Table 4.
Treatment-Emergent Cardiovascular Adverse Events
| Eptinezumab 100 mg | Eptinezumab 300 mg | Eptinezumab 1000 mg | Placebo | |
|---|---|---|---|---|
| Patients, n (%) | N = 701 | N = 695 | N = 81 | N = 791 |
| Cardiac disorders | 6 (0.9) | 8 (1. 2) | 2 (2.5) | 8 (1.0) |
| Bradycardia | 0 | 2 (0.3) | 0 | 0 |
| Palpitations | 1 (0.1) | 2 (0.3) | 0 | 3 (0.4) |
| Tachycardia | 1 (0.1) | 2 (0.3) | 0 | 1 (0.1) |
| Atrial fibrillation | 0 | 1 (0.1) | 0 | 1 (0.1) |
| Atrioventricular block first degree | 2 (0.3) | 1 (0.1) | 0 | 1 (0.1) |
| Bundle branch block right | 0 | 0 | 1 (1.2) | 1 (0.1) |
| Nodal rhythm | 0 | 0 | 1 (1.2) | 0 |
| Sinus bradycardia | 0 | 0 | 0 | 1 (0.1) |
| Sinus tachycardia | 1 (0.1) | 0 | 0 | 0 |
| Supraventricular extrasystoles | 1 (0.1) | 0 | 0 | 0 |
| Investigationsa | 37 (5.3) | 28 (4.0) | 10 (12.3) | 39 (4.9) |
| Increased blood pressure | 7 (1.0) | 3 (0.4) | 1 (1.2) | 5 (0.6) |
| Increased heart rate | 0 | 1 (0.1) | 0 | 0 |
| Increased systolic blood pressure | 1 (0.1) | 0 | 0 | 0 |
| Abnormal electrocardiogram Q wave | 1 (0.1) | 0 | 1 (1.2) | 0 |
| Prolonged electrocardiogram QT | 0 | 0 | 3 (3.7) | 1 (0.1) |
| Vascular disorders | 11 (1.6) | 10 (1.4) | 1 (1.2) | 8 (1.0) |
| Hot flush | 2 (0.3) | 4 (0.6) | 1 (1.2) | 0 |
| Hypertension | 4 (0.6) | 3 (0.4) | 0 | 6 (0.8) |
| Flushing | 1 (0.1) | 2 (0.3) | 0 | 1 (0.1) |
| Hypotension | 1 (0.1) | 1 (0.1) | 0 | 0 |
| Prehypertension | 0 | 0 | 0 | 1 (0.1) |
aNot limited to CV-related investigations. CV Cardiovascular