{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"82.10","upperLimit":"106.50","value":"93.52"},{"groupId":"OG001","lowerLimit":"80.48","upperLimit":"118.30","value":"97.59"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"24"}],"units":"Participants"}],"description":"Decitabine 5-day AUC ratio following IV decitabine 20 mg/m\\^2 infusion versus concomitant oral administration of decitabine + cedazuridine (E7727) or ASTX727 in the dose combination and fixed-dose combination stages, respectively. AUC0-t (the area under the concentration-time curve from time zero to the time of the last (tlast) quantifiable concentration (Ct)) by dose/cohort and course/days was used for estimating decitabine cumulative 5-day AUC0-t exposures.","dispersionType":"80% Confidence Interval","groups":[{"description":"Participants were randomized in a 1:1 ratio to receive either Sequence A: Oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\\^2) Dailyx5 in Course 2; or Sequence B: IV decitabine (20 mg/m\\^2) Dailyx5 in Course 1 followed by cedazuridine + decitabine capsules Dailyx5 in Course 2 (28 days per course). 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":"OG000","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":"OG001","title":"Phase 2 Fixed-Dose Combination"}],"paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","populationDescription":"Participants with evaluable PK measurements are included. Phase 2 crossover design was used to compare AUC ratio for oral and IV administration.","reportingStatus":"POSTED","timeFrame":"Pre-dose to Day 5","title":"Mean Decitabine Area Under the Plasma Concentration Versus Time Curve Ratio (5-day AUC0-t) in Phase 2","type":"PRIMARY","unitOfMeasure":"Ratio of Geometric LSM"}