{"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"2","upperLimit":"44","value":"24.0"},{"groupId":"OG002","lowerLimit":"1","upperLimit":"2","value":"1.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"86","value":"1.0"},{"groupId":"OG004","lowerLimit":"9","upperLimit":"87","value":"48"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"21"},{"groupId":"OG004","value":"2"}],"units":"Participants"}],"title":"All participants"},{"categories":[{"measurements":[{"groupId":"OG002","lowerLimit":"1","upperLimit":"1","value":"1.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"52","value":"1.0"},{"groupId":"OG004","lowerLimit":"9","upperLimit":"9","value":"9.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"NTDE subpopulation"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"2","upperLimit":"44","value":"24.0"},{"groupId":"OG002","lowerLimit":"1","upperLimit":"2","value":"1.5"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"86","value":"1.5"},{"groupId":"OG004","lowerLimit":"87","upperLimit":"87","value":"87"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"16"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"TDE subpopulation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"21"},{"groupId":"OG004","value":"2"}],"units":"Participants"}],"description":"Time to first response = start date of first response (HI-E) - first dose date + 1 day. For NTDE participants (who required \\< 4 units of RBCs in the 8 weeks prior to start of therapy), HI-E was defined as an increase of \\>=1.5 g/dL hemoglobin sustained for 56 days over a period of \\>=8 weeks. For TDE participants (who required \\>=4 units of RBCs in the 8 weeks prior to start of therapy), HI-E was defined as a decrease of \\>= 4 units of RBCs transfused sustained for 56 days over a period of 8 weeks.","dispersionType":"Full Range","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":"MEDIAN","populationDescription":"Efficacy Evaluable Population of participants who responded","reportingStatus":"POSTED","timeFrame":"Day 1 to Day 87","title":"Time to Erythroid Hematological Improvement (HI-E) Response","type":"SECONDARY","unitOfMeasure":"days"}