{"analyses":[{"ciLowerLimit":"-123.63","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-10.91","estimateComment":"luspatercept - placebo","groupDescription":"≥ 33% Transfusion Burden Reduction","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0195","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"Mean Difference (Final Values)","paramValue":"-67.27","statisticalMethod":"t-test, 2 sided"},{"ciLowerLimit":"-144.87","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"201.34","estimateComment":"luspatercept - placebo","groupDescription":"≥ 50% Transfusion Burden Reduction","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7473","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"Mean Difference (Final Values)","paramValue":"28.24","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"163.92","value":"96.3"},{"groupId":"OG001","spread":"148.78","value":"163.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"173"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"title":"≥ 33% Transfusion Burden Reduction"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"257.69","value":"189.1"},{"groupId":"OG001","spread":"160.17","value":"160.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"≥ 50% Transfusion Burden Reduction"}],"denoms":[{"counts":[{"groupId":"OG000","value":"173"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"description":"Time to erythroid response was defined as the time from first dose of the study drug to first erythroid response. This is reported for participants with a ≥ 33% reduction from baseline in RBC transfusion burden (with a reduction of at least 2 units) for any 12-week interval., as well as participants with a ≥ 50% reduction from baseline in RBC transfusion burden (with a reduction of at least 2 units) for any 12-week interval.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"All randomized participants who achieved erythroid response","reportingStatus":"POSTED","timeFrame":"From first dose to 48 weeks following first dose","title":"Time to Erythroid Response","type":"SECONDARY","unitOfMeasure":"Days"}