{"analyses":[{"ciLowerLimit":"11.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"31.3","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"2 sided","paramType":"Rate Difference","paramValue":"21.6","statisticalComment":"Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \\>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \\&ECOG PS: 0 to 1 vs 2","statisticalMethod":"Stratified Mantel-Haenszel; Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"19.5","upperLimit":"36.5","value":"28.0"},{"groupId":"OG001","lowerLimit":"1.8","upperLimit":"11.0","value":"6.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"109"}],"units":"Participants"}],"description":"RBC transfusion independence was defined as the absence of any red blood cell (RBC) transfusion during any consecutive \"rolling\" 84 days within the treatment period. Participants who did not receive any RBC transfusion during a consecutive rolling 84 days (i.e., day 1 to day 84, day 2 to day 85) were considered as a 84-day RBC transfusion independent responder.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell \\[pRBC\\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.","id":"OG000","title":"Oral Azacitidine and Best Supportive Care"},{"description":"Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.","id":"OG001","title":"Placebo Plus Best Supportive Care"}],"paramType":"NUMBER","populationDescription":"The ITT population includes all participants who were randomized, regardless of whether they received treatment or not.","reportingStatus":"POSTED","timeFrame":"From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo","title":"Percentage of Participants Who Achieved RBC Transfusion Independence for ≥ 84 Days","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}