Table S3.
Summary of TEAEs in selected age subgroups occurring at an incidence of ≥1% by treatment (safety population)
| AEs (MedDRA PT), n (%) | Olopatadine 0.77% (n=330)
|
Vehicle (n=169)
|
||
|---|---|---|---|---|
| 2–17 years (n=51) | ≥18 years (n=279) | 2–17 years (n=24) | ≥18 years (n=145) | |
| Ocular AEs | ||||
| Vision blurred | 0 | 15 (5.4) | 0 | 7 (4.8) |
| Dry eye | 0 | 8 (2.9) | 0 | 5 (3.4) |
| Abnormal sensation in the eye | 2 (3.9) | 5 (1.8) | 0 | 7 (4.8) |
| Corneal staining* | 1 (2.0) | 7 (2.5) | 0 | 7 (4.8) |
| Conjunctival staining* | 2 (3.9) | 4 (1.4) | 1 (4.2) | 0 |
| Eye pruritus | 1 (2.0) | 1 (0.4) | 0 | 1 (0.7) |
| Eye pain | 0 | 3 (1.1) | 0 | 0 |
| Eye irritation | 0 | 1 (0.4) | 1 (4.2) | 4 (2.8) |
| Ocular hyperemia | 0 | 2 (0.7) | 0 | 0 |
| Foreign body sensation in eyes | 1 (2.0) | 1 (0.4) | 0 | 0 |
| Non-ocular AEs | ||||
| Headache | 0 | 3 (1.1) | 0 | 1 (0.7) |
| Dysgeusia | 0 | 8 (2.9) | 0 | 0 |
| Skin discoloration | 1 (2.0) | 0 | 0 | 0 |
Notes:
*
All of the adverse drug reactions of corneal staining and conjunctival staining were reported by one investigator who conducted fluorescein staining at some post-dose visits. Fluorescein staining was not a protocol required procedure and was not conducted at baseline (screening visits) for any subjects. Olopatadine 0.77%, olopatadine hydrochloride solution 0.77%; vehicle, olopatadine hydrochloride solution 0.77% vehicle.
Abbreviations: AE, adverse event; MedDRA, medical dictionary for the regulatory activities; PT, preferred term; TEAE, treatment emergent adverse event.