Table 3 Safety outcomes at Month 24
Safety population (N = 588) | Total n (%) |
|---|---|
Any TEAE | 226 (38.4) |
Any treatment-related TEAE | 59 (10.0) |
Ocular | 54 (9.2) |
Non-ocular | 5 (0.9) |
Any ocular TEAE | 136 (23.1) |
Most common ocular AE | |
Lack of efficacy | 37 (6.3) |
Vitreous floaters | 16 (2.7) |
Lacrimation increased | 10 (1.7) |
Visual acuity reduced | 9 (1.5) |
Retinal pigment epithelium detachment | 9 (1.5) |
Any non-ocular TEAE | 123 (20.9) |
Most common non-ocular AE | |
Inappropriate schedule of drug administration | 18 (3.1) |
Bronchitis | 11 (1.9) |
Fall | 7 (1.2) |
Malaise | 6 (1.0) |
Influenza | 5 (0.9) |
Discontinuation due to TEAE | 72 (12.2) |
Discontinuation due to treatment-related TEAE | 40 (6.8) |
Any serious TEAE | 64 (10.9) |
Ocular | 9 (1.5) |
Non-ocular | 59 (10.0) |
Serious TEAE (> 0.5%) | |
Transient ischemic attack | 4 (0.7) |
Death | 5 (0.9) |