{"analyses":[{"ciLowerLimit":"-1.10","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.51","estimateComment":"luspatercept - placebo","groupDescription":"Change from baseline at Week 48 P-value ANCOVA model with geographical regions defined at randomization and baseline LIC as covariates. LS = least square","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7598","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"LS Mean of Difference","paramValue":"0.20","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.770","value":"0.05"},{"groupId":"OG001","spread":"5.329","value":"-0.00"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"99"}],"units":"Participants"}],"description":"Baseline was defined as the last value on or before the first dose of study drug was administered; if multiple values were present for the same date, the average of these values was used. If a participant had 1 postbaseline assessment, it was used as the Week 48 value. If a participant had multiple postbaseline assessments, the last one was used as the Week 48 value. The value of LIC was collected by magnetic resonance imaging. Participants with a LIC value \\> 43 mg/g were not included in the analysis.","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: Week -12 to Day -1; Treatment: Week 48","title":"Mean Change From Baseline In Liver Iron Concentration (LIC) At Week 48","type":"SECONDARY","unitOfMeasure":"mg/g dry weight"}