Table 4.
Treatment‐emergent adverse events
| Cohort 1 (n = 13) | Cohort 2 (n = 18) | Cohort 3 (n = 18) | Cohort 4 (n = 43) | Overall (N = 92) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
| Haematological adverse events – n (%) | ||||||||||
| Anaemia | 31 | 23 | 33 | 28 | 33 | 17 | 23 | 9 | 28 | 16 |
| Thrombocytopenia | 38 | 0 | 28 | 22 | 22 | 11 | 21 | 9 | 25 | 11 |
| Neutropenia | 8 | 0 | 0 | 0 | 17 | 6 | 2 | 2 | 5 | 2 |
| Nonhaematological adverse events (>15%) – n (%) | ||||||||||
| Diarrhoea | 38 | 0 | 44 | 0 | 56 | 6 | 63 | 2 | 53 | 2 |
| Fatigue | 23 | 0 | 39 | 0 | 50 | 11 | 49 | 0 | 43 | 2 |
| Nausea | 46 | 0 | 28 | 0 | 39 | 0 | 23 | 0 | 30 | 0 |
| Muscle Spasms | 31 | 0 | 33 | 0 | 17 | 0 | 21 | 0 | 24 | 0 |
| Cough | 31 | 0 | 17 | 0 | 11 | 0 | 28 | 0 | 23 | 0 |
| Insomnia | 8 | 0 | 28 | 0 | 6 | 0 | 28 | 0 | 21 | 0 |
| Upper respiratory tract infection | 23 | 0 | 11 | 0 | 39 | 0 | 16 | 0 | 21 | 0 |
| Arthralgia | 23 | 0 | 22 | 0 | 22 | 0 | 16 | 0 | 20 | 0 |
| Dizziness | 15 | 0 | 22 | 0 | 11 | 0 | 21 | 0 | 18 | 0 |
| Back pain | 8 | 0 | 28 | 0 | 17 | 0 | 16 | 2 | 17 | 1 |
| Pain in the extremity | 8 | 0 | 28 | 6 | 0 | 0 | 23 | 2 | 17 | 2 |
| Pyrexia | 31 | 0 | 6 | 0 | 22 | 0 | 14 | 0 | 16 | 0 |
| Dyspnea | 15 | 0 | 22 | 0 | 11 | 6 | 14 | 2 | 15 | 2 |