Table 2. Toxicity events deemed possibly related (grade 2 or higher).
|
Dose level 1 (N=6 patients) | ||||
|---|---|---|---|---|
| Event | Grade 2—N | Grade 2—% | Grade 3—N | Grade 3—% |
| ALT increased | 1 | 16.7 | 0 | 0 |
| Alopecia | 5 | 83.3 | 0 | 0 |
| Diarrhoea | 1 | 16.7 | 0 | 0 |
| Fatigue | 1 | 16.7 | 0 | 0 |
| GGT increased | 1 | 16.7 | 0 | 0 |
| Headache | 1 | 16.7 | 0 | 0 |
| Hypertension | 3 | 50 | 0 | 0 |
| Lymphopenia | 0 | 0 | 1 | 16.7 |
| Neutropenia | 0 | 0 | 1 | 16.7 |
| Peripheral sensory neuropathy | 1 | 16.7 | 0 | 0 |
|
Dose level 2 (N=3 patients) |
||||||
|---|---|---|---|---|---|---|
| Event | Grade 2—N | Grade 2—% | Grade 3—N | Grade 3—% | Grade 4—N | Grade 4—% |
| ALT increased | 0 | 0 | 1 | 33.3 | 1 | 33.3 |
| Alopecia | 1 | 33.3 | 0 | 0 | 0 | 0 |
| AST increased | 0 | 0 | 1 | 33.3 | 0 | 0 |
| Bilirubin elevation | 1 | 33.3 | 0 | 0 | 0 | 0 |
| Diarrhoea | 1 | 33.3 | 0 | 0 | 0 | 0 |
| Fatigue | 1 | 33.3 | 0 | 0 | 0 | 0 |
| GGT increased | 1 | 33.3 | 2 | 66.7 | 0 | 0 |
| Hypertension | 1 | 33.3 | 1 | 33.3 | 0 | 0 |
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transpeptidase.