Table 3.
Safety overview (SAF)
| Number of patients (%) | Safety analysis set N = 319 |
|---|---|
| Any AEa | 42 (13.2) |
| Ocular AEsb | 30 (9.4) |
| Vitreous hemorrhage | 8 (2.5) |
| Worsening of diabetic retinopathy | 6 (1.9) |
| Cataract | 3 (0.9) |
| Glaucoma | 3 (0.9) |
| Treatment-related ocular AEs | 6 (1.9) |
| Serious ocular AEs | 6 (1.9) |
| Treatment-related serious ocular AEs | 1 (0.3) |
| Non-ocular AEs | 16 (5.0) |
| Treatment-related non-ocular AEs | 0 |
| Serious non-ocular AEsc | 12 (3.8) |
| Deathsd | 7 (2.2) |
AE adverse event, IVT-AFL intravitreal aflibercept, SAF safety analysis set
aAEs are those reported if they started after the first IVT-AFL injection and not later than 30 days after the last IVT-AFL injection. If no unambiguous allocation is possible because of missing parts of the AE start date, for example, the AE will be treated as an AE (worst case scenario)
bOcular AEs reported by preferred term in ≥ 3 patients
cDeemed to be unrelated to treatment according to the responsible physician
dThe cause of death was unknown for 3 patients; and the 4 other deaths were deemed to be unrelated to treatment according to the responsible physician