{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"105"}]}],"title":"Any Treatment-emergent Adverse Event (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"88"}]}],"title":"TEAE Related to Investigational Product (IP)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"92"}]}],"title":"Grade 3-4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"48"}]}],"title":"Grade 3-4 TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}],"title":"Grade 5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 5 TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"85"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"}]}],"title":"Serious TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"}]}],"title":"TEAE Leading to Discontinuation (D/C) of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"TEAE Related to IP Leading to D/C of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"TEAE Leading to Reduction of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"TEAE Related to IP Leading to Reduction of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"49"}]}],"title":"TEAE Leading to Interruption of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"}]}],"title":"TEAE Related to IP Leading to Interruption of IP"}],"denoms":[{"counts":[{"groupId":"OG000","value":"105"}],"units":"Participants"}],"description":"A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: - Resulted in death; - Was life threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).","groups":[{"description":"Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG000","title":"Phase 2: Enasidenib 100 mg QD"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment","reportingStatus":"POSTED","timeFrame":"From the first dose of investigational product (IP) up to 28 days after the last dose, up to the data cutoff of date of 01 September 2017; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).","title":"Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}