{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"14"},{"groupId":"OG006","value":"4"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"2"}]}],"title":"Adverse event related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"3"}]}],"title":"Serious adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"1"}]}],"title":"Serious adverse event related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"3"}]}],"title":"Grade 3 or 4 adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"2"}]}],"title":"AE leading to study drug discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"1"}]}],"title":"AE leading to study drug interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"}]}],"title":"AE leading to a dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"3"}]}],"title":"AE leading to other action taken"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"1"}]}],"title":"Death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"14"},{"groupId":"OG006","value":"4"}],"units":"Participants"}],"description":"A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:\n\n* Results in death;\n* Is life threatening;\n* Requires inpatient hospitalization or prolongation of existing hospitalization;\n* Results in persistent or significant disability/incapacity;\n* Is a congenital anomaly/birth defect;\n* Is medically important.\n\nThe Investigator assessed each AE for potential causal relationship between the event and study drug.\n\nThe intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).","groups":[{"description":"Participants with normal renal function (defined as creatinine clearance \\> 80 mL/min/1.73m\\^2) received a single subcutaneous dose of azacitidine 25 mg/m\\^2 on Day 1.","id":"OG000","title":"Azacitidine 25 mg/m^2"},{"description":"Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\\^2 on Day 1.","id":"OG001","title":"Azacitidine 50 mg/m^2"},{"description":"Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\\^2 on Days 1 to 5.","id":"OG002","title":"Azacitidine 75 mg/m^2"},{"description":"Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\\^2 on Day 1.","id":"OG003","title":"Azacitidine 100 mg/m^2"},{"description":"Participants with severe renal impairment (RI; defined as creatinine clearance \\< 30 mL/min/1.73 m\\^2) received subcutaneous doses of azacitidine 75 mg/m\\^2 on Days 1 to 5.","id":"OG004","title":"Severe RI: Azacitidine 75 mg/m^2"},{"description":"Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\\^2 azacitidine daily on Days 1-7 of each 28-day cycle.","id":"OG005","title":"Extension Phase: Normal RF"},{"description":"Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\\^2 azacitidine daily on Days 1-7 of each 28-day cycle.","id":"OG006","title":"Extension Phase: Severe RI"}],"paramType":"NUMBER","populationDescription":"Safety population, all enrolled patients who received at least one dose of azacitidine and who had at least one post-treatment safety assessment.","reportingStatus":"POSTED","timeFrame":"Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).","title":"Number of Participants With Adverse Events (AEs)","type":"PRIMARY","unitOfMeasure":"participants"}