{"analyses":[{"ciLowerLimit":"-498.30","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-186.87","estimateComment":"luspatercept - placebo","groupDescription":"Change from baseline at Week 48 LS = least squares","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Significance level of 0.050 for 2-sided tests","paramType":"LS Mean of Difference","paramValue":"-342.59","statisticalComment":"Estimates based on an ANCOVA model with geographical regions defined at randomization and baseline serum ferritin as covariates.","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"713.767","value":"-247.19"},{"groupId":"OG001","spread":"522.047","value":"100.38"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"101"}],"units":"Participants"}],"description":"For each participant, the baseline mean serum ferritin level was calculated during the 12 weeks prior to first study drug administration. The postbaseline mean serum ferritin level was calculated during the last 12 weeks of the 48-week double-blind Treatment Period or last 12 weeks of study treatment, if discontinued early. The change was calculated as the difference of post baseline mean serum ferritin level and baseline mean serum ferritin level.","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: Week 37 to Week 48","title":"Mean Change From Baseline In Mean Serum Ferritin At Week 48","type":"SECONDARY","unitOfMeasure":"μg/L"}