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.