{"analyses":[{"ciLowerLimit":"7.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"26.4","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0007","paramType":"Rate Difference","paramValue":"17.0","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":"16.2","upperLimit":"32.4","value":"24.3"},{"groupId":"OG001","lowerLimit":"2.4","upperLimit":"12.2","value":"7.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"109"}],"units":"Participants"}],"description":"HI-P response was defined according to IWG 2006 criteria (Cheson, 2006) and as: 1. Absolute increase of ≥ 30 X 10\\^9/L for participants\\^ starting with \\> 20 X 10\\^9/L platelets; 2. Increase from \\< 20 X 10\\^9/L to \\> 20 X 10\\^9/L and by at least 100%. HI-P must have lasted at least 8 weeks.","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 a Hematological Improvement Response in Platelets (HI-P) According to 2006 IWG Criteria","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}