{"groups":[{"description":"Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.","id":"FG000","title":"MDS or CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727"},{"description":"Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.","id":"FG001","title":"MDS or CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727"},{"description":"Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.","id":"FG002","title":"AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727"},{"description":"Participants with AML received IV infusion of decitabine 20 mg/m\\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.","id":"FG003","title":"AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"25"},{"groupId":"FG002","numSubjects":"34"},{"groupId":"FG003","numSubjects":"34"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"8"}],"type":"Complete Consent Withdrawal"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"2"}],"type":"Rollover to ASTX727-06"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"1"}],"type":"Study Centre Terminated by Sponsor"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"69"},{"groupId":"FG001","numSubjects":"69"},{"groupId":"FG002","numSubjects":"44"},{"groupId":"FG003","numSubjects":"45"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"67"},{"groupId":"FG002","numSubjects":"43"},{"groupId":"FG003","numSubjects":"44"}],"comment":"The Safety Analysis Set included all participants who received any amount of study treatment.","type":"Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"69"},{"groupId":"FG001","numSubjects":"69"},{"groupId":"FG002","numSubjects":"44"},{"groupId":"FG003","numSubjects":"45"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 138 participants with a diagnosis of MDS or CMML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner. A total of 89 participants with a diagnosis of AML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner.","recruitmentDetails":"A total of 227 participants took part in the study from 15 February 2018 to 25 May 2023. 138 participants with a diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) took part from the United States and Canada. 89 participants with a diagnosis of acute myeloid leukemia (AML) took part from Austria, Canada, Czech Republic, France, Germany, Hungary, Italy, Spain, and United Kingdom."}