TABLE 3.
Treatment‐related adverse events (TRAEs)
| Events | Number of patients [cases (%)] | |||
|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Nausea | 12 (52.2) | 4 (17.4) | 3 (13.0) | 0 (0.0) |
| Anorexia | 11 (47.8) | 3 (13.0) | 3 (13.0) | 0 (0.0) |
| Fatigue | 9 (39.1) | 5 (21.7) | 0 (0.0) | 0 (0.0) |
| Vomiting | 7 (30.4) | 5 (21.7) | 1 (4.3) | 0 (0.0) |
| Diarrhea | 7 (30.4) | 7 (30.4) | 1 (4.3) | 0 (0.0) |
| Weight loss | 4 (17.4) | 2 (8.7) | 1 (4.3) | 0 (0.0) |
| Fever | 2 (8.7) | 2 (8.7) | 0 (0.0) | 0 (0.0) |
| Abdominal pain | 4 (17.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Leukopenia | 4 (17.4) | 6 (26.1) | 2(8.7) | 0 (0.0) |
| Neutropenia | 3 (13.0) | 3 (13.0) | 3 (13.0) | 1 (4.3) |
| Anemia | 1 (4.3) | 2 (8.7) | 1 (4.3) | 0 (0.0) |
| Thrombocytopenia | 4 (17.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| ALT level increase | 3 (13.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| AST level increase | 3 (13.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Blood bilirubin level increase | 1 (4.3) | 0 (0.0) | 1 (4.3) | 0 (0.0) |
| Hyperthyroidism | 4 (17.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hyponatremia | 1 (4.3) | 0 (0.0) | 1 (4.3) | 0 (0.0) |
Note: TRAEs observed in ≥10% of the patients and all the TRAEs of grade 3 or higher are listed; there were no grade 5 TRAEs.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.