{"analyses":[{"ciLowerLimit":"1.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"32.9","groupDescription":"Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0015","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"Odds Ratio (OR)","paramValue":"7.6","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.1"},{"groupId":"OG001","value":"1.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"112"}],"units":"Participants"}],"description":"Transfusion independence was defined as the absence of any transfusion during any consecutive \"rolling\" 8-week time interval within the treatment period, i.e, Days 1 to 56, Days 2 to 57 and so on.","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":"NUMBER","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From first dose through 3 weeks post last dose (up to approximately 218 weeks)","title":"Percentage Of Participants Who Were Transfusion Independent For ≥ 8 Weeks During Treatment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}