{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.198","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"6.3"}]}],"title":"Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14.8"},{"groupId":"OG001","value":"25.3"}]}],"title":"No Change"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9.9"},{"groupId":"OG001","value":"8.4"}]}],"title":"Worsened by 1 Level"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9.9"},{"groupId":"OG001","value":"12.6"}]}],"title":"Worsened by 2 Levels"},{"categories":[{"measurements":[{"groupId":"OG000","value":"63.0"},{"groupId":"OG001","value":"47.4"}]}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"95"}],"units":"Participants"}],"description":"The distribution (frequency and percentage) of the observed responses (i.e., \"Not at all (0),\" \"A little bit (1),\" \"Somewhat (2),\" \"Quite a bit (3),\" \"Very much (4),\" and missing) to Item GP-5 (\"I am bothered by side effects of treatment\" in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved \\[i.e., change score from 1 to 4\\], no change \\[0\\], worsened by one level \\[-1\\], worsened by ≥2 levels \\[-2 to -4\\], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group.","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 HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.","reportingStatus":"POSTED","timeFrame":"From Baseline to End of Treatment","title":"Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - End of Treatment","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}