Planned dose level, mg/m2 | All | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(N = 31) | ||||||||||||||
1.5 | 3 | 6 | 8.4 | 10 | 12 | |||||||||
(n = 1) | (n = 1) | (n = 4) | (n = 12) | (n = 7) | (n = 6) | |||||||||
Adverse event, n | G3 | G4 | G3 | G4 | G3 | G4 | G3 | G4 | G3 | G4 | G3 | G4 | G3 | G4 |
Non-haematological | ||||||||||||||
Fatigue | – | – | – | – | – | – | 3 | – | – | – | 2 | – | 5 | – |
Diarrhoea | – | – | – | – | – | – | 1 | – | 1 | – | 3 | – | 5 | – |
Haematuria | – | – | – | – | – | – | – | – | 1 | – | – | – | 1 | – |
Febrile neutropenia | – | – | – | – | – | – | – | – | – | – | 1 | – | 1 | – |
Dysuria | – | – | – | – | – | – | – | – | 1 | – | – | – | 1 | – |
Haematological | ||||||||||||||
Neutropenia | – | – | – | – | – | – | 1 | – | – | – | – | 2 | 1 | 2 |
Anaemia | – | – | – | – | – | – | – | 1 | – | – | – | – | – | 1 |
Days to neutrophil nadir, median (range) | – | – | – | 17 | – | – | 22 | |||||||
– | 32–32 | 31–31 | 17–22 | 18–18 | 21–22 | 17–32 | ||||||||
Median neutrophil nadir, x 10 9 /l (range) | – | – | 2.3 | 2.2 | 2.2 | 3.1 | 2.3 | |||||||
(3.4–3.4) | (1.8–1.8) | (1.4–9.0) | (0.9–5.0) | (1.2–5.7) | (0.2–7.3) | (0.2–9.0) |