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Investigational Product (IP)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"21"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"14"},{"groupId":"OG010","value":"8"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"7"}]}],"title":"Grade 3-4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"10"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"9"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"4"}]}],"title":"Grade 3-4 TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"2"},{"groupId":"OG012","value":"0"}]}],"title":"Grade 5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"}]}],"title":"Grade 5 TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"5"},{"groupId":"OG007","value":"19"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"11"},{"groupId":"OG010","value":"7"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"6"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"9"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"5"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"2"},{"groupId":"OG012","value":"2"}]}],"title":"Serious TEAE Related to IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"2"},{"groupId":"OG012","value":"2"}]}],"title":"TEAE Leading to Discontinuation (D/C) of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"1"}]}],"title":"TEAE Related to IP Leading to D/C of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"6"}]}],"title":"TEAE Leading to Reduction of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"6"}]}],"title":"TEAE Related to IP Leading to Reduction of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"10"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"9"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"6"}]}],"title":"TEAE Leading to Interruption of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"7"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"2"},{"groupId":"OG012","value":"6"}]}],"title":"TEAE Related to IP Leading to Interruption of IP"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"22"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"14"},{"groupId":"OG010","value":"9"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"7"}],"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; • Requires 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 30 mg tablets twice a day (BID) 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 Escalation: Enasidenib 30 mg BID"},{"description":"Participants received enasidenib 50 mg tablets BID 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 Escalation: Enasidenib 50 mg BID"},{"description":"Participants received enasidenib 75 mg tablets BID 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 Escalation: Enasidenib 75 mg BID"},{"description":"Participants received enasidenib 100 mg tablets BID 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 Escalation: Enasidenib 100 mg BID"},{"description":"Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG004","title":"Phase 1 Dose Escalation: Enasidenib 150 mg BID"},{"description":"Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG005","title":"Phase 1 Dose Escalation: Enasidenib 50 mg QD"},{"description":"Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG006","title":"Phase 1 Dose Escalation: Enasidenib 75 mg QD"},{"description":"Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG007","title":"Phase 1 Dose Escalation: Enasidenib 100 mg QD"},{"description":"Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG008","title":"Phase 1 Dose Escalation: Enasidenib 150 mg QD"},{"description":"Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG009","title":"Phase 1 Dose Escalation: Enasidenib 200 mg QD"},{"description":"Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG010","title":"Phase 1 Dose Escalation: Enasidenib 300 mg QD"},{"description":"Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG011","title":"Phase 1 Dose Escalation: Enasidenib 450 mg QD"},{"description":"Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG012","title":"Phase 1 Dose Escalation: Enasidenib 650 mg QD"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety analysis set includes all participants 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 date of 01 September 2017; median treatment duration in the dose escalation phase was 5.0 months (range 0.4 to 34.2 months).","title":"Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}