Treatment-related TEAEs of grades 3 or 4 occurring in ≥2% of all patients
| TEAE . | Enasidenib 100 mg per day (n = 153) . | All patients (N = 239) . | ||
|---|---|---|---|---|
| No. . | % . | No. . | % . | |
| Hyperbilirubinemia* | 13 | 8 | 29 | 12 |
| IDH differentiation syndrome† | 11 | 7 | 15 | 6 |
| Anemia | 10 | 7 | 12 | 5 |
| Thrombocytopenia‡ | 8 | 5 | 15 | 6 |
| Tumor lysis syndrome | 5 | 3 | 8 | 3 |
| Decreased appetite | 3 | 2 | 6 | 3 |
| Leukocytosis | 2 | 1 | 6 | 3 |
| Fatigue | 2 | 1 | 6 | 3 |
| Nausea | 2 | 1 | 5 | 2 |
| Lipase increased | 2 | 1 | 5 | 2 |
| TEAE . | Enasidenib 100 mg per day (n = 153) . | All patients (N = 239) . | ||
|---|---|---|---|---|
| No. . | % . | No. . | % . | |
| Hyperbilirubinemia* | 13 | 8 | 29 | 12 |
| IDH differentiation syndrome† | 11 | 7 | 15 | 6 |
| Anemia | 10 | 7 | 12 | 5 |
| Thrombocytopenia‡ | 8 | 5 | 15 | 6 |
| Tumor lysis syndrome | 5 | 3 | 8 | 3 |
| Decreased appetite | 3 | 2 | 6 | 3 |
| Leukocytosis | 2 | 1 | 6 | 3 |
| Fatigue | 2 | 1 | 6 | 3 |
| Nausea | 2 | 1 | 5 | 2 |
| Lipase increased | 2 | 1 | 5 | 2 |
A treatment-related TEAE was defined as any event that began or worsened on or after the start of enasidenib use until 28 days after the last dose and was considered by the treating physician to be possibly or probably related to enasidenib. TEAEs were coded by using the Medical Dictionary for Regulatory Activities, version 16.0.
Includes the preferred terms “hyperbilirubinemia” and “blood bilirubin increased.”
Preferred term is “retinoic acid syndrome.”
Includes the preferred terms “thrombocytopenia” and “platelet count decreased.”