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 |
Adverse event considered to be related to the study medication.
Paralysis secondary to brain metastasis.