{"analyses":[{"ciLowerLimit":"92.66","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"105.6","estimateComment":"Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).","groupDescription":"MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727","groupIds":["OG000","OG001"],"nonInferiorityComment":"ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% confidence interval (CI) of the 5-day AUC0-24 ratio of Least Square Mean (LSM) for oral/IV was contained entirely within the range of 0.80 - 1.25.","nonInferiorityType":"EQUIVALENCE","paramType":"Ratio of Geometric LSM","paramValue":"98.93"},{"ciLowerLimit":"91.23","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"108.8","estimateComment":"Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).","groupDescription":"AML: IV Decitabine Versus AML: ASTX727","groupIds":["OG002","OG003"],"nonInferiorityComment":"ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-24 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.","nonInferiorityType":"EQUIVALENCE","paramType":"Ratio of Geometric LSM","paramValue":"99.64"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"40.0","value":"864.34"},{"groupId":"OG001","spread":"50.6","value":"855.96"},{"groupId":"OG002","spread":"52.4","value":"910.1"},{"groupId":"OG003","spread":"52.0","value":"900.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"123"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"69"}],"units":"Participants"}],"description":"Total 5-day ASTX727 AUC0-24 exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-24 (first ASTX727 dose) was added to (Day 2 AUC0-24+ Day 5 AUC0-24) × 2. Decitabine 5-day AUC0-24 exposures after IV decitabine were calculated as follows: (Day 1 AUC0-24+ Day 5 AUC0-24) / 2 was multiplied by 5. If AUC0-24 on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-24 on Day 5; the converse was also true.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).","id":"OG000","title":"MDS or CMML: IV Decitabine"},{"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 cycles 1 or 2 (each cycle = 28 days). 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":"OG001","title":"MDS or CMML: ASTX727"},{"description":"Participants with AML received IV infusion of decitabine 20 mg/m\\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).","id":"OG002","title":"AML: IV Decitabine"},{"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 cycles 1 or 2 (each cycle = 28 days). 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":"OG003","title":"AML: ASTX727"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Primary Endpoint Pharmacokinetics (PK) Analysis Set included participants who received full dose of ASTX727 within 3 hours of the intended dosing time, and no vomiting within 6 hours of dosing, and had at least 2 days of evaluable decitabine (AUC0-24) measurements in the ASTX727 cycle, i.e, Day 1 and either Day 2 or Day 5 and received the full IV decitabine dose as a 1-hour infusion.","reportingStatus":"POSTED","timeFrame":"ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days)","title":"Total 5-day Area Under the Curve From 0 to 24 Hours (AUC0-24) After Treatment With ASTX727 And IV Decitabine","type":"PRIMARY","unitOfMeasure":"hours*nanograms per milliliter (h*ng/mL)"}