Table 3.
Adverse events of grade ≥2 that occurred in >3% in either studied populations
| Adverse events | NEPA (n=60) | Historical controls (APR) (n=62) | ||||||||
| Grade | Grade | |||||||||
| 0 | 1 | 2 | 3 | 4 | 0 | 1 | 2 | 3 | 4 | |
| Alanine transaminase | 60 | 0 | 0 | 0 | 0 | 60 | 0 | 2 | 0 | 0 |
| Constipation | 32 | 28 | 0 | 0 | 0 | 52 | 8 | 2 | 0 | 0 |
| Cough | 56 | 1 | 3 | 0 | 0 | 53 | 9 | 0 | 0 | 0 |
| Dyspepsia | 55 | 2 | 3 | 0 | 0 | 60 | 1 | 1 | 0 | 0 |
| Febrile neutropaenia | 60 | 0 | 0 | 0 | 0 | 57 | 0 | 0 | 5 | 0 |
| Infections | 58 | 0 | 2 | 0 | 0 | 62 | 0 | 0 | 0 | 0 |
| Mucositis—oral cavity | 21 | 37 | 2 | 0 | 0 | 43 | 15 | 3 | 1 | 0 |
| Neutropaenia | 37 | 2 | 12 | 2 | 7 | 27 | 0 | 14 | 8 | 13 |
| Pain | 57 | 1 | 0 | 2 | 0 | 62 | 0 | 0 | 0 | 0 |
| Rectal haemorrhage | 58 | 0 | 2 | 0 | 0 | 62 | 0 | 0 | 0 | 0 |
| Upper respiratory infection | 52 | 3 | 3 | 2 | 0 | 62 | 0 | 0 | 0 | 0 |