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 5

Patients with ocular SAEs and frequent nonocular SAEs (≥3 patients) over 2 years (safety set, first-treated eye).

Preferred term	Ranibizumab 0.5 mg; total,  𝑛 (%); (𝑁=755)	95% CI*; (LL%, UL%)
Ocular SAEs
Total	12 (1.6)	(0.8, 2.8)
Retinal haemorrhage	4 (0.5)	(0.1, 1.4)
Retinal pigment; epithelial tear	2 (0.3)	(0.0, 1.0)
Angle closure; glaucoma	1 (0.1)	(0.0, 0.7)
Endophthalmitis	1 (0.1)	(0.0, 0.7)
Glaucoma	1 (0.1)	(0.0, 0.7)
Intraocular pressure; increased	1 (0.1)	(0.0, 0.7)
Macular hole	1 (0.1)	(0.0, 0.7)
Open angle glaucoma	1 (0.1)	(0.0, 0.7)
Optic neuritis	1 (0.1)	(0.0, 0.7)
Visual acuity reduced	1 (0.1)	(0.0, 0.7)
Vitreous haemorrhage	1 (0.1)†	(0.0, 0.7)
Nonocular SAEs
Total	89 (11.8)‡	(9.6, 14.3)
Cerebrovascular; accident	5 (0.7)	(0.2, 1.5)
Chronic obstructive; pulmonary disease	5 (0.7)	(0.2, 1.5)
Hypertension	5 (0.7)	(0.2, 1.5)
Pneumonia	4 (0.5)	(0.1, 1.4)
Cardiac failure	3 (0.4)	(0.1, 1.2)
Colon cancer	3 (0.4)	(0.1, 1.2)
Depression	3 (0.4)	(0.1, 1.2)
Femur fracture	3 (0.4)	(0.1, 1.2)

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).
†Patient discontinued the treatment due to SAE.
‡17 patients discontinued the treatment due to nonocular SAE.
SAEs 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; SAE: serious adverse event; UL: upper limit.