Table 3 Summary of patients with adverse eventsa
Treatment-naïve (n = 42) | Previously treated (n = 270) | All (N = 312) | |
|---|---|---|---|
All adverse events, n (%) | 18 (42.9) | 70 (25.9) | 88 (28.2) |
Treatment-related, n (%) | 11 (26.2) | 37 (13.7) | 48 (15.4) |
Oculara | 11 (26.2) | 37 (13.7) | 48 (15.4) |
Ocular hyperemia | 6 (14.3) | 12 (4.4) | 18 (5.8) |
Dark circles under the eyes | 0 | 6 (2.2) | 6 (1.9) |
Eye pruritus | 1 (2.4) | 4 (1.5) | 5 (1.6) |
Decreased lacrimation | 1 (2.4) | 4 (1.5) | 5 (1.6) |
Eye allergy | 1 (2.4) | 2 (0.7) | 3 (1.0) |
Ocular discomfort | 1 (2.4) | 1 (0.4) | 2 (0.6) |
Eye pain | 1 (2.4) | 0 | 1 (0.3) |
Serious | 0 | 0 | 0 |
Leading to discontinuation, n (%) | 6 (14.3) | 15 (5.6) | 21 (6.7) |