Table 2. Selected non-haematologic and haematologic events treatment-related adverse events.
|
Dose level 1 (n=3) |
Dose level 2 (n=5) |
Dose level 3 (n=16) |
||||
|---|---|---|---|---|---|---|
| Adverse event | No. | % | No. | % | No. | % |
|
Nausea | ||||||
| Grade 1 | 1 | 33 | 3 | 60 | 8 | 50 |
| Grade 2 | 0 | 0 | 0 | |||
| Grade 3 | 0 | 0 | 1 | 6 | ||
| Grade 4 | 0 | 0 | 0 | |||
|
Vomiting | ||||||
| Grade 1 | 1 | 33 | 1 | 20 | 6 | 38 |
| Grade 2 | 0 | 0 | 2 | 12 | ||
| Grade 3 | 0 | 0 | 0 | |||
| Grade 4 | 0 | 0 | 0 | |||
|
Fatigue | ||||||
| Grade 1 | 0 | 3 | 60 | 6 | 38 | |
| Grade 2 | 2 | 67 | 1 | 20 | 5 | 31 |
| Grade 3 | 1 | 33 | 1 | 20 | 3 | 19 |
| Grade 4 | 0 | 0 | 0 | |||
|
Diarrhoea | ||||||
| Grade 1 | 1 | 33 | 1 | 20 | 2 | 12 |
| Grade 2 | 1 | 33 | 1 | 20 | 3 | 19 |
| Grade 3 | 0 | 1 | 20 | 0 | ||
| Grade 4 | 0 | 0 | 0 | |||
|
Sensory neuropathy | ||||||
| Grade 1 | 1 | 33 | 1 | 20 | 8 | 50 |
| Grade 2 | 1 | 33 | 1 | 20 | 2 | 12 |
| Grade 3 | 0 | 0 | 0 | |||
| Grade 4 | 0 | 0 | 0 | |||
|
Hand-foot syndrome | ||||||
| Grade 1 | 0 | 0 | 2 | 12 | ||
| Grade 2 | 1 | 33 | 1 | 20 | 3 | 19 |
| Grade 3 | 0 | 0 | 2 | 12 | ||
| Grade 4 | 0 | 0 | 0 | |||
|
Neutropenia | ||||||
| Grade 1 | 0 | 2 | 40 | 4 | 25 | |
| Grade 2 | 0 | 0 | 1 | 6 | ||
| Grade 3 | 2 | 67 | 1 | 20 | 4 | 25 |
| Grade 4 | 1 | 33 | 0 | 5 | 31 | |
|
Anaemia | ||||||
| Grade 1 | 1 | 33 | 2 | 40 | 7 | 44 |
| Grade 2 | 2 | 67 | 2 | 40 | 6 | 38 |
| Grade 3 | 0 | 1 | 20 | 2 | 12 | |
| Grade 4 | 0 | 0 | 0 | |||
|
Thrombocytopenia | ||||||
| Grade 1 | 2 | 67 | 2 | 40 | 6 | 38 |
| Grade 2 | 1 | 33 | 1 | 20 | 4 | 25 |
| Grade 3 | 0 | 0 | 0 | |||
| Grade 4 | 0 | 0 | 0 | |||
|
Febrile neutropenia | ||||||
| Grade 1 | 0 | 0 | 0 | |||
| Grade 2 | 0 | 0 | 0 | |||
| Grade 3 | 0 | 0 | 1 | 6 | ||
| Grade 4 | 0 | 0 | 0 | |||