{"analyses":[{"ciLowerLimit":"-1.76","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.93","estimateComment":"luspatercept - placebo","groupDescription":"Change from baseline at Week 48 LSM = least squares mean","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"LSM Difference","paramValue":"-1.34","statisticalComment":"Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline transfusion burden as covariates.","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.792","value":"-0.67"},{"groupId":"OG001","spread":"1.774","value":"0.66"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"102"}],"units":"Participants"}],"description":"Baseline was defined as the total number of Red Blood Cells (RBC) units transfused during the 12-week interval on or prior to Dose 1 Day 1. This is compared to the total number of RBC units transfused during the 12-week interval from treatment weeks 13-24.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"All randomized participants with available measurements at the specified timepoints","reportingStatus":"POSTED","timeFrame":"Baseline: Day -83 to Day 1; Treatment: Weeks 13 to Week 24","title":"Mean Change From Baseline in Transfusion Burden - Week 13 to Week 24","type":"SECONDARY","unitOfMeasure":"RBC units"}