{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"235"},{"groupId":"OG001","value":"233"}]}],"title":"≥ 1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"121"}]}],"title":"≥ 1 TEAE Related to Study Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"109"}]}],"title":"≥ 1 Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"5"}]}],"title":"≥ 1 Treatment Related Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"201"}]}],"title":"≥ 1 Grade 3/4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"55"}]}],"title":"≥ 1 Treatment Related Grade 3/4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}]}],"title":"≥ 1 TEAE Leading to Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"6"}]}],"title":"≥ 1 TEAE Leading to Dose Reduction (Red)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"43"}]}],"title":"≥ 1 TEAE Leading to Dose Interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"3"}]}],"title":"≥ 1 TEAE Leading to Dose Red and Interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"170"}]}],"title":"≥ 1 TEAE Leading to Study Drug Discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"236"},{"groupId":"OG001","value":"233"}],"units":"Participants"}],"description":"TEAEs include AEs that started between first dose date and 28 days after the last dose of study drug. A serious adverse event (SAE) is: • Death • Life-threatening event • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly or birth defect • Other important medical event The severity of AEs were assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0: Grade 1 (Mild): asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Grade 4: Life-threatening; urgent intervention indicated. Grade 5: Death due to AE.","groups":[{"description":"Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.","id":"OG000","title":"Oral Azacitidine Plus Best Supportive Care"},{"description":"Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.","id":"OG001","title":"Placebo Plus Best Supportive Care"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population included all randomized participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}