{"analyses":[{"ciLowerLimit":"2.17","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"14.53","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":"<0.0001","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"Odds Ratio (OR)","paramValue":"5.62","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"10.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"23.1","estimateComment":"Luspatercept - Placebo","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in Percentages","paramValue":"16.5"},{"ciLowerLimit":"9.9","ciPctValue":"95","ciUpperLimit":"23.1","estimateComment":"Luspatercept - Placebo","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Common Risk Difference","paramValue":"16.5"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.0"},{"groupId":"OG001","value":"4.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"112"}],"units":"Participants"}],"description":"Erythroid Response was defined as red blood cell (RBC) transfusion burden reduction from baseline ≥ 33% with a reduction of at least 2 units during Week 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 Achieved Erythroid Response - Week 13 to Week 24","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}