{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1044.2","value":"2.43"},{"groupId":"OG001","spread":"71.3","value":"-13.55"},{"groupId":"OG002","spread":"862.2","value":"9.32"},{"groupId":"OG003","spread":"270.8","value":"-7.28"},{"groupId":"OG004","spread":"127.7","value":"-16.61"},{"groupId":"OG005","spread":"95.3","value":"-11.92"},{"groupId":"OG006","spread":"92.0","value":"-17.79"},{"comment":"Could not be calculated when N = 1","groupId":"OG007","spread":"NA","value":"-8.92"},{"comment":"Could not be calculated when N = 1","groupId":"OG008","spread":"NA","value":"-16.14"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"56"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"1"}],"units":"Participants"}],"description":"The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma 2-HG was measured using qualified LC-MS/MS in order to characterize the pharmacodynamic (PD) effects of enasidenib; 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 a single oral dose of enasidenib 30 mg on Day -3.","id":"OG000","title":"Enasidenib 30 mg"},{"description":"Participants received a single oral dose of enasidenib 50 mg on Day -3.","id":"OG001","title":"Enasidenib 50 mg"},{"description":"Participants received a single oral dose of enasidenib 75 mg on Day -3.","id":"OG002","title":"Enasidenib 75 mg"},{"description":"Participants received a single oral dose of enasidenib 100 mg on Day -3.","id":"OG003","title":"Enasidenib 100 mg"},{"description":"Participants received a single oral dose of enasidenib 150 mg on Day -3.","id":"OG004","title":"Enasidenib 150 mg"},{"description":"Participants received a single oral dose of enasidenib 200 mg on Day -3.","id":"OG005","title":"Enasidenib 200 mg"},{"description":"Participants received a single oral dose of enasidenib 300 mg on Day -3.","id":"OG006","title":"Enasidenib 300 mg"},{"description":"Participants received a single oral dose of enasidenib 450 mg on Day -3.","id":"OG007","title":"Enasidenib 450 mg"},{"description":"Participants received a single oral dose of enasidenib 650 mg on Day -3.","id":"OG008","title":"Enasidenib 650 mg"}],"paramType":"MEAN","populationDescription":"Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PD parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.","reportingStatus":"POSTED","timeFrame":"Screening visit, Day -3 prior to the single dose of enasidenib and at 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 (%BAUEC0-10) of 2-hydroxyglutarate (2-HG) on Day -3","type":"SECONDARY","unitOfMeasure":"percent change"}