Table 3. Summary of grade 3 and 4 toxicities.
|
Dose level
|
|||||
|---|---|---|---|---|---|
| Cohort 1 (N=6) | Cohort 2 (N=2) | Cohort 2A (N=6) | Cohort 3A (N=5) | All cohorts (N=19) | |
| All body systems | |||||
| Number of patients with at least one grade 3 or 4 toxicity | 3 | 2 | 2 | 4 | 11 (58%) |
| Gastrointestinal disorders | |||||
| Diarrhoea | 2a | 2a | 4 | ||
| Nausea | 1 | 1 | |||
| Abdominal Pain | 1 | 1 | |||
| Vomiting | 1 | 1 | |||
| Stomatitis | 1a | 1 | |||
| General disorders | |||||
| Fatigue | 1a | 1 | 1a | 1a | 4 |
| Nervous system disorders | |||||
| Neuropathy | 1b | 1 | |||
| Infections | |||||
| Lower respiratory tract infection | 1 | 1 | |||
| Febrile neutropaenia | 1a | 1a | 2 | ||
| Candidiasis | 1 | 1 | |||
| Cystitis | 1 | 1 | |||
| Urinary tract infection | 1 | 1 | |||
| Psychiatric disorders | |||||
| Depression | 1 | 1 | |||
a
Adverse event considered to be related to the study medication.
b
Paralysis secondary to brain metastasis.