{"analyses":[{"ciLowerLimit":"-4.48","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.04","estimateComment":"luspatercept - placebo","groupDescription":"Change from baseline at Week 48 LS = least square","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0543","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"LS Mean of Difference","paramValue":"-2.22","statisticalComment":"Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline myocardial T2\\* as covariates.","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.084","value":"-1.83"},{"groupId":"OG001","spread":"6.780","value":"-0.01"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"102"}],"units":"Participants"}],"description":"Myocardial Iron levels were measured by Magnetic Resonance Imaging (MRI), using MRI parameter T2\\* (Unit: ms). T2\\* values correlates with heart failure (HF) risk (e.g. T2\\*\\<6ms: high HF risk).","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 1; Treatment: Week 48","title":"Mean Change From Baseline In Myocardial Iron At Week 48","type":"SECONDARY","unitOfMeasure":"ms"}