Summary of treatment-emergent adverse events (safety population)
| Nepafenac (N=83) | Vehicle (N=83) | |||
|---|---|---|---|---|
| Adverse event category | N | Per cent | N | Per cent |
| Patients discontinued due to an AE | 4 | 4.8 | 7 | 8.4 |
| Discontinued due to a non-fatal SAE | 1 | 1.2 | 2 | 2.4 |
| Discontinued due to a non-serious AE | 3 | 3.6 | 5 | 6.0 |
| Treatment-related | 2 | 2.4 | 2 | 2.4 |
| Not related to treatment | 1 | 1.2 | 3 | 3.6 |
| Patients with at least one treatment-emergent AE related to treatment (ADR) | 6 | 7.2 | 6 | 7.2 |
| Most frequent ADRs (incidence of 1% or greater) | ||||
| Corneal oedema | 0 | 0.0 | 1 | 1.2 |
| Punctate keratitis | 4 | 4.8 | 3 | 3.6 |
| Corneal disorder | 0 | 0.0 | 1 | 1.2 |
| Corneal erosion | 1 | 1.2 | 0 | 0.0 |
| Keratitis | 0 | 0.0 | 1 | 1.2 |
| Conjunctival hyperaemia | 0 | 0.0 | 1 | 1.2 |
| Eye irritation | 0 | 0.0 | 1 | 1.2 |
| Dermatitis allergic | 1 | 1.2 | 0 | 0.0 |
Nepafenac=nepafenac ophthalmic suspension, 0.1%; Vehicle=nepafenac ophthalmic suspension, vehicle.
ADR, adverse drug reaction; AE, adverse event; SAE, serious adverse event.