Table 3b Dose-limiting toxicities in cycle 1
Level 1 | Level 2 | Level 3 | Level 4 | Level 5 | Total | |
|---|---|---|---|---|---|---|
Cohort | 1 | 2 | 3 | 4 | 5 | n |
No. of subjects evaluable for DLT | 2/4 | 9/11 | 6/6 | 6/7 | 3/3 | 26/31 |
Subjects with DLT | — | 1 | 1 | 2 | 2 | 6 |
Haematological | ||||||
Neutropenia | — | — | — | 1 | — | 1 |
Febrile neutropenia | — | — | — | 1 | — | 1 |
Thrombocytopenia | — | 1 | 1 | 1 | — | 3 |
Nonhaematological | ||||||
Bilirubinemia | — | — | — | 1 | — | 1 |
Fatigue | — | — | — | — | 1 | 1 |
Ototoxicity | — | — | — | — | 1 | 1 |
Hypokalemia | — | — | — | 1 | — | 1 |
Hyponatremia | — | — | — | 1 | — | 1 |
