{"analyses":[{"ciLowerLimit":"1.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.5","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","paramType":"Odds Ratio (OR)","paramValue":"2.8","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"67.2","upperLimit":"80.4","value":"74.2"},{"groupId":"OG001","lowerLimit":"45.5","upperLimit":"60.5","value":"53.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"182"},{"groupId":"OG001","value":"181"}],"units":"Participants"}],"description":"The percentage of participants meeting the modified HI-E criteria per the International Working Group (IWG) sustained over any consecutive 56-day period in Week 1-24: For participants with baseline red blood cell (RBC) transfusion burden of \\>= 4 units/8 weeks, a reduction of at least 4 units RBC transfusion; for participants with baseline RBC transfusion burden of \\< 4 units/8 weeks, mean increase of hemoglobin of at least 1.5 g/dL in the absence of transfusions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.","id":"OG000","title":"Luspatercept"},{"description":"Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).","id":"OG001","title":"Epoetin Alfa"}],"paramType":"NUMBER","populationDescription":"ITT Population - all randomized participants regardless of whether or not the participant received treatment.","reportingStatus":"POSTED","timeFrame":"Week 1 through Week 24","title":"Percentage of Participants Achieving Hematologic Improvement - Erythroid Response (HI-E) Per IWG","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}