{"classes":[{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Encorafenib: Cycle 1 Day 1"},{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"LHY746: Cycle 1 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"37","value":"13000"},{"groupId":"OG001","spread":"28.1","value":"9170"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"title":"Encorafenib: Cycle 1 Day 15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"78.2","value":"8460"},{"groupId":"OG001","spread":"115","value":"7740"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"title":"LHY746: Cycle 1 Day 15"}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"AUCtau was area under the concentration-time profile from time zero to time tau, the dosing interval. tau = 24 hrs for QD dosing of encorafenib. LHY746 is a metabolite of encorafenib. AUCtau can be calculated directly from the data using 24 hrs (tau) sample or can be approximately calculated by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\\^2 IV bolus then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.","id":"OG000","title":"SLI: Cohort 1 [EC + FOLFIRI]"},{"description":"Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\\^2 IV bolus then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.","id":"OG001","title":"SLI: Cohort 2 [EC + mFOLFOX6]"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK parameter analysis set analyzed. Overall Number of Participants Analyzed: participants evaluable for the outcome measure and Number Analyzed: participants evaluable at specified timepoints. For Cohort 2, Number Analyzed=0 on Cycle 1 Day 1 indicated there was no PK sample at end of dosing interval and kel could not be reliably estimated for calculating AUCtau on specified timepoints. Cohort 1 participants didn't receive encorafenib till Cycle 1 Day 3, hence no analysis done at Cycle 1 Day 1.","reportingStatus":"POSTED","timeFrame":"Cohort 1: Pre-dose (0 hr), 0.75, 1.5, 2.5, 3.5, 5.5, 7.5, and 48 hrs post-dose on Day 15 of Cycle 1; Cohort 2: Pre-dose (0 hr), 1, 2, 3, 4, 6, 8, and 48 hrs post-dose on Days 1 and 15 of Cycle 1","title":"SLI: Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Encorafenib and Its Metabolite LHY746","type":"SECONDARY","unitOfMeasure":"Nanogram*hour per milliliter"}