Table 3.
Toxicity Profile
| Dose Level | Toxicity | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|---|
| 200 mg | Oral mucositis | 1 | 1 | 0 | 0 |
| Fatigue | 1 | 2 | 0 | 0 | |
| Rash | 0 | 1 | 0 | 0 | |
| Neutropenia | 0 | 1 | 2 | 3* | |
| Vomit | 1 | 0 | 0 | 0 | |
| 400 mg | Vomit | 1 | 0 | 0 | 0 |
| Neutropenia | 1 | 0 | 2 | 1 | |
| Peripheral edema | 0 | 1 | 0 | 0 | |
| Myalgia | 3 | 0 | 0 | 0 | |
| Skin rash | 1 | 0 | 0 | 0 | |
| 600 mg | Pruritis | 1 | 0 | 0 | 0 |
| Neutropenia | 0 | 0 | 4 | 2 | |
| General weakness | 1 | 0 | 0 | 0 | |
| Peripheral edema | 0 | 1 | 0 | 0 | |
| 800 mg | Pyrexia | 1 | 1 | 0 | 0 |
| Rash | 1 | 0 | 0 | 0 | |
| Generalized edema | 0 | 0 | 1 | 0 | |
| Anorexia | 1 | 0 | 0 | 0 | |
| Headache | 2 | 0 | 0 | 0 | |
| Diarrhea | 1 | 0 | 0 | 0 | |
| Nausea/vomit | 3 | 0 | 0 | 0 | |
| Neutropenia | 0 | 0 | 1 | 4* |
*
G4 neutropenia not lasting >5 days.