{"analyses":[{"ciLowerLimit":"-2.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"23.7","groupIds":["OG000","OG001"],"nonInferiorityComment":"HI-E","nonInferiorityType":"SUPERIORITY","pValue":"0.1467","paramType":"Rate Difference","paramValue":"10.9","statisticalComment":"Stratified by average BL RBC tfx needs: ≤4 units versus \\>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2","statisticalMethod":"Stratified Mantel-Haenszel. Chi-squared"},{"ciLowerLimit":"8.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"26.9","groupIds":["OG000","OG001"],"nonInferiorityComment":"≥ 1.5 g/dL Hemoglobin Increase","nonInferiorityType":"SUPERIORITY","pValue":"0.0002","paramType":"Rate Diffrence","paramValue":"17.9","statisticalComment":"Stratified by average BL RBC tfx needs: ≤4 units versus \\>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2","statisticalMethod":"Stratified Mantel-Haenszel. Chi-squared"},{"ciLowerLimit":"-1.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"23.6","groupIds":["OG000","OG001"],"nonInferiorityComment":"RBC Transfusion Reduction","nonInferiorityType":"SUPERIORITY","pValue":"0.1431","paramType":"Rate Difference","paramValue":"10.9","statisticalComment":"Stratified by average BL RBC tfx needs: ≤4 units versus \\>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2","statisticalMethod":"Stratified Mantel-Haenszel. Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"33.6","upperLimit":"52.4","value":"43.0"},{"groupId":"OG001","lowerLimit":"23.3","upperLimit":"40.9","value":"32.1"}]}],"title":"HI-E Response"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.3","upperLimit":"31.4","value":"23.4"},{"groupId":"OG001","lowerLimit":"1.2","upperLimit":"9.8","value":"5.5"}]}],"title":"≥ 1.5 g/dL Hemoglobin Increase"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"32.7","upperLimit":"51.4","value":"42.1"},{"groupId":"OG001","lowerLimit":"22.5","upperLimit":"39.9","value":"31.2"}]}],"title":"RBC Transfusion Reduction"}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"109"}],"units":"Participants"}],"description":"Erythroid HI-E improvement was defined as a hemoglobin increase of ≥ 1.5 g/dL; or a reduction in units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a hemoglobin of ≤ 9.0 g/dL on treatment were counted in the RBC transfusion response evaluation.","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 included 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 With an Erythroid Hematological Improvement (HI-E) Response According to 2006 IWG Criteria","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}