{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20"}]}],"title":"At least one Treatment Emergent AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}],"title":"At least one TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}],"title":"At least one Grade 3-4 adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"At least 1 Grade 3-4 TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"At least 1 Grade 5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"At least 1 Grade 5 TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"At least 1 serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"At least 1 serious TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"At least one serious Grade 3-4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"TEAE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Study drug-related TEAE leading to discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"TEAE leading to study drug dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"TEAE leading to study drug dose interruption only"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"TEAE causing study dose reduction/interruption"}],"denomUnitsSelected":"participants","denoms":[{"counts":[{"groupId":"OG000","value":"22"}],"units":"Participants"}],"description":"AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death","groups":[{"description":"Azacitidine 75 mg/m2/day by subcutaneous injection \\[SC\\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.","id":"OG000","title":"Azacitidine (AZA)"}],"paramType":"NUMBER","populationDescription":"Safety population includes those enrolled in the extension phase who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days","title":"Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)","type":"SECONDARY","typeUnitsAnalyzed":"participants","unitOfMeasure":"participants"}