{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"175"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"44"},{"groupId":"OG003","value":"19"}]}],"title":"Patients with >=1 treatment emergent AE (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"19"}]}],"title":"Patients with >=1 treatment related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"27"},{"groupId":"OG003","value":"14"}]}],"title":"Patients with >=1 serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"13"}]}],"title":"Patients with >=1 serious treatment related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"2"}]}],"title":"Patients w TEAE leading to discontinued treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"}]}],"title":"Patients w TEAE leading to dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"0"}]}],"title":"Patients w TEAE leading to dose interruption"}],"denoms":[{"counts":[{"groupId":"OG000","value":"175"},{"groupId":"OG001","value":"102"},{"groupId":"OG002","value":"44"},{"groupId":"OG003","value":"19"}],"units":"Participants"}],"description":"Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months). The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.","groups":[{"description":"Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.","id":"OG000","title":"Azacitidine"},{"description":"Care can include transfusions, antibiotics, myeloid growth factors \\[G-CSF and GM CSF\\] for neutropenic infections until the end of the study.","id":"OG001","title":"Best Supportive Care Only"},{"description":"Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.","id":"OG002","title":"Low-dose Cytarabine"},{"description":"Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.","id":"OG003","title":"Standard Chemotherapy"}],"paramType":"NUMBER","populationDescription":"Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.","reportingStatus":"POSTED","timeFrame":"Day 1 (randomization) to 42 months","title":"Number of Participants in Different Categories of Adverse Experiences During Core Study Period","type":"SECONDARY","unitOfMeasure":"participants"}