{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"43.9","value":"-36.9"},{"groupId":"OG001","spread":"63.9","value":"-37.7"},{"groupId":"OG002","spread":"96.4","value":"-38.6"},{"groupId":"OG003","spread":"53.1","value":"-47.5"},{"groupId":"OG004","spread":"44.5","value":"-59.6"},{"groupId":"OG005","spread":"37.5","value":"-56.9"},{"groupId":"OG006","spread":"9.0","value":"-74.7"},{"groupId":"OG007","spread":"38.6","value":"-31.5"},{"comment":"Could not be calculated for N = 1","groupId":"OG008","spread":"NA","value":"-36.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"57"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"2"},{"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. Minimum percent change from Baseline response value post-dose over 10 hours was calculated as: (minimum observed concentration post-dose over 10 hours \\[Rmin\\] - Baseline) / Baseline \\* 100. 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 Dose 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: Minimum Percent Change From Baseline Response Value Post-dose Over 10 Hours (%BRmin) for 2-HG After a Single Oral Dose of Enasidenib on Day -3","type":"SECONDARY","unitOfMeasure":"percent change"}