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 |