Table 2. Summary of adverse events (safety population).
| AE category, n (%) | Difluprednate 0.05% (n=39) | Prednisolone acetate 1% (n=40) |
|---|---|---|
| Death | 0 (0.0) | 0 (0.0) |
| Serious AE | 8 (20.5) | 11 (27.5) |
| Discontinuation due to AE | 0 (0.0) | 0 (0.0) |
| ⩾1 AE (related or not related to study medication) | 29 (74.4) | 30 (75.0) |
| Conjunctivitis | 3 (7.7) | 0 (0.0) |
| Posterior capsule opacification | 3 (7.7) | 0 (0.0) |
| Eye inflammation | 0 (0.0) | 2 (5.0) |
| Pyrexia | 0 (0.0) | 2 (5.0) |
| Nasopharyngitis | 5 (12.8) | 2 (5.0) |
| Ear infection | 3 (7.7) | 1 (2.5) |
| Sinusitis | 2 (5.1) | 0 (0.0) |
| Medical observation | 6 (15.4) | 10 (25.0) |
| Intraocular pressure increased | 3 (7.7) | 1 (2.5) |
| Hypotonia | 0 (0.0) | 2 (5.0) |
| Rash | 1 (2.6) | 2 (5.0) |
| Dermatitis diaper | 0 (0.0) | 2 (5.0) |
| Cataract operation (non-study eye) | 3 (7.7) | 6 (15.0) |
| ⩾1 AE related to treatment (adverse drug reaction) | 3 (7.7) | 2 (5.0) |
| Corneal oedema | 1 (2.6) | 0 (0.0) |
| Ocular hypertension | 0 (0.0) | 1 (2.5) |
| Intraocular pressure increased | 2 (5.1) | 1 (2.5) |
Abbreviation: AE, adverse event.