Table 2.
Most frequent SAEs and AEs over 12 months
| Ranibizumab pooled | Sham | |
|---|---|---|
| N | 102 | 49 |
| SAEs | ||
| Ocular SAEs | ||
| Total | 4 (3.9) | 1 (2.0) |
| Vitreous hemorrhage* | 1 (1.0) | 0 (0.0) |
| Retinal ischemia | 1 (1.0) | 0 (0.0) |
| Retinal artery occlusion* | 1 (1.0) | 0 (0.0) |
| Endophthalmitis* | 2 (2.0) | 0 (0.0) |
| Retinal detachment | 0 (0.0) | 1 (2.0) |
| Nonocular SAEs | ||
| Total | 14 (13.7) | 8 (16.3) |
| Infections and infestations† | 2 (2.0) | 3 (6.1) |
| Urinary bladder cancer | 1 (2.0) | 0 (0.0) |
| AEs | ||
| Ocular AEs | ||
| Total | 80 (78.4) | 28 (57.1) |
| Conjunctival hemorrhage* | 23 (22.5) | 7 (14.3) |
| Eye pain* | 18 (17.6) | 10 (20.4)‡ |
| Nonocular AEs | ||
| Total | 64 (62.7) | 32 (65.3) |
| Nasopharyngitis | 10 (9.8) | 1 (2.0) |
| Hypertension | 7 (6.9) | 4 (8.2) |
| Potentially related to systemic VEGF inhibition | ||
| Total | 14 (13.7) | 6 (12.2) |
| Arterial thromboembolic events§ | 3 (2.9) | 2 (4.1) |
| Hypertension | 9 (8.8) | 5 (10.2) |
| Nonocular hemorrhage | 2 (2.0) | 0 (0.0) |
Data are n (%). Additional safety data are presented in supplementary Tables 3, 5, and 6 (available in an online appendix).
*Suspected to be related to study drug/procedure.
†Infections and infestations include gastroenteritis viral, infected epidermal cyst, cellulitis, diabetic gangrene, and gastroenteritis.
‡One event documented after start of treatment with nonstudy medication (marketed ranibizumab).
§Myocardial infarction (1 in sham and ranibizumab), retinal artery occlusion (1 in ranibizumab), transient ischemic attack (1 in ranibizumab), and angina pectoris (1 in sham).