{"analyses":[{"groupDescription":"Week 1 -24","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Cochran-Mantel-Haenszel"},{"groupDescription":"Week 1 - 48","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"44.72","upperLimit":"61.05","value":"52.9"},{"groupId":"OG001","lowerLimit":"5.56","upperLimit":"21.29","value":"11.8"}]}],"title":"Week 1 Through Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"50.59","upperLimit":"66.71","value":"58.8"},{"groupId":"OG001","lowerLimit":"9.43","upperLimit":"27.47","value":"17.1"}]}],"title":"Week 1 Through Week 48"}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"76"}],"units":"Participants"}],"description":"A modified HI-E response was defined as the percentage of participants meeting the modified HI-E per the International Working Group (IWG) sustained over 56-day consecutive period during the Treatment period. For participants with a baseline RBC transfusion burden of ≥ 4 units/8 weeks, a mHI-E was defined as a reduction in RBC transfusion of at least 4 units/8 weeks; for participants with baseline RBC transfusion burden of \\<4 units/8 weeks, mHI-E, was defined as a mean increase in hemoglobin of ≥ 1.5 g/dL for 8 weeks in the absence of RBC transfusions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle","id":"OG000","title":"Luspatercept"},{"description":"Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"All treated participants","reportingStatus":"POSTED","timeFrame":"Week 1 through 24 or Week 1 Through Week 48","title":"Percentage of Participants Who Achieved a Modified Hematologic Erythroid Response (mHI-E) Over Any Consecutive 56-Day Period","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}