{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"101","upperLimit":"130","value":"129"},{"groupId":"OG001","lowerLimit":"135","upperLimit":"245","value":"149"},{"groupId":"OG002","lowerLimit":"158","upperLimit":"204","value":"181"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"2"}],"units":"Participants"}],"description":"Cmax was defined as the maximum observed concentration of denileukin diftitox following administration of study treatment on Cycle 1 Day 1 and was obtained directly from the measured serum concentration-time curves. Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a lower limit of quantitation (LLOQ) of 30 nanograms per milliliter (ng/mL). Serum pharmacokinetic (PK) data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the median and full range for all participants and expressed as ng/mL.","dispersionType":"Full Range","groups":[{"description":"Denileukin diftitox (6 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).","id":"OG000","title":"Cohort 1: 6 ug/kg/Day Denileukin Diftitox"},{"description":"Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).","id":"OG001","title":"Cohort 2: 9 ug/kg/Day Denileukin Diftitox"},{"description":"Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).","id":"OG002","title":"Cohort 3: 12 ug/kg/Day Denileukin Diftitox"}],"paramType":"MEDIAN","populationDescription":"PK analysis set included all participants in whom at least one PK parameter could be calculated.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (Day 1)","title":"Maximum Serum Concentration (Cmax) of Denileukin Diftitox","type":"SECONDARY","unitOfMeasure":"ng/mL"}