{"analyses":[{"ciLowerLimit":"-185.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"49.7","estimateComment":"luspatercept - placebo","groupDescription":"Deferasirox: Change from baseline at Week 48 LS = least squares","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2552","pValueComment":"Significance level of 0.050 for 2-sided tests","paramType":"LS Mean of Difference","paramValue":"-68.0","statisticalComment":"Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-612.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"460.1","estimateComment":"luspatercept - placebo","groupDescription":"Deferiprone: Change from baseline at Week 48 LS = least squares","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7746","pValueComment":"Significance level of 0.050 for 2-sided tests","paramType":"LS Mean of Difference","paramValue":"-76.4","statisticalComment":"Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-673.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"378.5","estimateComment":"luspatercept - placebo","groupDescription":"Deferoxamine Mesilate / Deferoxamine: Change from baseline at Week 48 LS = least squares","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5186","pValueComment":"Significance level of 0.050 for 2-sided tests","paramType":"LS Mean of Difference","paramValue":"-147.3","statisticalComment":"Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"378.67","value":"-105.0"},{"groupId":"OG001","spread":"297.11","value":"-60.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"title":"Deferasirox"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"893.62","value":"-229.1"},{"groupId":"OG001","spread":"614.80","value":"-73.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"title":"Deferiprone"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"523.45","value":"84.9"},{"groupId":"OG001","spread":"613.05","value":"274.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"Deferoxamine Mesilate/Deferoxamine"}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"66"}],"units":"Participants"}],"description":"Three different types of Iron Chelation Therapy (ICT) were analyzed: 1. Deferasirox 2. Deferiprone 3. Deferoxamine Mesilate/Deferoxamine The baseline mean daily dose was calculated using the ICT dosage during the 12 weeks prior to first study drug administration and the postbaseline mean daily dose was calculated during the last 12 weeks of the 48-week double-blind Treatment Period or the last 12 weeks of the study treatment for early discontinued participants.","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 Daily Dose Of Iron Chelation Therapies (ICT) At Week 48","type":"SECONDARY","unitOfMeasure":"mg"}