{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"108"}]}],"title":"≥ 1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"54"}]}],"title":"≥ 1 TEAE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"69"}]}],"title":"≥ 1 Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"8"}]}],"title":"≥ 1 Serious TEAE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"81"}]}],"title":"≥ 1 Grade (GR) 3-4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"20"}]}],"title":"≥ 1 Grade 3-4 TEAE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"56"}]}],"title":"≥ 1 Grade (GR) 3-4 Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"5"}]}],"title":"≥ 1 GR 3-4 Serious TEAE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"14"}]}],"title":"≥ 1 TEAE Leading to Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"2"}]}],"title":"≥ 1 TEAE Related to Study Drug Leading to Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"4"}]}],"title":"≥ 1 TEAE Leading to Dose Reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"40"}]}],"title":"≥ 1 TEAE Leading to Dose Interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"2"}]}],"title":"≥ 1 TEAE Leading to Dose Interruption/Reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"31"}]}],"title":"≥ 1 TEAE Leading to Treatment Discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"109"}],"units":"Participants"}],"description":"A TEAE was defined as an adverse event that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug. A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population includes all randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From first dose of IP up to 28 days after the last dose of IP or until the last study visit; up to a maximum of approximately 6 months on study","title":"Number of Participants With Treatment Emergent Adverse Events (TEAE)","type":"SECONDARY","unitOfMeasure":"Participants"}