Table 2.
Grade 3 or above adverse events (AEs) potentially associated with the protocol treatment (attribution: possible, probable, or definite) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0a
| Type of AE | Grade 3 | Grade 4 or 5 |
|---|---|---|
| Dose level 1200 mg/m2, (N = 13) | ||
| Abdominal pain | 1 (7.7%) | 0 |
| Alanine aminotransferase increased | 1 (7.7%) | 0 |
| Alkaline phosphatase increased | 1 (7.7%) | 0 |
| Anemia | 1 (7.7%) | 0 |
| Dyspnea | 1 (7.7%) | 0 |
| GGT increased | 1 (7.7%) | 0 |
| Intracranial hemorrhage | 1 (7.7%) | 0 |
| Platelet count decreased | 1 (7.7%) | 0 |
| Dose level 520 mg/m2, (N = 7) | ||
| Anemia | 1 (14.3%) | 0 |
| Lung infection | 1 (14.3%) | 0 |
a
Data are reported as number of patients (percentage of the treated patients) separately by dose level. GGT = gamma-glutamyl transferase.