{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1074.93","upperLimit":"2669.08","value":"1872"},{"groupId":"OG001","lowerLimit":"2663.49","upperLimit":"2663.49","value":"2663.49"},{"groupId":"OG002","lowerLimit":"2084.81","upperLimit":"2084.81","value":"2084.81"},{"groupId":"OG003","lowerLimit":"3021.81","upperLimit":"8906.31","value":"7431.06"},{"groupId":"OG004","lowerLimit":"4724.92","upperLimit":"10910.87","value":"5655.05"},{"comment":"No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.","groupId":"OG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"1"}],"units":"Participants"}],"description":"Steady State AUC for lorlatinib in patients in cohort A1 and B1","dispersionType":"Full Range","groups":[{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"OG000","title":"Cohort A1 DL1"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"OG001","title":"Cohort A1 DL2"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"OG002","title":"Cohort A1 DL3"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"OG003","title":"Cohort A1 DL4"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"OG004","title":"Cohort A1 DL5"},{"description":"Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.\n\nLorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.","id":"OG005","title":"Cohort B1 DL5"}],"paramType":"MEDIAN","populationDescription":"No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.","reportingStatus":"POSTED","timeFrame":"Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose)","title":"Pharmacokinetics A1 and B1-Steady State AUC","type":"SECONDARY","unitOfMeasure":"hours*ng/mL"}