{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"34"},{"groupId":"OG004","value":"5"}]}],"title":">= 1 Treatment-emergent adverse event (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"18"},{"groupId":"OG004","value":"4"}]}],"title":">=1 Treatment-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"2"}]}],"title":">=1 Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"}]}],"title":">=1 Serious TEAE related to treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"2"}]}],"title":">=1 TEAE severity 3 or 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"}]}],"title":">=1 TEAE severity grade 3/4 related to treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":">=1 TEAE leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":">=1 TEAE leading to dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"1"}]}],"title":">=1 TEAE leading to dose interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"}]}],"title":">=1 TEAE leading to dose interruption + reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"2"}]}],"title":">= 1 TEAE leading to drug discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"35"},{"groupId":"OG004","value":"5"}],"units":"Participants"}],"description":"An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 42 days after the last dose. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to the study drug and reported as 'Suspected' on the CRF. AEs with a missing relationship were treated as 'treatment-related' in data summaries.","groups":[{"description":"Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.","id":"OG000","title":"Sotatercept 0.1 mg/kg"},{"description":"Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.","id":"OG001","title":"Sotatercept 0.3 mg/kg"},{"description":"Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.","id":"OG002","title":"Sotatercept 0.5 mg/kg"},{"description":"Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).","id":"OG003","title":"Sotatercept 1.0 mg/kg"},{"description":"Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.","id":"OG004","title":"Sotatercept 2.0 mg/kg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population: all participants who receive at least one dose of study medication.","reportingStatus":"POSTED","timeFrame":"Day 1 up to 59.2 months","title":"Participants With Treatment-Emergent Adverse Events (TEAE)","type":"SECONDARY","unitOfMeasure":"Participants"}