{"analyses":[{"ciLowerLimit":"0.96","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"18.79","groupDescription":"Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and 33% hematological improvement was achieved in the luspatercept group in outcome 2.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0402","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"Odds Ratio (OR)","paramValue":"4.24","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.1"},{"groupId":"OG001","value":"1.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"112"}],"units":"Participants"}],"description":"Percentage of participants who achieved a red blood cell (RBC) transfusion burden reduction from baseline ≥ 50% with a reduction of at least 2 units during Weeks 13 - 24 compared to the 12-week interval on or prior to Dose 1 Day 1.","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":"Baseline: Day -83 to Day 1; Treatment: Weeks 13 to Week 24","title":"Percentage Of Participants Who Achieve ≥ 50% Reduction From Baseline in Transfusion Burden - Week 13 to Week 24","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}