Table 4 Top 10 most common known ocular AEs of netarsudil in phase 3 clinical trials and in our study
AEs reported in phase 3 clinical trials [10] | AE signals detected in our study | |||
|---|---|---|---|---|
AEs | N (% of patients) †| AEs | N (% of AE reports) ‡ | ROR (95% CI) |
Conjunctival hyperemia | 456 (54.4%) | Conjunctival hyperemia | 256 (19.8%) | 2004.86 (1723.4, 2332.29) |
Corneal verticillata | 175 (20.9%) | Vision blurred | 131 (10.1%) | 21.71 (18.11, 26.01) |
Instillation site pain | 167 (19.9%) | Eye irritation | 93 (7.2%) | 31.78 (25.72, 39.26) |
Conjunctival hemorrhage | 144 (17.2%) | Ocular hyperemia | 89 (6.9%) | 36.18 (29.16, 44.9) |
Instillation site erythema | 76 (9.1%) | Corneal edema | 82 (6.3%) | 696.31 (550.39, 880.92) |
Corneal staining | 79 (9.4%) | Visual acuity reduced | 82 (6.3%) | 121.09 (96.62, 151.74) |
Blurred vision | 62 (7.4%) | Lacrimation increased | 72 (5.6%) | 44.89 (35.37, 56.98) |
Increased lacrimation | 60 (7.2%) | Corneal verticillata | 66 (5.1%) | 5737.44 (4080.07, 8068.06) |
Erythema of eyelid | 57 (6.8%) | Eye pain | 56 (4.3%) | 20.47 (15.66, 26.77) |
Reduced visual acuity | 44 (5.2%) | Conjunctival hemorrhage | 41 (3.2%) | 233.96 (170.41, 321.2) |