Table 3.
Proportion of Patients With Ocular and Nonocular Adverse Events for Total Treatment-Naive Patients With nAMD
| Preferred Term, n (%) | Treatment-Naive Patients With nAMD, N = 6,241* |
| Ocular AEs, total | 514 (8.24) |
| Cataract | 113 (1.81) |
| IOP increased | 33 (0.53) |
| Conjunctival hemorrhage | 33 (0.53) |
| Conjunctivitis | 26 (0.42) |
| Eye pain | 22 (0.35) |
| Visual acuity reduced | 22 (0.35) |
| Dry eye | 19 (0.30) |
| Retinal hemorrhage | 19 (0.30) |
| Blepharitis | 17 (0.27) |
| Posterior capsule opacification | 16 (0.26) |
| Glaucoma | 15 (0.24) |
| Vitreous floaters | 14 (0.22) |
| Ocular hypertension | 14 (0.22) |
| Visual impairment | 12 (0.19) |
| Vision blurred | 11 (0.18) |
| Endophthalmitis | 11 (0.18) |
| Corneal abrasion | 10 (0.16) |
| Retinal pigment epithelial tear | 10 (0.16) |
| Nonocular AEs, total | 796 (12.75) |
| Fall | 44 (0.71) |
| Urinary tract infection | 41 (0.66) |
| Lower respiratory tract infection | 40 (0.64) |
| Pneumonia | 34 (0.55) |
| Cerebrovascular accident | 28 (0.45) |
| Hypertension | 23 (0.37) |
| Influenza | 22 (0.35) |
| Atrial fibrillation | 21 (0.34) |
| Bronchitis | 20 (0.32) |
| Dyspnoea | 19 (0.30) |
| Osteoarthritis | 19 (0.30) |
| Nasopharyngitis | 18 (0.29) |
| Myocardial infarction | 17 (0.27) |
| Angina pectoris | 17 (0.27) |
| Cough | 16 (0.26) |
| Dizziness | 15 (0.24) |
| Anaemia | 14 (0.22) |
| Transient ischaemic attack | 14 (0.22) |
| Headache | 13 (0.21) |
| Basal cell carcinoma | 13 (0.21) |
| Cardiac failure | 12 (0.19) |
| Constipation | 11 (0.18) |
| Lung neoplasm malignant | 11 (0.18) |
| Back pain | 10 (0.16) |
| Diarrhoea | 10 (0.16) |
| Pain in extremity | 10 (0.16) |
| Vomiting | 10 (0.16) |
| Sciatica | 10 (0.16) |
Primary treated eye set for ocular AEs; Safety set for nonocular AEs.
n = number of patients.
Ocular and nonocular AEs ≥10 in number are shown.
Safety set comprised patients in the enrolled set who were treated with at least one dose of ranibizumab during this study or before the start of the study and had at least one safety assessment after the first treatment.
A patient with multiple occurrences of an AE is counted once per preferred term.
Data collected until the last recorded follow-up date was 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.