{"analyses":[{"ciLowerLimit":"0","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"0.52","estimateComment":"Median difference is Severe RI - Normal RF.","groupDescription":"Comparison of Tmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1342","paramType":"Median Difference (Final Values)","paramValue":"0.25","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"ciLowerLimit":"0","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"0.50","estimateComment":"Median difference is Severe RI - Normal RF.","groupDescription":"Comparison of Tmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1017","paramType":"Median Difference (Final Values)","paramValue":"0.25","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.25","upperLimit":"0.50","value":"0.25"},{"groupId":"OG001","lowerLimit":"0.25","upperLimit":"1.50","value":"0.50"}]}],"title":"Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.25","upperLimit":"0.50","value":"0.38"},{"groupId":"OG001","lowerLimit":"0.25","upperLimit":"1.03","value":"0.64"}]}],"title":"Day 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment.","dispersionType":"Full Range","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":"MEDIAN","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":"Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine","type":"PRIMARY","unitOfMeasure":"hours"}