{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"description":"Dose-limiting toxicities (DLTs) were determined during cycle 1 of the dose-escalation phase and defined as Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 grade 4 (life threatening requiring urgent intervention) or 5 (resulted in death) toxicity, excluding adverse events commonly caused by AML (eg, neutropenia, fever). Hematologic DLT was defined as failure of platelet recovery to 25 × 10\\^9/L or greater and absolute neutrophil count (ANC) to 0.5 × 10\\^9/L or greater within 14 days of the last dose of venetoclax in the absence of residual AML.","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.","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.","id":"OG001","title":"Phase 1: 800 mg Venetoclax + LDAC"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The DLT-evaluable population included participants who received at least 80% of planned Cycle 1 doses during the dose-escalation phase (Phase 1)","reportingStatus":"POSTED","timeFrame":"Up to 28 days (Cycle 1)","title":"Phase 1: Number of Participants With Dose-limiting Toxicities","type":"PRIMARY","unitOfMeasure":"Participants"}