Table 5 Nonhaematologic toxicities
Phase I | |||||||
---|---|---|---|---|---|---|---|
Dose level | 60N | 60P | 65P | 70P | 75P | 80P | Phase II |
Number of patients (cycles) | 7 (13) | 5 (8) | 5 (14) | 4 (9) | 6 (15) | 2 (2) | 48 (140) |
Fatigue | |||||||
Grade 2 | 0 | 1 (1) | 1 (1) | 0 | 0 | 0 | 12 (16) |
Grade 3 | 0 | 0 | 0 | 0 | 0 | 2 (2) | 2 (2) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Nausea | |||||||
Grade 2 | 5 (8) | 3 (3) | 3 (6) | 3 (5) | 5 (10) | 0 | 24 (40) |
Grade 3 | 0 | 1 (1) | 0 | 1 (1) | 0 | 2 (2) | 7 (10) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Infection | |||||||
Grade 2 | 1 (1) | 0 | 1 (2) | 2 (2) | 1 (1) | 0 | 9 (14) |
Grade 3 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 1 (1) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
+NPGa ⩾3 | 1 (1) | 0 | 0 | 0 | 1 (1) | 2 (2) | 11 (13) |
Early diarrhoea | |||||||
Grade 2 | 1 (1) | 1 (2) | 1 (1) | 1 (1) | 3 (4) | 0 | 17 (23) |
Grade 3 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 1 (1) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Late diarrhoea | |||||||
Grade 2 | 2 (2) | 2 (2) | 2 (3) | 1 (1) | 2 (3) | 0 | 7 (9) |
Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (3) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 2 (2) | 0 |
Total bilirubin | |||||||
Grade 2 | 1 (1) | 0 | 1 (2) | 1 (3) | 1 (1) | 2 (2) | 7 (13) |
Grade 3 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 4 (4) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Transaminases | |||||||
Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (5) |
Grade 3 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 3 (6) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Hyponatremia | |||||||
Grade 2 | 2 (3) | 0 | 0 | 0 | 2 (2) | 0 | 11 (17) |
Grade 3 | 1 (1) | 0 | 0 | 1 (1) | 0 | 1 (1) | 1 (1) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |