Table 2 Adverse events (safety population)
System organ class Preferred term | Biosimilar ranibizumab (N = 126) N (%) e |
|---|---|
Total events | 16 (12.70%) 19 |
Eye disorder | 6 (4.76%) 6 |
Corneal edema | 1 (0.79%) 1 |
Dry eye | 1 (0.79%) 1 |
Eye pruritus | 2 (1.59%) 2 |
Iridocyclitis | 1 (0.79%) 1 |
Ocular hyperaemia | 1 (0.79%) 1 |
General disorders and administration site conditions | 6 (4.76%) 6 |
Death | 1 (0.79%) 1 |
Pyrexia | 5 (3.97%) 5 |
Infections and infestations | 1 (0.79%) 1 |
Nasopharyngitis | 1 (0.79%) 1 |
Investigations | 4 (3.17%) 5 |
Raised blood pressure | 1 (0.79%) 1 |
Increase in intraocular pressure | 3 (2.38%) 4 |
Nervous system disorders | 1 (0.79%) 1 |
Headache | 1 (0.79%) 1 |