Table 3.
TEAEs at week 13
| No. (%) of patients with AEs | IVT-AFL n = 27 |
Sham/IVT-AFL n = 27 |
Total n = 54 |
|---|---|---|---|
| Any TEAE | 13 (48.1) | 20 (74.1) | 33 (61.1) |
| Ocular TEAEs | 11 (40.7) | 15 (55.6) | 26 (48.1) |
| Commonly reported ocular TEAEs (≥ 5% overall) | |||
| Punctate keratitis | 2 (7.4) | 3 (11.1) | 5 (9.3) |
| Eye pain | 0 | 3 (11.1) | 3 (5.6) |
| Conjunctival hemorrhage | 2 (7.4) | 1 (3.7) | 3 (5.6) |
| Injection-site pain | 2 (7.4) | 1 (3.7) | 3 (5.6) |
| Procedural pain | 3 (11.1) | 0 | 3 (5.6) |
| Nonocular TEAEs | 8 (29.6) | 11 (40.7) | 19 (35.2) |
| Commonly reported nonocular TEAEs (≥ 5% overall) | |||
| Constipation | 1 (3.7) | 2 (7.4) | 3 (5.6) |
| Headache | 1 (3.7) | 2 (7.4) | 3 (5.6) |
| Treatment-related TEAEs | 1 (3.7) | 2 (7.4) | 3 (5.6) |
| SAEs | 3 (11.1) | 3 (11.1) | 6 (11.1) |
| Ocular SAEs in study eye | 2 (7.4) | 1 (3.7) | 3 (5.6) |
| Nonocular SAEs | 1 (3.7) | 2 (7.4) | 3 (5.6) |
| Treatment-related SAEs | 0 | 1 (3.7)a | 1 (1.9) |
| APTC-AEs | 0 | 1 (3.7)a | 1 (1.9) |
AE adverse event, APTC Antiplatelet Trialists’ Collaboration, ATE arterial thromboembolic event, IVT-AFL intravitreal aflibercept, SAE serious adverse event, TEAE treatment-emergent adverse event
aThis APTC-defined ATE was nonfatal myocardial infarction, considered by investigator to be drug related. Patient was randomly assigned to the sham group, and IVT-AFL was given at week 1