{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"19"},{"groupId":"OG005","value":"50"},{"groupId":"OG006","value":"30"}],"units":"Participants"}],"description":"Hematological improvement was calculated as defined by the IWG 2006 MDS Response Criteria.","groups":[{"description":"Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).\n\nASTX727 Dose Escalation: Oral investigational product and approved IV decitabine","id":"OG000","title":"Phase 1 Dose Escalation Cohort 1"},{"description":"Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).\n\nASTX727 Dose Escalation: Oral investigational product and approved IV decitabine","id":"OG001","title":"Phase 1 Dose Escalation Cohort 2"},{"description":"Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).\n\nASTX727 Dose Escalation: Oral investigational product and approved IV decitabine","id":"OG002","title":"Phase 1 Dose Escalation Cohort 3"},{"description":"Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).\n\nASTX727 Dose Escalation: Oral investigational product and approved IV decitabine","id":"OG003","title":"Phase 1 Dose Escalation Cohort 4"},{"description":"Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).\n\nASTX727 Dose Escalation: Oral investigational product and approved IV decitabine","id":"OG004","title":"Phase 1 Dose Escalation Cohort 5"},{"description":"Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.","id":"OG005","title":"Phase 2 Dose Confirmation"},{"description":"Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.","id":"OG006","title":"Phase 2 Fixed-Dose Combination"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The efficacy population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product.","reportingStatus":"POSTED","timeFrame":"Up to 32 months","title":"Number of Participants With Hematological Improvement","type":"SECONDARY","unitOfMeasure":"Participants"}