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 3

Incidence of selected AEs over 2 years (safety set, first-treated eye).

Preferred term	Ranibizumab 0.5 mg; total, 𝑛 (%); (𝑁=755)	95% CI*; (LL%, UL%)
Total	21 (2.8)	(1.7, 4.2)
Intraocular pressure; increased	14 (1.9)	(1.0, 3.1)
Vitreous haemorrhage	3 (0.4)	(0.1, 1.2)
Retinal tears	2 (0.3)	(0.0, 1.0)
Endophthalmitis	1 (0.1)	(0.0, 0.7)
Uveitis	1 (0.1)	(0.0, 0.7)
Cataract traumatic	0	(0.0, 0.5)
Retinal detachment	0	(0.0, 0.5)

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).
Special event-preferred terms are presented in the descending order of frequency.
AEs occurring only during the safety observation period are included.
A patient with multiple occurrences of an AE is counted only once in the preferred term category.
AE: adverse event; CI: confidence interval; LL: lower limit; UL: upper limit.