{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"82.9","value":"4830"},{"groupId":"OG001","spread":"46.8","value":"9437"},{"groupId":"OG002","spread":"60.0","value":"9002"},{"comment":"Percent coefficient of variation could not be calculated due to small sample size","groupId":"OG003","spread":"NA","value":"13463"},{"groupId":"OG004","spread":"16.1","value":"20705"},{"groupId":"OG005","spread":"132.7","value":"6502"},{"groupId":"OG006","spread":"80.6","value":"3954"},{"groupId":"OG007","spread":"42.0","value":"9502"},{"groupId":"OG008","spread":"40.1","value":"13263"},{"groupId":"OG009","spread":"47.2","value":"14303"},{"groupId":"OG010","spread":"35.0","value":"12448"},{"groupId":"OG011","spread":"18.7","value":"17963"},{"comment":"Percent coefficient of variation could not be calculated due to small sample size","groupId":"OG012","spread":"NA","value":"22102"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"94"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"11"},{"groupId":"OG010","value":"7"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"2"}],"units":"Participants"}],"description":"AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 10 hours post-dose (AUC0-10) was calculated using the linear trapezoidal rule.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received enasidenib 30 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG000","title":"Enasidenib 30 mg BID"},{"description":"Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG001","title":"Enasidenib 50 mg BID"},{"description":"Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG002","title":"Enasidenib 75 mg BID"},{"description":"Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity","id":"OG003","title":"Enasidenib 100 mg BID"},{"description":"Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG004","title":"Enasidenib 150 mg BID"},{"description":"Participants received enasidenib 50 mg tablets every day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG005","title":"Enasidenib 50 mg QD"},{"description":"Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG006","title":"Phase 1 Dose Escalation: Enasidenib 75 mg QD"},{"description":"Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG007","title":"Phase 1 Dose Escalation: Enasidenib 100 mg QD"},{"description":"Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG008","title":"Phase 1 Dose Escalation: Enasidenib 150 mg QD"},{"description":"Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG009","title":"Phase 1 Dose Escalation: Enasidenib 200 mg QD"},{"description":"Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG010","title":"Phase 1 Dose Escalation: Enasidenib 300 mg QD"},{"description":"Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG011","title":"Phase 1 Dose Escalation: Enasidenib 450 mg QD"},{"description":"Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG012","title":"Phase 1 Dose Escalation: Enasidenib 650 mg QD"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.","reportingStatus":"POSTED","timeFrame":"Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.","title":"Phase 1: AUC From Time Zero to 10 Hours Postdose (AUC0-10) of AGI-16903 After Multiple Oral Doses of Enasidenib","type":"SECONDARY","unitOfMeasure":"ng*h/mL"}