Table 4. Serious Adverse Events in the Modified Intention-to-Treat Population.
Adverse event | No. (%) of patients | |
---|---|---|
Intervention (n = 121) | Control (n = 117) | |
Patients with at least 1 serious adverse event at 30 d | 19 (15.7) | 19 (16.2) |
Intracranial hemorrhage | 0 | 3 (2.6) |
Extracranial hemorrhage | 1 (0.8) | 1 (0.9) |
Stroke progression | 2 (1.7) | 2 (1.7) |
New ischemic stroke | 2 (1.7) | 2 (1.7) |
Allergic reaction | 0 | 0 |
Pneumonia | 1 (0.8) | 3 (2.6) |
Other infection | 1 (0.8) | 2 (1.7) |
Other serious adverse event | 12 (9.9) | 9 (7.7) |