A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study

Table 6

Patients with frequent (≥1%) ocular and nonocular AEs over 2 years (safety set, first-treated eye).

Preferred term	Ranibizumab 0.5 mg total, 𝑛 (%); (𝑁=755)	95% CI*; (LL%, UL%)
Ocular AEs
Total	255 (33.8)	(30.4, 37.3)
Conjunctival; haemorrhage	58 (7.7)	(5.9, 9.8)
Eye irritation	25 (3.3)	(2.2, 4.8)
Cataract	24 (3.2)	(2.0, 4.7)
Conjunctivitis	22 (2.9)	(1.8, 4.4)
Eye pain	21 (2.8)	(1.7, 4.2)
Vitreous floaters	18 (2.4)	(1.4, 3.7)
Retinal haemorrhage	17 (2.3)	(1.3, 3.6)
Intraocular pressure; increased	14 (1.9)	(1.0, 3.1)
Ocular hypertension	14 (1.9)	(1.0, 3.1)
Conjunctivitis allergic	10 (1.3)	(0.6, 2.4)
Injection site discharge	10 (1.3)	(0.6, 2.4)
Retinal pigment; epithelial tear	10 (1.3)	(0.6, 2.4)
Blepharitis	9 (1.2)	(0.5, 2.3)
Glaucoma	8 (1.1)	(0.5, 2.1)
Posterior capsule; opacification	8 (1.1)	(0.5, 2.1)
Nonocular AEs
Total	236 (31.3)	(28.0, 34.7)
Hypertension	19 (2.5)	(1.5, 3.9)
Influenza	17 (2.3)	(1.3, 3.6)
Diabetes mellitus	10 (1.3)	(0.6, 2.4)
Nasopharyngitis	10 (1.3)	(0.6, 2.4)
Urinary tract infection	10 (1.3)	(0.6, 2.4)
Hypercholesterolemia	9 (1.2)	(0.5, 2.3)

Safety set was defined as all those patients who were treated with at least one dose of ranibizumab and who had at least one safety assessment after study entry and no protocol deviations that warranted exclusion.
*Exact Binomial (Clopper-Pearson).
AEs occurring only during the safety observation period are included.
Preferred terms are presented in the descending order of frequency.
A patient with multiple occurrences of an AE is counted only once in the preferred term category.
A patient with multiple AEs is counted only once in the total row.
AE: adverse event; CI: confidence interval; LL: lower limit; UL: upper limit.