TABLE 3.
Adverse events
| Fremanezumab | Placebo (n = 117) | |||
|---|---|---|---|---|
| Monthly (n = 121) | Quarterly (n = 118) | Total (n = 239) | ||
| Patients with at least one TEAEa | 69 (57.0) | 74 (62.7) | 143 (59.8) | 77 (65.8) |
| Patients with at least one potentially drug‐related TEAE | 32 (26.4) | 37 (31.4) | 69 (28.9) | 28 (23.9) |
| Patients with at least one serious TEAE | 0 | 0 | 0 | 0 |
| Patients with any TEAEs leading to discontinuation of the trial | 1 (0.8) | 0 | 1 (0.4) | 1 (0.9) |
| Death | 0 | 0 | 0 | 0 |
| Patients with adverse events reported in >2% of patients in any group | ||||
| Injection‐site reactions | 31 (25.6) | 35 (29.7) | 66 (27.6) | 25 (21.4) |
| Erythema | 19 (15.7) | 14 (11.9) | 33 (13.8) | 15 (12.8) |
| Hemorrhage | 1 (0.8) | 4 (3.4) | 5 (2.1) | 1 (0.9) |
| Induration | 18 (14.9) | 14 (11.9) | 32 (13.4) | 12 (10.3) |
| Pain | 11 (9.1) | 16 (13.6) | 27 (11.3) | 7 (6.0) |
| Pruritus | 7 (5.8) | 2 (1.7) | 9 (3.8) | 0 |
| Swelling | 4 (3.3) | 2 (1.7) | 6 (2.5) | 0 |
| Infections and infestations | ||||
| Influenza | 6 (5.0) | 2 (1.7) | 8 (3.3) | 1 (0.9) |
| Nasopharyngitis | 17 (14.0) | 15 (12.7) | 32 (13.4) | 16 (13.7) |
| Abdominal pain upper | 1 (0.8) | 3 (2.5) | 4 (1.7) | 0 |
| Diarrhea | 0 | 3 (2.5) | 3 (1.3) | 0 |
| Nausea | 1 (0.8) | 0 | 1 (0.4) | 3 (2.6) |
| Musculoskeletal pain | 0 | 3 (2.5) | 3 (1.3) | 0 |
| Dizziness | 0 | 1 (0.8) | 1 (0.4) | 3 (2.6) |
| Headache | 2 (1.7) | 2 (1.7) | 4 (1.7) | 4 (3.4) |
| Migraine | 0 | 0 | 0 | 3 (2.6) |
| Eczema | 3 (2.5) | 1 (0.8) | 4 (1.7) | 0 |
| Protocol‐defined adverse events of special interest | ||||
| Cardiovascular events | 2 (1.7) | 0 | 2 (0.8) | 3 (2.6) |
| Hepatic enzyme increased | 1 (0.8) | 0 | 1 (0.4) | 1 (0.9) |
| Hepatic function abnormal | 2 (1.7) | 0 | 2 (0.8) | 1 (0.9) |
| Hy's law eventsb | 0 | 0 | 0 | 0 |
| Ophthalmic events of at least moderate severity | 0 | 0 | 0 | 0 |
| Anaphylaxis | 0 | 0 | 0 | 0 |
| Severe hypersensitivity reactions | 0 | 0 | 0 | 0 |
Adverse events were collected by coding in MedDRA version 22.0.
a
Treatment‐emergent adverse events, any adverse events that occurred after treatment started.
b
Defined as aspartate aminotransferase or alanine aminotransferase ≥3 × upper limit of normal (ULN) and total bilirubin ≥2 × ULN or International Normalized Ratio (INR) >1.5.