{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"25"},{"groupId":"OG003","value":"27"}]}],"title":"Any Treatment-emergent Adverse Event (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"23"}]}],"title":"TEAE Related to Investigational Product (IP)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"20"}]}],"title":"Grade 3-4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"7"}]}],"title":"Grade 3-4 TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"6"}]}],"title":"Grade 5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"Grade 5 TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"17"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"2"}]}],"title":"Serious TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"4"}]}],"title":"TEAE Leading to Discontinuation (D/C) of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"}]}],"title":"TEAE Related to IP Leading to D/C of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"TEAE Leading to Reduction of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"TEAE Related to IP Leading to Reduction of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"16"},{"groupId":"OG003","value":"9"}]}],"title":"TEAE Leading to IP Interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"3"}]}],"title":"TEAE Related to IP Leading to Interruption of IP"}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"25"},{"groupId":"OG003","value":"27"}],"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 ≥ 60 years old with relapsed or refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib 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 1 Dose Expansion Arm 1: Enasidenib 100 mg QD"},{"description":"Participants \\< 60 years old with relapsed, refractory AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG001","title":"Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD"},{"description":"Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG002","title":"Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD"},{"description":"Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG003","title":"Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants in Phase 1 Expansion 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 of IP up to the data cutoff date of 01 September 2017; median treatment duration in Part 1 Expansion was 5.2 months (range 0.5 to 32.8 months).","title":"Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}