{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"19"},{"groupId":"OG004","value":"2"}]}],"title":"1. Increase to >= 140 mmHg systolic"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"}]}],"title":"2. Increase to >=90 mmHg diastolic"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"2"}]}],"title":"3. =140 systolic and increase > 20 mmHg base"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"}]}],"title":"4. >=90 mmHg diastolic and increase > 20 mmHg base"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}]}],"title":"5. Introduction of new anti-hypertension med"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":"6. Incre in dose of baseline anti-hypertension med"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"1"}]}],"title":"7.>= Grade 2 hypertension TEAE"}],"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":"The following were DLTs if the investigator suspected they were treatment related: 1. Increase to \\>= 140 mmHg systolic blood pressure 2. Increase to \\>=90 mmHg diastolic blood pressure 3. Increase to \\>=140 systolic and increase \\> 20 mmHg compared to baseline systolic 4. Increase to \\>=90 mmHg diastolic and increase \\> 20 mmHg compared to baseline diastolic 5. Introduction of new anti-hypertension medication during treatment 6. Increase in dose of baseline anti-hypertension medication during treatment 7. \\>= Grade 2 (moderate severity or worse) hypertension as an adverse event","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","reportingStatus":"POSTED","timeFrame":"Day 1 to 59.2 months","title":"Dose Limiting Toxicities (DLTs)","type":"SECONDARY","unitOfMeasure":"Participants"}