Table 3. Treatment-related adverse events (n=19): worst grade reported during treatment period.
|
Gradea |
||||||
|---|---|---|---|---|---|---|
| Toxicity | 1 | 2 | 3 | 4 | Grade 1–4 (%) | Grade 3–4 (%) |
| Haematologic | ||||||
| Leukopenia | 5 | 3 | 0 | 0 | 42.1 | 0 |
| Neutropenia | 4 | 2 | 1 | 0 | 36.8 | 5.3 |
| Anaemia | 3 | 4 | 1 | 0 | 42.1 | 5.3 |
| Thrombocytopenia | 2 | 0 | 0 | 0 | 10.5 | 0 |
| Nonhaematologic | ||||||
| Nausea | 4 | 2 | 1 | 0 | 36.8 | 5.3 |
| Vomiting | 4 | 0 | 0 | 0 | 21.1 | 0 |
| Anorexia | 3 | 0 | 2 | 0 | 26.3 | 10.5 |
| Stomatitis | 3 | 0 | 1 | 0 | 21.1 | 5.3 |
| Diarrhoea | 2 | 2 | 1 | 0 | 26.3 | 5.3 |
| Total bilirubin | 1 | 1 | 0 | 0 | 10.5 | 0 |
| ALT | 2 | 4 | 0 | 0 | 31.6 | 0 |
| AST | 4 | 2 | 0 | 0 | 31.6 | 0 |
| Fatigue | 0 | 0 | 2 | 0 | 10.5 | 10.5 |
| Fever | 0 | 0 | 1 | 0 | 5.3 | 5.3 |
| Rash | 1 | 0 | 0 | 0 | 5.3 | 0 |
| Pigmentation changes | 3 | 0 | 0 | 0 | 15.8 | 0 |
AST=aspartate aminotransferase; ALT=alanine aminotransferase.
NCI Common Toxicity Criteria, version 2.0.