AEs
| AEs . | Safety population (N = 207)∗ . | |
|---|---|---|
| All grades† . | Grade ≥3‡ . | |
| n (%) . | ||
| All treatment-related AEs | 177 (85.5) | 137 (66.2) |
| Blood and lymphatic system disorders | 112 (58.9) | 103 (49.8) |
| Neutropenia | 76 (36.7) | 52 (25.1) |
| Febrile neutropenia | 59 (28.5)§ | 53 (25.6) |
| Thrombocytopenia | 23 (11.1) | 15 (7.3) |
| Anemia | 15 (7.2) | 10 (4.8) |
| Pancytopenia | 11 (5.3) | 8 (3.8) |
| Nonhematologic AEs | ||
| Pyrexia | 46 (22.2) | 9 (4.4) |
| Diarrhea | 30 (14.5) | 2 (1.0) |
| Constipation | 29 (14.0) | 1 (0.5) |
| Asthenia | 26 (12.6) | 2 (1.0) |
| Nausea | 23 (11.1) | 0 (0.0) |
| Fatigue | 21 (10.1) | 2 (1.0) |
| Oedema peripheral | 14 (6.8) | 0 (0.0) |
| Hypokalemia | 14 (6.8) | 4 (1.9) |
| Vomiting | 13 (6.3) | 0 (0.0) |
| Infections | ||
| Pneumonia | 21 (10.1) | 15 (7.2) |
| Sepsis | 12 (5.8) | 12 (5.8) |
| COVID-19 | 11 (5.3) | 2 (1.0) |
| AEs . | Safety population (N = 207)∗ . | |
|---|---|---|
| All grades† . | Grade ≥3‡ . | |
| n (%) . | ||
| All treatment-related AEs | 177 (85.5) | 137 (66.2) |
| Blood and lymphatic system disorders | 112 (58.9) | 103 (49.8) |
| Neutropenia | 76 (36.7) | 52 (25.1) |
| Febrile neutropenia | 59 (28.5)§ | 53 (25.6) |
| Thrombocytopenia | 23 (11.1) | 15 (7.3) |
| Anemia | 15 (7.2) | 10 (4.8) |
| Pancytopenia | 11 (5.3) | 8 (3.8) |
| Nonhematologic AEs | ||
| Pyrexia | 46 (22.2) | 9 (4.4) |
| Diarrhea | 30 (14.5) | 2 (1.0) |
| Constipation | 29 (14.0) | 1 (0.5) |
| Asthenia | 26 (12.6) | 2 (1.0) |
| Nausea | 23 (11.1) | 0 (0.0) |
| Fatigue | 21 (10.1) | 2 (1.0) |
| Oedema peripheral | 14 (6.8) | 0 (0.0) |
| Hypokalemia | 14 (6.8) | 4 (1.9) |
| Vomiting | 13 (6.3) | 0 (0.0) |
| Infections | ||
| Pneumonia | 21 (10.1) | 15 (7.2) |
| Sepsis | 12 (5.8) | 12 (5.8) |
| COVID-19 | 11 (5.3) | 2 (1.0) |
FLT3-ITD, FMS-like tyrosine kinase-3 internal tandem duplication; IDH1/2, isocitrate dehydrogenase 1 and 2; NPM1, Nucleophosmin 1.
The safety population included all patients who received at least 1 dose of Ven.
AEs at any grade reported in at least 5% of patients are listed.
AEs of grade ≥3 that were reported in at least 5% of patients are listed.
Six patients were defined as grade 2 febrile neutropenia by the investigators.