Table 3:
Summary of Treatment-Related Adverse Events by System Organ Class and Preferred Term
| System order class preferred term | rhNGF n (%) |
Vehicle n (%) |
Overall n (%) |
|---|---|---|---|
| Number of Subjects | 40 | 20 | 60 |
| Number of treatment related TEATs | 28 (70.0) | 5 (25.0) | 33 (55.0) |
| Eye Disorders | 28 (70.0) | 5 (25.0) | 33 (55.0) |
| Eye pain | 21 (52.5) | 1 (5.0) | 22 (36.7) |
| Eye irritation | 6 (15.0) | 3 (15.0) | 9 (15.0) |
| Photophobia | 7 (17.5) | - | 7 (11.7) |
| Conjunctival Hyperemia | 3 (7.5) | 1 (5.0) | 4 (6.7) |
| Blepharitis | 2 (5.0) | 1 (5.0) | 3 (5.0) |
| Vision Blurred | 3 (7.5) | 1 (5.0) | 4 (6.7) |
| Dry Eye | 2 (5.0) | 1 (5.0) | 3 (5.0) |
| Foreign Body Sensation | 2 (5.0) | 1 (5.0) | 3 (5.0) |
| Lacrimation Increased | 2 (5.0) | 1 (5.0) | 3 (5.0) |
| Uveitis | 2 (5.0) | - | 2 (3.3) |
| Abnormal Sensation In Eye | - | 1 (5.0) | 1 (1.7) |
| Blepharochalasis | 1 (2.5) | - | 1 (1.7) |
| Chalazion | 1 (2.5) | - | 1 (1.7) |
| Dry eye | - | 1 (5.0) | 1 (1.7) |
| Eye Inflammation | 1 (2.5) | - | 1 (1.7) |
| Eye Swelling | 1 (2.5) | - | 1 (1.7) |
| Eyelid Edema | 1 (2.5) | - | 1 (1.7) |
| Eyelid Ptosis | 1 (2.5) | - | 1 (1.7) |
| Keratitis | 1 (2.5) | - | 1 (1.7) |
| Ocular Discomfort | 1 (2.5) | - | 1 (1.7) |
| Ocular Hyperemia | 1 (2.5) | - | 1 (1.7) |
| Punctate Keratitis | - | 1 (5.0) | 1 (1.7) |
| Nervous System Disorders | 3 (7.5) | - | 3 (5.0) |
| Headache | 3 (7.5) | - | 3 (5.0) |
TEATs = Treatment emergent adverse events; rhNGF = recombinant human nerve growth factor