AE, n (%) | Patients (n=586) |
Any AE | 118 (20.1) |
Any TEAE | 118 (20.1) |
Any treatment-related TEAE | 11 (1.9) |
Any ocular TEAE (study eye) | 8 (1.2) |
Most common ocular AE (>0.5%) | |
Vitreous floaters | 11 (1.9) |
Lacrimation increased | 6 (1.0) |
Eye pain | 5 (0.9) |
Photophobia | 4 (0.7) |
Dry eye | 4 (0.7) |
Conjunctivitis | 4 (0.7) |
Eye irritation | 3 (0.5) |
Conjunctival haemorrhage | 3 (0.5) |
Eye pruritus | 3 (0.5) |
Vision blurred | 3 (0.5) |
Visual impairment | 3 (0.5) |
Endophthalmitis | 0 (0.0) |
Any SAE (>0.3%) | 23 (3.9) |
Cancer | 3 (0.5) |
Confusional state/disorientation | 3 (0.5) |
Ischaemic stroke | 3 (0.5) |
Any nonocular TEAE | |
Most common nonocular AE (>0.5%) | |
Product use issue | 17 (2.9) |
Cardiac failure | 5 (0.9) |
Bronchitis | 5 (0.9) |
Drug hypersensitivity | 5 (0.9) |
Injection site pain | 4 (0.7) |
Malaise | 4 (0.7) |
Falls | 4 (0.7) |
Gastroenteritis | 3 (0.5) |
Pneumonia | 3 (0.5) |
Vertigo | 3 (0.5) |
Back pain | 3 (0.5) |
Osteoarthritis | 3 (0.5) |
Ischaemic stroke | 3 (0.5) |
Syncope | 3 (0.5) |
Death (not treatment related) | |
Sudden | 3 (0.5) |
Secondary to AE | 6 (1.0) |
Any TEAE leading to discontinuation | 6 (1.0) |
Transient ischaemic attack | 1 (0.2) |
Any treatment-related TEAE leading to discontinuation | 0 |
AE, adverse event; SAE, serious AE; TEAE, treatment-emergent AE.