{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Any treatment-emergent adverse event (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"TEAE Related to Investigational Product (IP)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}],"title":"Grade 3-4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Grade 3-4 TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Grade 5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Grade 5 TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Serious TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"TEAE Leading to Discontinuation (D/C) of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"TEAE Related to IP Leading to D/C of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"TEAE Leading to Reduction of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"TEAE Related to IP Leading to Reduction of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"TEAE Leading to Interruption of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"TEAE Related to IP Leading to Interruption of IP"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"}],"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 remaining on treatment as of the 01 September 2017 data cut-off date continued to receive enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG000","title":"Safety Follow-up: Enasidenib"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants who received at least 1 dose of study treatment during the Safety Follow-up Period.","reportingStatus":"POSTED","timeFrame":"From the primary analysis cut-off date of 01 September 2017 to the final analysis cut-off date of 29 July 2019, a maximum of 23 months.","title":"Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}