Primary SOC-preferred term MedDRA V.13.1 | Ranibizumab | Intravitreal aflibercept | Total | |||
---|---|---|---|---|---|---|
Rq4 n=25 | 2q4 n=26 | 0.5q4 n=25 | 2q8 n=25 | IVT-AFL combined n=76 | n=101 | |
Eye disorders, n (%) | ||||||
Abnormal sensation in eye | 0 | 0 | 1 (4.0) | 0 | 1 (1.3) | 1 (1.0) |
Conjunctival haemorrhage | 6 (24.0) | 3 (11.5) | 6 (24.0) | 7 (28.0) | 16 (21.0) | 22 (21.8) |
Conjunctivitis | 0 | 0 | 0 | 1 (4.0) | 1 (1.3) | 1 (1.0) |
Corneal erosion | 2 (8.0) | 0 | 1 (4.0) | 0 | 1 (1.3) | 3 (3.0) |
Corneal oedema | 0 | 1 (3.8) | 0 | 0 | 1 (1.3) | 1 (1.0) |
Eye pain | 2 (8.0) | 1 (3.8) | 2 (8.0) | 0 | 3 (3.9) | 5 (5.0) |
Eyelid oedema | 2 (8.0) | 0 | 0 | 0 | 0 | 2 (2.0) |
Foreign body sensation in eye | 1 (4.0) | 0 | 1 (4.0) | 0 | 1 (1.3) | 2 (2.0) |
Lacrimation increased | 1 (4.0) | 0 | 0 | 0 | 0 | 1 (1.0) |
Ocular hyperaemia | 2 (8.0) | 2 (7.7) | 0 | 0 | 2 (2.6) | 4 (4.0) |
Punctate keratitis | 0 | 1 (3.8) | 1 (4.0) | 1 (4.0) | 3 (3.9) | 3 (3.0) |
Retinal pigment epithelial tear | 0 | 0 | 0 | 1 (4.0) | 1 (1.3) | 1 (1.0) |
Vitreous floaters | 3 (12.0) | 2 (7.7) | 0 | 1 (4.0) | 3 (3.9) | 6 (5.9) |
Vitreous opacities | 0 | 0 | 1 (4.0) | 0 | 1 (1.3) | 1 (1.0) |
General disorders and administration site conditions, n (%) | ||||||
Injection site pain | 1 (4.0) | 0 | 0 | 0 | 0 | 1 (1.0) |
Investigations, n (%) | ||||||
Intraocular pressure increased | 0 | 0 | 0 | 1 (4.0) | 1 (1.3) | 1 (1.0) |
Surgical and medical procedures, n (%) | ||||||
Intraocular injection* | 1 (4.0) | 0 | 1 (4.0) | 0 | 1 (1.3) | 2 (2.0) |
*Reported term for the adverse event was intraocular air bubble or air retention in the vitreous body.
Note: At each level of patient summarisation, a patient is counted once if the patient reported one or more events.
All events reported by at least 2% of patients are displayed.
IVT-AFL, intravitreal aflibercept; MedDRA, Medical Dictionary for Regulatory Activities; SOC, standard of care; TEAEs, treatment-emergent adverse events.