TABLE 2.
Summary of AEs
| AE | Safety Populationa (N = 94) |
|---|---|
| Any AE, No. of patients (%) | 93 (98.9) |
| AEs that occurred in ≥20% of patients (grouped term), No. of patients (%) | |
| Nausea | 42 (44.7) |
| Febrile neutropenia | 36 (38.3) |
| Diarrhea | 33 (35.1) |
| Edema | 30 (31.9) |
| Vomiting | 29 (30.9) |
| Neutropenia | 28 (29.8) |
| Transaminitis | 27 (28.7) |
| Differentiation syndrome | 26 (27.7) |
| Hypokalemia | 26 (27.7) |
| Epistaxis | 25 (26.6) |
| QTc prolongation | 24 (25.5) |
| Thrombocytopenia | 22 (23.4) |
| Abdominal pain | 22 (23.4) |
| Rash | 22 (23.4) |
| Anemia | 21 (22.3) |
| Constipation | 21 (22.3) |
| Decreased appetite | 21 (22.3) |
| Fatigue | 20 (21.3) |
| Any grade ≥3 AE, No. of patients (%) | 86 (91.5) |
| AEs grade ≥3 (grouped term) that occurred in ≥10% of patients, No. of patients (%) | |
| Febrile neutropenia | 35 (37.2) |
| Neutropenia | 27 (28.7) |
| Thrombocytopenia | 20 (21.3) |
| Anemia | 17 (18.1) |
| Differentiation syndrome | 15 (16.0) |
| QTc prolongation | 13 (13.8) |
| Sepsis | 11 (11.7) |
| Hypokalemia | 10 (10.6) |
| AEs leading to dose modification, No. (%) | |
| Dose reduction | 9 (9.6) |
| Dose interruption | 41 (43.6) |
| Drug discontinuation | 12 (12.8) |
| Death | 14 (14.9) |
NOTE. Data cutoff: July 24, 2023.
Abbreviations: AE, adverse event; KMT2A, lysine methyltransferase 2A.
a
Defined as patients with KMT2A-rearranged acute leukemia having received at least one dose of revumenib.