Table 3.
Safety overview at week 96 (SAS)
| Number of patients (%) | IVT-AFL-2W adjustment | IVT-AFL-4W adjustment | Randomization failurea |
|---|---|---|---|
| n = 124 | n = 123 | n = 7 | |
| Any TEAE | 85 (68.5) | 86 (69.9) | 5 (71.4) |
| Mild | 62 (50.0) | 55 (44.7) | 2 (28.6) |
| Moderate | 15 (12.1) | 22 (17.9) | 1 (14.3) |
| Severe | 8 (6.5) | 9 (7.3) | 2 (28.6) |
| Ocular TEAE (study eye) | |||
| Any ocular TEAE (study eye) ≥ 2%b | 26 (21.0) | 38 (30.9) | 0 |
| Cataract | 7 (5.6) | 10 (8.1) | 0 |
| Conjunctival hemorrhage | 4 (3.2) | 8 (6.5) | 0 |
| Dry eye | 3 (2.4) | 6 (4.9) | 0 |
| Retinal pigment epithelium tear | 3 (2.4) | 0 | 0 |
| Non-ocular TEAE | |||
| Any non-ocular TEAE ≥ 3%c | 65 (52.4) | 69 (56.1) | 5 (71.4) |
| Constipation | 4 (3.2) | 7 (5.7) | 0 |
| Large intestine polyp | 0 | 4 (3.3) | 0 |
| Nasopharyngitis | 26 (21.0) | 20 (16.3) | 0 |
| Influenza | 2 (1.6) | 4 (3.3) | 0 |
| Contusion | 1 (0.8) | 4 (3.3) | 0 |
| Hypertension | 1 (0.8) | 4 (3.3) | 1 (14.3) |
| Any serious TEAEs | 19 (15.3) | 20 (16.3) | 3 (42.9) |
| Ocular SAE in study eye | 3 (2.4) | 2 (1.6) | 0 |
| Non-ocular SAE | 16 (12.9) | 16 (13.0) | 3 (42.9) |
| Any TEAE leading to discontinuation of study drug | 1 (0.8) | 2 (1.6) | 0 |
| APTC arterial thromboembolic events | 1 (0.8) | 2d (1.6) | 0 |
| Non-fatal myocardial infarction | |||
| Acute myocardial infarction | 0 | 1 (0.8) | 0 |
| Myocardial infarction | 0 | 1 (0.8) | 0 |
| Non-fatal stroke | 0 | 1 (0.8) | 0 |
| Vascular death | 1 (0.8) | 0 | 0 |
| Any death | 2 (1.6) | 1 (0.8) | 0 |
2W/4W 2-/4-week adjustment, APTC Antiplatelet Trialists’ Collaboration, IVT-AFL intravitreal aflibercept, SAE serious adverse event, SAS safety analysis set, TEAE treatment-emergent adverse event
aRandomization failure was due to physician decision (n = 1), logistical difficulties (n = 1), protocol violation (n = 2), and withdrawal by patient (n = 3)
bOcular TEAEs ≥ 2% in either IVT-AFL treatment arm
cNon-ocular TEAEs ≥ 3% in either IVT-AFL treatment arm
dThree events were reported in two patients