Table 4.

Proportion of Patients With Ocular and Nonocular Serious Adverse Events for Total Treatment-Naive Patients With nAMD

Preferred Term, n (%)	Treatment-Naive Patients With nAMD, N = 6,241*
Ocular SAEs, total	57 (0.91)
Endophthalmitis	11 (0.18)
Retinal hemorrhage	6 (0.10)
Cataract	6 (0.10)
Retinal pigment epithelial tear	5 (0.08)
Macular hole	5 (0.08)
Retinal detachment	4 (0.06)
nAMD	4 (0.06)
Vitreous hemorrhage	2 (0.03)
Glaucoma	2 (0.03)
Iridocyclitis	2 (0.03)
Blindness	1 (0.02)
Open-angle glaucoma	1 (0.02)
IOP increased	1 (0.02)
Conjunctival hemorrhage	1 (0.02)
Macular fibrosis	1 (0.02)
Subretinal hematoma	1 (0.02)
Dry age-related macular degeneration	1 (0.02)
Eye hemorrhage	1 (0.02)
Retinal injury	1 (0.02)
Retinal vein thrombosis	1 (0.02)
Vitritis	1 (0.02)
Nonocular SAEs, total	462 (7.4)
Pneumonia	29 (0.47)
Cerebrovascular accident	28 (0.45)
Myocardial infarction	17 (0.27)
Atrial fibrillation	16 (0.26)
Fall	15 (0.24)
Angina pectoris	12 (0.19)
Lung neoplasm malignant	11 (0.18)
Cardiac failure	10 (0.16)
Transient ischemic attack	10 (0.16)
Dyspnea	10 (0.16)
Death	52 (0.83)

Primary treated eye set for ocular SAEs; safety set for nonocular SAEs.

n = number of patients.

All ocular SAEs are shown. Nonocular SAEs ≥10 in number are shown, except for death which is mentioned for all patients.

Safety set comprised patients in the enrolled set who were treated with at least one dose of ranibizumab during this study or before start of study and had at least one safety assessment after the first treatment.

A patient with multiple occurrences of an SAE is counted once per preferred term.

Data collected until the last recorded follow-up date were used to perform the analyses (i.e., data for overall duration of the study).

For treatment-naive eyes, the date of first on-study injection with ranibizumab was considered the baseline date.

^*Number of patients at enrollment.