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 4

Selected AEs over 2 years: per injection, per patient-year (first-treated eye), and per treated eye (safety set).

Preferred term	Ranibizumab 0.5 mg; total; (𝑁=755)
AEs per injection*
Total number of injections	4711
Intraocular pressure increased	40 (0.0085)
Vitreous haemorrhage	3 (0.0006)
Retinal tear(s)	2 (0.0004)
Endophthalmitis	1 (0.0002)
Uveitis	1 (0.0002)
Cataract traumatic	0
Retinal detachment	0
AEs per patient-year†
Total number of years	1361
Intraocular pressure increased	40 (0.0294)
Vitreous haemorrhage	3 (0.0022)
Retinal tear(s)	2 (0.0015)
Endophthalmitis	1 (0.0007)
Uveitis	1 (0.0007)
Cataract traumatic	0
Retinal detachment	0
AEs per treated eye‡
Total number of treated eyes	888
Intraocular pressure increased	41 (0.0462)
Vitreous haemorrhage	5 (0.0056)
Retinal tear(s)	2 (0.0023)
Endophthalmitis	1 (0.0011)
Uveitis	1 (0.0011)
Cataract traumatic	0
Retinal detachment	0

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.
*Number of AEs (rate per injection), where rate per injection is calculated as the number of events/total number of injections.
†Number of AEs (rate per year), where rate per patient-year of safety observation is calculated as the number of events/total number of patient-years.
‡Number of AEs (rate per eye), where rate per treated eye is calculated as the number of events/total number of treated eyes.
Preferred terms are presented in the descending order of frequency.
All occurrences of the AE during the safety observation period are included in the AE category (including multiple occurrences per patient).
AE: adverse event.