Table 3. Treatment-related non-haematological adverse eventsa during and after cycle one occurring in ⩾5% of patients for all cohorts combined (N=33).
|
Cycle 1, n (%)
|
After cycle 1, n (%)
|
|||
|---|---|---|---|---|
| Adverse event | All grades | Grade 3 | All grades | Grade 3 |
| Fatigue | 11 (33) | 0 | 10 (30) | 1 (3) |
| Nausea | 10 (30) | 0 | 5 (15) | 1 (3) |
| Diarrhoea | 6 (18) | 0 | 10 (30) | 0 |
| Constipation | 4 (12) | 0 | 3 (9) | 0 |
| Rash | 4 (12) | 0 | 2 (6) | 0 |
| Vomiting | 2 (6) | 0 | 2 (6) | 1 (3) |
| Peripheral oedema | 3 (9) | 0 | 2 (6) | 0 |
| Dyspnea | 3 (9) | 0 | 1 (3) | 0 |
| Anorexia | 1 (3) | 0 | 3 (9) | 0 |
| Pyrexia | 1 (3) | 0 | 2 (6) | 0 |
| Epistaxis | 0 | 0 | 4 (12) | 0 |
| Flatulence | 0 | 0 | 3 (9) | 0 |
| Mucosal inflammation | 0 | 0 | 3 (9) | 0 |
| Chills | 0 | 0 | 2 (6) | 0 |
| Muscular weakness | 0 | 0 | 2 (6) | 0 |
| Cough | 0 | 0 | 2 (6) | 0 |
| Alopecia | 0 | 0 | 2 (6) | 0 |
Adverse events were defined as treatment-related based on having a relationship to study drug reported as ‘yes’ or ‘unknown’. No treatment-related, grade 4/5 adverse events were reported.