Table 2.
Summary of adverse events
| Characteristics, n (%) | Fremanezumab | ||
|---|---|---|---|
| Monthly (n = 25) | Quarterly (n = 25) | Total (n = 50) | |
| Patients with at least one TEAE | 23 (92.0) | 22 (88.0) | 45 (90.0) |
| Patients with at least one TEAE related to the trial regimen | 11 (44.0) | 6 (24.0) | 17 (34.0) |
| Patients with at least one serious TEAE | 0 | 2 (8.0) | 2 (4.0) |
| Patients with any TEAE leading to discontinuation of the trial | 0 | 2 (8.0) | 2 (4.0) |
| Death | 0 | 0 | 0 |
| Patients with TEAE reported in ≥ 5% of patients in any group | |||
| Injection-site reactions | |||
| Erythema | 7 (28.0) | 5 (20.0) | 12 (24.0) |
| Induration | 3 (12.0) | 2 (8.0) | 5 (10.0) |
| Pain | 1 (4.0) | 3 (12.0) | 4 (8.0) |
| Pruritus | 2 (8.0) | 1 (4.0) | 3 (6.0) |
| Infections and infestations | |||
| Gastroenteritis | 3 (12.0) | 1 (4.0) | 4 (8.0) |
| Influenza | 1 (4.0) | 2 (8.0) | 3 (6.0) |
| Nasopharyngitis | 18 (72.0) | 14 (56.0) | 32 (64.0) |
| Oral herpes | 1 (4.0) | 2 (8.0) | 3 (6.0) |
| Back pain | 1 (4.0) | 2 (8.0) | 3 (6.0) |
| Dysmenorrhea | 2 (8.0) | 1 (4.0) | 3 (6.0) |
| Cough | 1 (4.0) | 2 (8.0) | 3 (6.0) |
TEAE treatment-emergent adverse event