Table 4.
Adverse events
| Adverse events | |||
|---|---|---|---|
| Mild | Moderate | Total | |
| Patients included in safety analysis | 166 | 166 | 166 |
| Number of events (number of cases) | 38 (22) | 4 (4) | 42 (26) |
| Type | n | % | n | % | n | % |
|---|---|---|---|---|---|---|
| Eye disorders | 34 | – | 3 | – | 37 | – |
| Eye lid sulcus deepened | 8 | 4.8 | 8 | 4.8 | ||
| Growth of eyelashes | 5 | 3 | 5 | 3 | ||
| Blepharal pigmentation | 3 | 1.8 | 1 | 0.6 | 4 | 2.4 |
| Superficial punctate keratopathy | 4 | 2.4 | 4 | 2.4 | ||
| Dry eyes | 3 | 1.8 | 3 | 1.8 | ||
| Foreign body sensation in eyes | 2 | 1.2 | 2 | 1.2 | ||
| Eyelid ptosis | 1 | 0.6 | 1 | 0.6 | ||
| Eye irritation | 1 | 0.6 | 1 | 0.6 | 2 | 1.2 |
| Eye pruritus | 1 | 0.6 | 1 | 0.6 | 2 | 1.2 |
| Iritis | 1 | 0.6 | 1 | 0.6 | ||
| Keratitis | 1 | 0.6 | 1 | 0.6 | ||
| Vision blurred | 1 | 0.6 | 1 | 0.6 | ||
| Visual acuity reduced | 1 | 0.6 | 1 | 0.6 | ||
| Conjunctival hyperemia | 1 | 0.6 | 1 | 0.6 | ||
| Corneal epitheliopathy | 1 | 0.6 | 1 | 0.6 | ||
| Other | 4 | – | 1 | – | 5 | – |
| Blood pressure increased | 1 | 0.6 | 1 | 0.6 | ||
| Headache | 1 | 0.6 | 1 | 0.6 | ||
| Herpes zoster | 1 | 0.6 | 1 | 0.6 | ||
| Itchy skin | 1 | 0.6 | 1 | 0.6 | ||
| Rash | 1 | 0.6 | 1 | 0.6 |