Table 3 Overall toxicities at the recommended dose in phases I and II of the study (N=52)
Toxicity | Grades 1–2 ( N, %) | Grades 3–4 ( N, %) |
---|---|---|
Nausea | 33 (63.5) | 5 (9.6) |
Vomiting | 12 (23.1) | 3 (5.7) |
Anorexia | 30 (57.7) | 5 (9.6) |
Oesophagitis | 10 (19.2) | 2 (3.8) |
Diarrhoea | 2 (3.8) | 0 |
Abdominal pain | 2 (3.8) | 0 |
Stomatitis | 13 (25.0) | 1 (1.9) |
Fatigue | 29 (55.8) | 1 (1.9) |
Weight loss | 6 (11.5) | 0 |
HFS | 4 (7.7) | 0 |
Leukopenia | 37 (71.1) | 6 (11.5) |
Neutropenia | 25 (48.1) | 2 (3.8) |
Anaemia | 11 (21.2) | 0 |
Thrombocytopenia | 27 (51.9) | 0 |
ALT/AST | 1 (1.9) | 0 |