Table 3 Tolerability in the 3 Top-recruiting Countries (Czech Republic, United States, and Finland)
AEs, no. (%) | Placebo (n = 126) | Monthly fremanezumab (n = 134) | Quarterly fremanezumab (n = 133) |
|---|---|---|---|
≥ 1 injection-site reaction AE | 15 (12) | 21 (16) | 14 (10) |
≥ 1 AE | 52 (41) | 63 (47) | 55 (41) |
≥ 1 SAE | 3 (2) | 0 | 1 (< 1) |
AEs leading to discontinuation | 2 (2) | 0 | 2 (1) |
AEsa | |||
Injection-site erythema | 6 (5) | 9 (7) | 6 (4) |
Injection-site pain | 4 (3) | 9 (7) | 3 (2) |
Injection-site induration | 3 (2) | 4 (3) | 7 (5) |
Injection-site bruising | 2 (2) | 2 (2) | 2 (1) |
Injection-site pruritus | 2 (2) | 2 (2) | 2 (1) |
Nasopharyngitis | 6 (5) | 6 (5) | 4 (3) |
Upper respiratory tract infection | 1 (< 1) | – | 7 (5) |
Influenza | 0 | 2 (2) | 4 (3) |
Nausea | 2 (2) | 3 (2) | 2 (1) |
Constipation | 2 (2) | 3 (2) | 0 |
Dyspepsia | 2 (2) | 0 | 2 (1) |
Urinary tract infection | 2 (2) | 1 (< 1) | 0 |
Foot fracture | 0 | 2 (2) | 0 |
Road traffic accident | 0 | 2 (2) | 0 |
International normalized ratio increased | 2 (2) | 7 (5) | 2 (1) |
Hemoglobin decreased | 0 | 2 (2) | 0 |
Neck pain | 0 | 1 (< 1) | 3 (2) |
Pain in extremity | 2 (2) | 0 | 3 (2) |
Insomnia | 1 (< 1) | 3 (2) | 3 (2) |
Anxiety | 0 | 1 (< 1) | 2 (1) |
Alopecia | 2 (2) | 1 (< 1) | 1 (< 1) |