TriangleNCT01915498 · OUTCOME
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 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).
What was measured
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).
Analysis population: The safety analysis set includes all participants who received at least 1 dose of study treatment.
Groups in this outcome
Phase 1 Dose Escalation: Enasidenib 30 mg BID
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.
Phase 1 Dose Escalation: Enasidenib 50 mg BID
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.
Phase 1 Dose Escalation: Enasidenib 75 mg BID
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.
Phase 1 Dose Escalation: Enasidenib 100 mg BID
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.
Phase 1 Dose Escalation: Enasidenib 150 mg BID
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.
Phase 1 Dose Escalation: Enasidenib 50 mg QD
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.
Phase 1 Dose Escalation: Enasidenib 75 mg QD
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.
Phase 1 Dose Escalation: Enasidenib 100 mg QD
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.
Phase 1 Dose Escalation: Enasidenib 150 mg QD
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.
Phase 1 Dose Escalation: Enasidenib 200 mg QD
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.
Phase 1 Dose Escalation: Enasidenib 300 mg QD
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.
Phase 1 Dose Escalation: Enasidenib 450 mg QD
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.
Phase 1 Dose Escalation: Enasidenib 650 mg QD
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.
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 7 |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 7 |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 7 |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 8 |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 5 |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 9 |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 7 |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 22 |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 6 |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 14 |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 9 |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 7 |
Reported measurements
Any treatment-emergent adverse event (TEAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 8 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 22 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 14 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
TEAE Related to Investigational Product (IP)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 17 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 14 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
Grade 3-4 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 8 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 21 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 14 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 8 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
Grade 3-4 TEAE Related to IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
Grade 5 TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 5 TEAE Related to IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
Serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 19 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
Serious TEAE Related to IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
TEAE Leading to Discontinuation (D/C) of IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
TEAE Related to IP Leading to D/C of IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
TEAE Leading to Reduction of IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
TEAE Related to IP Leading to Reduction of IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
TEAE Leading to Interruption of IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
TEAE Related to IP Leading to Interruption of IP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation: Enasidenib 30 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 50 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 22
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 14
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 5
- title
- Any treatment-emergent adverse event (TEAE)
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 14
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 4
- title
- TEAE Related to Investigational Product (IP)
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 21
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 14
- group Id
- OG010
- value
- 8
- group Id
- OG011
- value
- 5
- title
- Grade 3-4 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 9
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 4
- title
- Grade 3-4 TEAE Related to IP
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 2
- title
- Grade 5 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Grade 5 TEAE Related to IP
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 19
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 5
- title
- Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 2
- title
- Serious TEAE Related to IP
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 2
- title
- TEAE Leading to Discontinuation (D/C) of IP
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- TEAE Related to IP Leading to D/C of IP
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 3
- title
- TEAE Leading to Reduction of IP
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 3
- title
- TEAE Related to IP Leading to Reduction of IP
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 22
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 14
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 5
- 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
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set includes all participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- 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
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice