{"analyses":[{"ciLowerLimit":"1.86","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"25.30","estimateComment":"Non-inferiority difference, defined as p(MMB) - (0.8) \\*p(DAN) where p(MMB) is percentage of participants with TI status in MMB arm and p(DAN) is percentage of participants with TI status in DAN arm.","groupIds":["OG000","OG001"],"nonInferiorityComment":"If the lower bound of the confidence interval (CI) is greater than 0, MMB was to be declared non-inferior to DAN.","nonInferiorityType":"NON_INFERIORITY","pValue":"0.0116","paramType":"Non-inferiority difference","paramValue":"13.58","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.28","upperLimit":"38.66","value":"30.0"},{"groupId":"OG001","lowerLimit":"11.10","upperLimit":"31.77","value":"20.00"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"65"}],"units":"Participants"}],"description":"TI status was defined as not receiving red blood cell (RBC) or whole blood transfusion for \\>=12 weeks, with no hemoglobin (Hgb) level \\< 8 grams per deciliter (g/dL) during the same interval. Percentage of participants with TI have been presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.","id":"OG000","title":"MMB 200 mg QD + Placebo"},{"description":"Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.","id":"OG001","title":"DAN 300 mg BID + Placebo"}],"paramType":"NUMBER","populationDescription":"ITT Analysis Set","reportingStatus":"POSTED","timeFrame":"Week 24","title":"Percentage of Participants With Transfusion Independence (TI) at Week 24","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}