{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":".5","upperLimit":"5.17","value":"1.79"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"Tmax: time to maximum plasma concentration\n\nAnalysis of individual plasma concentration versus time profiles showed that at 6 hours post instillation, the plasma concentrations of all 6 patients were below 2 ng/mL, with the plasma concentration of one patient dropping below the LOQ (i.e., \\< 0.100 ng/mL).\n\nThe mean Cmax was 6.24 ng/mL (range: 2.43 to 12.80 ng/mL), and the Tmax was 1.79 hours (range: 0.50 to 5.17 hours) after instillation. The highest individual observed Cmax value of 12.80 ng/mL was 187-fold and 40 fold lower than the observed Cmax level following an intravenous bolus dose of 30 mg or 10 mg mitomycin (2.4 μg/mL and 0.52 μg/mL, respectively) and is 31 fold lower than the threshold value of 400 ng/mL for myelosuppression observed with mitomycin.","dispersionType":"Inter-Quartile Range","groups":[{"description":"The PK profiles of the first UGN-101 instillation in the blood were to be examined for the first 6 patients.","id":"OG000","title":"Pharmacokinetic Population"}],"paramType":"MEAN","populationDescription":"PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters.","reportingStatus":"POSTED","timeFrame":"Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation with UGN-101","title":"Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients.","type":"SECONDARY","unitOfMeasure":"Hours"}