{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"19"}],"units":"Participants"}],"description":"Number of participants with protocol-specified dose-limiting toxicities (DLTs) in the dose escalation stage. DLTs were defined using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAEv4.0), specifically ≥ Grade 3 non-hematologic toxicity (except Grade 3 nausea, vomiting, or diarrhea that is controllable by anti-emetics or optimal therapy or related to underlying disease or disease progression), specific Grade 3 laboratory tests, related prolonged Grade 4 thrombocytopenia or neutropenia that was not present prior to dosing, does not resolve within 14 days, and is not related to underlying disease, or any toxicity related to study treatment that results in treatment delays of \\>4 weeks after Day 28.","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).","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).","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).","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).","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).","id":"OG004","title":"Phase 1 Dose Escalation Cohort 5"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population includes participants in Phase 1 who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"Up to Day 28 in Course 1 (28 days per course)","title":"Number of Participants With Dose-limiting Toxicity in Phase 1","type":"PRIMARY","unitOfMeasure":"Participants"}