Table 2.
Grade 3 and 4 adverse events reported in at least 5% of patients
| Placebo (n=313) n (%) | Depatux-m (n=323) n (%) | |||
|---|---|---|---|---|
| Adverse event | Grade 3 | Grade 4 | Grade 3 | Grade 4 |
| Any | 135 (43.1) | 47 (15.0) | 191(59.1) | 69(21.4) |
| Corneal epitheliopathy (CE)a | 2 (0.6) | 0 | 179 (55.4) | 16 (5.0) |
| Thrombocytopenia | 20 (6.4) | 18 (5.8) | 44(13.6) | 46 (14.2) |
| Gamma-glutamyltransferase increased | 2 (0.6) | 1 (0.3) | 33(10.2) | 2 (0.6) |
| Lymphopenia | 37 (11.8) | 4 (1.3) | 23 (7.1) | 4 (1.2) |
| Seizure | 16 (5.4) | 4 (1.3) | 16 (5.0) | 2 (0.6) |
| Alanine aminotransferase increased | 5 (1.6) | 0 | 17 (5.3) | 0 |
| Neutropenia | 15 (4.8) | 10 (3.2) | 9 (2.8) | 6 (1.9) |
aIncludes keratopathy, vision blurred, photophobia, dry eye, eye pain, keratitis, and punctate keratitis.