Table 2. Toxicity by dose levels.
|
NCI-CTC grade
|
|||||||||
|---|---|---|---|---|---|---|---|---|---|
| Dose levels 1–4 | Dose level 5 | Dose level 6 | |||||||
|
(n=12)
|
(n=6)
|
(n=2)
|
|||||||
| Toxicity | Grade 1/2 | Grade 3 | Grade 4 | Grade 1/2 | Grade 3 | Grade 4 | Grade 1/2 | Grade 3 | Grade 4 |
| Haematologic | |||||||||
| Neutropenia | 2 | 1 | 2 | 1 | 2 | ||||
| Febrile neutropenia | 1 | ||||||||
| Thrombocytopenia | 1 | 1 | 1 | ||||||
| Gastrointestinal | |||||||||
| Nausea/vomiting | 7 | 2 | |||||||
| Colitis | 2 | 1 | |||||||
| Diarrhoea | 1 | 3 | 1 | 1 | |||||
| Stomatitis | 1 | 1 | |||||||
| Proctitis | 1 | 1 | |||||||
| Genitourinary | |||||||||
| Cystitis | 1 | ||||||||
| Skin, local toxicity | 1 | ||||||||
| Fatigue/asthenia | 1 | ||||||||
| Fever | 1 | ||||||||
NCI-CTC=National Cancer Institute Common Toxicity Criteria.
Note: Most severe toxicity of each type experienced by each patient.