{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"48.9","value":"-62.18"},{"groupId":"OG001","spread":"113.1","value":"-62.60"},{"groupId":"OG002","spread":"21.4","value":"-87.19"},{"groupId":"OG003","spread":"14.2","value":"-84.24"},{"groupId":"OG004","spread":"13.7","value":"-79.40"},{"groupId":"OG005","spread":"44.9","value":"-58.76"},{"groupId":"OG006","spread":"38.8","value":"-69.00"},{"groupId":"OG007","spread":"80.3","value":"-64.23"},{"groupId":"OG008","spread":"72.6","value":"-71.67"},{"groupId":"OG009","spread":"34.1","value":"-79.34"},{"groupId":"OG010","spread":"5.7","value":"-87.74"},{"groupId":"OG011","spread":"48.8","value":"-62.89"},{"comment":"Could not be calculated for N = 1","groupId":"OG012","spread":"NA","value":"2.54"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"77"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"10"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"1"}],"units":"Participants"}],"title":"Cycle 1, Day 15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"115.4","value":"-49.01"},{"groupId":"OG001","spread":"430.9","value":"-35.49"},{"groupId":"OG002","spread":"74.7","value":"-64.63"},{"groupId":"OG003","spread":"19.0","value":"-83.93"},{"groupId":"OG004","spread":"17.2","value":"-78.07"},{"groupId":"OG005","spread":"25.9","value":"-81.51"},{"groupId":"OG006","spread":"70.5","value":"-66.41"},{"groupId":"OG007","spread":"190.7","value":"-53.46"},{"groupId":"OG008","spread":"317.5","value":"-37.70"},{"groupId":"OG009","spread":"599.5","value":"-27.70"},{"groupId":"OG010","spread":"9.4","value":"-87.88"},{"groupId":"OG011","spread":"40.2","value":"-76.98"},{"groupId":"OG012","spread":"24.9","value":"-82.28"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"89"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"8"},{"groupId":"OG010","value":"7"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"2"}],"units":"Participants"}],"title":"Cycle 2, Day 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"89"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"10"},{"groupId":"OG010","value":"7"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"2"}],"units":"Participants"}],"description":"Plasma 2-HG was measured using qualified LC-MS/MS, the LLOQ was 30.0 ng/mL. Area under the effect concentration time curve from time point zero (predose) up to 10 hours postdose (AUEC0-10) was calculated using the linear trapezoid rule. Percent change from baseline for AUEC0-10 was calculated as: (AUEC0-10 minus \\[Baseline\\*Tlast\\]) / (Baseline\\*Tlast) \\* 100, where Tlast corresponded to 10 hours and Baseline was equal to the average of the Screening and Day -3 (predose) 2-HG values. Data reported are the arithmetic mean and relative standard deviation expressed as a percentage.","dispersionType":"Standard Deviation","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":"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 1, Day 15 and Cycle 2, Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.","title":"Phase 1: Percent Change From Baseline for Area Under the Effect Concentration Time Curve From Time 0 to 10 Hours Postdose of 2-HG After Multiple Oral Doses of Enasidenib","type":"SECONDARY","unitOfMeasure":"percent change"}