Table 2 Dose-limiting toxicities at cycle 1 and adverse events at subsequent cycles
DLTs at the first cycle (n = 3) | ||
|---|---|---|
Dose level, mg/m 2 | Patients, n | Event |
8.4 | – | – |
10 | 1 | Grade 3 diarrhoea |
12 | 2 | Grade 3 diarrhoea (both patients) |
Adverse events at cycles ≥ 2 (n = 13) | ||
Dose level, mg/m 2 | Patients, n | Event |
8.4 | 4 | Grade 3 asthenia (three patients) |
Grade 3 diarrhoea | ||
10 | 1 | Grade 3 haematuria |
Grade 3 dysuria | ||
12 | 3 | Grade 3 asthenia (two patients) |
Febrile neutropenia | ||
Neutropenia Grade 4 for > 5 days (two patients) | ||
Grade 3 diarrhoea | ||
Grade 3 asthenia | ||