{"analyses":[{"ciLowerLimit":"73.2","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"274.6","estimateComment":"Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.","groupDescription":"Comparison of Cmax 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":"141.7"},{"ciLowerLimit":"54.5","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"204.6","estimateComment":"Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.","groupDescription":"Comparison of Cmax 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":"105.6"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"57.90","value":"745.50"},{"groupId":"OG001","spread":"93.01","value":"1056.66"}]}],"title":"Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"45.86","value":"632.56"},{"groupId":"OG001","spread":"91.64","value":"668.11"}]}],"title":"Day 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"The maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and for participants with severe renal impairment.","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":"Maximum Plasma Concentration of Azacitidine (Cmax) After Single and Multiple Doses of Azacitidine","type":"PRIMARY","unitOfMeasure":"ng/mL"}