Table 2

Ocular injection-related TEAEs in the study eye (≥2% of patients)

Primary SOC-preferred term MedDRA V.13.1	Ranibizumab	Intravitreal aflibercept				Total
Primary SOC-preferred term MedDRA V.13.1	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.