Table 5.
Summary of adverse events (SAS)
| Adverse events, n (%) | All grades (n = 50) | Grades 3–4 (n = 50) |
|---|---|---|
| All causality | ||
| All AEs | 45 (90.0) | 24 (48.0) |
| SAE | 16 (32.0) | 11 (22.0) |
| AEs leading to discontinuation | 7 (14.0) | 4 (8.0) |
| AEs occurring in ≥ 10% of patients | ||
| Pyrexia | 10 (20.0) | 0 |
| Headache | 9 (18.0) | 0 |
| Lymphocyte count decreased | 9 (18.0) | 5 (10.0) |
| Constipation | 8 (16.0) | 0 |
| Nasopharyngitis | 7 (14.0) | 0 |
| γ-Glutamyl transferase increased | 5 (10.0) | 0 |
| Insomnia | 5 (10.0) | 0 |
| Brain edema | 5 (10.0) | 1 (2.0) |
| TRAEs | ||
| All TRAEs | 24 (48.0) | 7 (14.0) |
| Serious TRAEs | 6 (12.0) | 5 (10.0) |
| TRAEs leading to discontinuation | 4 (8.0) | 2 (4.0) |
| TRAEs occurring in ≥ 2 patients | ||
| γ-Glutamyl transferase increased | 4 (8.0) | 0 |
| Lymphocyte count decreased | 3 (6.0) | 1 (2.0) |
| Brain edema | 2 (4.0) | 1 (2.0) |
| Diarrhea | 2 (4.0) | 0 |
| Pyrexia | 2 (4.0) | 0 |
| Hypopituitarism | 2 (4.0) | 0 |
| Rash maculo-papular | 2 (4.0) | 1 (2.0) |
AE adverse event, SAE serious adverse event, SAS safety analysis set, TRAE treatment-related adverse event