Table 5 Summary of treatment-emergent adverse events (TEAEs) leading to discontinuation that were considered related to study drug
Eptinezumab | Placebo | ||||||
|---|---|---|---|---|---|---|---|
Patients, n (%) | 1000 mg (n = 81) | 300 mg (n = 823) | 100 mg (n = 701) | 30 mg (n = 341) | 10 mg (n = 130) | All (N = 2076) | (N = 791) |
Hypersensitivity | 0 | 10 (1.2) | 1 (0.1) | 4 (1.2) | 0 | 15 (0.7) | 0 |
Alopecia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.1) |
Peripheral swelling | 0 | 0 | 0 | 1 (0.3) | 0 | 1 (< 0.1) | 0 |
Blood pressure increased | 0 | 0 | 1 (0.1) | 0 | 0 | 1 (< 0.1) | 0 |
Hypertension | 0 | 0 | 1 (0.1) | 0 | 0 | 1 (< 0.1) | 0 |
Dermatitis bullous | 0 | 0 | 1 (0.1) | 0 | 0 | 1 (< 0.1) | 0 |
Headache (worsening of) | 0 | 1 (0.1) | 0 | 0 | 0 | 1 (< 0.1) | 0 |
Erythema | 0 | 0 | 1 (0.1) | 0 | 0 | 1 (< 0.1) | 0 |
Infusion-site erythema | 0 | 1 (0.1) | 0 | 0 | 0 | 1 (< 0.1) | 0 |
Anaphylactic reaction | 0 | 1 (0.1) | 0 | 0 | 0 | 1 (< 0.1) | 0 |