacity - Is a congenital anomaly/birth defect - Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention) - Grade 3 = Severe (limitation in activity; medical intervention required) - Grade 4 = Life-threatening - Grade 5 = Death","groups":[{"description":"Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care","id":"OG000","title":"Luspatercept + BSC"},{"description":"Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care","id":"OG001","title":"Placebo + BSC"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All treated participants","reportingStatus":"POSTED","timeFrame":"From first dose to 90 days following last dose (up to approximately 52 months)","title":"Participants With Treatment-Emergent Adverse Events (TEAE)","type":"SECONDARY","unitOfMeasure":"Participants"}