{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"74"}]}],"title":"Any treatment-emergent adverse event (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"72"}]}],"title":"TEAE with CTCAE Grade 3 or 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"72"}]}],"title":"TEAE with CTCAE Grade 3 or above"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"66"}]}],"title":"Venetoclax-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"71"}]}],"title":"LDAC-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"64"}]}],"title":"TEAE leading to hospitalization"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"24"}]}],"title":"TEAE leading to venetoclax discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"26"}]}],"title":"TEAE leading to LDAC discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"45"}]}],"title":"TEAE leading to venetoclax interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"38"}]}],"title":"TEAE leading to LDAC interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"6"}]}],"title":"TEAE leading to venetoclax reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"TEAE leading to LDAC reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"15"}]}],"title":"TEAE leading to death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"74"}],"units":"Participants"}],"description":"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator rated the severity of each AE according to the CTCAE Version 4.0 and the following:\n\nGrade 1: The AE is transient and easily tolerated (mild).\n\nGrade 2: The AE causes discomfort and interrupts usual activities (moderate).\n\nGrade 3: The AE causes considerable interference with usual activities and may be incapacitating (moderate to severe).\n\nGrade 4: The AE is life threatening requiring urgent intervention.\n\nGrade 5: The AE resulted in death.\n\nThe investigator assessed each event as either having a reasonable possibility or no reasonable possibility of being related to the use of study drug.\n\nTreatment-emergent events are defined as events that began or worsened in severity after the first dose of study drug.","groups":[{"description":"Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.\n\nParticipants could continue receiving treatment until disease progression or until discontinuation criteria were met.","id":"OG000","title":"Phase 1: 600 mg Venetoclax + LDAC"},{"description":"Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.\n\nParticipants could continue receiving treatment until disease progression or until discontinuation criteria were met.","id":"OG001","title":"Phase 1: 800 mg Venetoclax + LDAC"},{"description":"Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.\n\nParticipants could continue receiving treatment until disease progression or until discontinuation criteria were met.","id":"OG002","title":"Phase 2: 600 mg Venetoclax + LDAC"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All enrolled participants who received at least one dose of study drug","reportingStatus":"POSTED","timeFrame":"From first dose of study drug until 30 days after last dose of study drug; median (minimum, maximum) duration of treatment was 4.1 (0.2, 62.8) months overall.","title":"Number of Participants With Treatment-emergent Adverse Events (TEAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}