Table 2.
Safety Overview at Week 104 (SAS)
| No. of Patients (%) | Early-T&E (n = 135) | Late-T&E (n = 136) | Randomization Failure (n = 16) |
| Any TEAE | 114 (84.4) | 112 (82.4) | 12 (75.0) |
| Mild | 40 (29.6) | 29 (21.3) | 4 (25.0) |
| Moderate | 58 (43.0) | 58 (42.6) | 7 (43.8) |
| Severe | 16 (11.9) | 25 (18.4) | 1 (6.3) |
| Ocular TEAE (study eye) | 75 (55.6) | 75 (55.1) | 5 (31.3) |
| Any ocular TEAE related to the study drug (study eye) | 6 (4.4) | 4 (2.9) | 0 |
| Any TEAE related to the injection procedure | 41 (30.4) | 37 (27.2) | 2 (12.5) |
| Any TEAE related to procedures required by the protocol | 6 (4.4) | 7 (5.1) | 0 |
| Any serious TEAE | 29 (21.5) | 35 (25.7) | 3 (18.8) |
| Treatment-emergent deaths | 1 (0.7) | 2 (1.5) | 0 |
| Any serious TEAE related to the study drug | 0 | 2 (1.5)* | 2 (12.5)† |
| Any serious TEAE related to the injection procedure | 0 | 0 | 0 |
| Any serious TEAE related to other procedures required by the protocol | 0 | 0 | 0 |
| Any serious ocular TEAE (study eye) | 0 | 4 (2.9) | 0 |
| Discontinuation of the study drug because of TEAEs | 2 (1.5) | 5 (3.7) | 2 (12.5) |
| Discontinuation of the study drug because of serious TEAEs | 0 | 3 (2.2) | 1 (6.3) |
| APTC | 2 (1.5) | 5 (3.7) | 2 (12.5) |
| Any deaths‡ | 3 (2.2) | 4 (2.9) | 0 |
*
Gastrointestinal hemorrhage (n = 1) and pulmonary embolism (n = 1).
†
Cerebrovascular accident (n = 1) and acute myocardial infarction (n = 1).
‡
Three deaths were treatment-emergent (acute cor pulmonale; acute hepatic failure, acute kidney injury, hypovolemic shock, ileus, and multiple organ dysfunction syndrome; and aortic dissection/pericardial hemorrhage), and none were considered related to IVT-AFL.
APTC, Antiplatelet Trialists' Collaboration; SAS, safety analysis set.