{"analyses":[{"ciLowerLimit":"2.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.8","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","paramType":"Odds Ratio (OR)","paramValue":"3.1","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"52.9","upperLimit":"67.6","value":"60.4"},{"groupId":"OG001","lowerLimit":"27.9","upperLimit":"42.2","value":"34.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"182"},{"groupId":"OG001","value":"181"}],"units":"Participants"}],"description":"Percentage of participants who are RBC transfusion-free for any 12-week period associated with a concurrent mean hemoglobin (Hgb) increase ≥ 1.5 g/dL compared to baseline.\n\nAfter applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated.\n\n4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being \\< 14 days after the previous transfusion.","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 With Red Blood Cell Transfusion Independence (RBC-TI) for 12 Weeks (84 Days) With a Mean Hemoglobin Increase ≥ 1.5 g/dL","type":"PRIMARY","unitOfMeasure":"Percent of participants"}