{"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":"FG000","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":"FG001","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":"FG002","title":"Phase 2: 600 mg Venetoclax + LDAC"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"10"}],"type":"Adverse Event Not Related to Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"8"}],"type":"Adverse Event Related to Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"4"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"10"}],"type":"Progressive Disease with Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"20"}],"type":"Progressive Disease Without Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"7"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"15"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Did Not Receive Treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"76"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"74"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Indicates participants remaining on study","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"76"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"Previously untreated adults with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy were enrolled at nine study sites in the United States, Australia, Germany, and Italy between December 2014 and May 2017.\n\nThe study consisted of a dose escalation phase (Phase 1) to determine the recommended Phase 2 dose (RPTD), and a dose expansion phase (Phase 2)."}