{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.47","upperLimit":"3.00","value":"1.00"},{"groupId":"OG001","lowerLimit":"0.47","upperLimit":"2.12","value":"0.95"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"29"}],"units":"Participants"}],"description":"Tmax is the time to reach maximum plasma concentration for decitabine. PK parameters for plasma decitabine are reported for the dose confirmation and fixed-dose combination stages.","dispersionType":"Full Range","groups":[{"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":"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":"MEDIAN","populationDescription":"Participants with evaluable PK measurements are included.","reportingStatus":"POSTED","timeFrame":"At specific timepoints from 0 to 24 hours post-dose","title":"Time to Maximum Observed Plasma Concentration (Tmax) of Decitabine in Phase 2","type":"SECONDARY","unitOfMeasure":"hours"}