{"analyses":[{"ciLowerLimit":"108.6","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"254.6","estimateComment":"Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.","groupDescription":"Comparison of AUC0-inf after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.\n\nGeometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Ratio (%) of Geometric Means","paramValue":"166.3"},{"ciLowerLimit":"92.2","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"216.2","estimateComment":"Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.","groupDescription":"Comparison of AUC0-inf after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.\n\nGeometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Ratio (%) of Geometric Means","paramValue":"141.2"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"39.05","value":"946.22"},{"groupId":"OG001","spread":"63.46","value":"1573.82"}]}],"title":"Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.94","value":"857.64"},{"groupId":"OG001","spread":"49.07","value":"1210.92"}]}],"title":"Day 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine, after a single dose (Day 1) and multiple doses (Day 5), calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation:\n\nAUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m\\^2 on Days 1 to 5.","id":"OG000","title":"Normal RF: Azacitidine 75 mg/m^2"},{"description":"Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m\\^2 on Days 1 to 5.","id":"OG001","title":"Severe RI: Azacitidine 75 mg/m^2"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.","reportingStatus":"POSTED","timeFrame":"Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose","title":"Area Under the Plasma Concentration-time Curve From Time 0 to Infinity After Single and Multiple Doses of Azacitidine","type":"PRIMARY","unitOfMeasure":"ng*hr/mL"}