TABLE 4.
Summary of treatment‐emergent adverse events (TEAEs) in patients ≥50 years of age (safety population)
Eptinezumab 100 mg (n = 132) | Eptinezumab 300 mg (n = 127) | Placebo (n = 126) | |
---|---|---|---|
Patients with any TEAE, n (%) | 62 (46.6%) | 68 (53.5%) | 66 (52.4%) |
Mild | 26 (19.5%) | 24 (18.9%) | 25 (19.8%) |
Moderate | 32 (24.1%) | 42 (33.1%) | 36 (28.6%) |
Severe | 4 (3.0%) | 2 (1.6%) | 4 (3.2%) |
Life‐threatening | 0 | 0 | 1 (0.8%) |
Most common TEAEs (≥ 2% of total patients), n (%) | |||
Nasopharyngitis | 7 (5.3%) | 11 (8.7%) | 6 (4.8%) |
Upper respiratory tract infection | 6 (4.5%) | 10 (7.9%) | 8 (6.3%) |
Urinary tract infection | 4 (3.0%) | 7 (5.5%) | 3 (2.4%) |
Dizziness | 4 (3.0%) | 5 (3.9%) | 3 (2.4%) |
Fatigue | 5 (3.8%) | 4 (3.1%) | 2 (1.6%) |
Sinusitis | 2 (1.5%) | 3 (2.4%) | 5 (4.0%) |
Back pain | 3 (2.3%) | 3 (2.4%) | 3 (2.4%) |
Patients with any TEAE leading to treatment discontinuation, n (%) | 2 (1.5%) | 1 (0.8%) | 4 (3.2%) |
Patients with any TEAE related to study drug, n (%) | 14 (10.5%) | 18 (14.2%) | 13 (10.3%) |
Patients with ≥1 serious adverse event, n (%) | 2 (1.5%) | 1 (0.8%) | 3 (2.4%) |
Syncope | 1 (0.8%) | 0 | 1 (0.8%) |
Apnea | 0 | 0 | 1 (0.8%) |
Breast cancer | 0 | 1 (0.8%) | 0 |
Cellulitis | 0 | 0 | 1 (0.8%) |
Chronic obstructive pulmonary disease | 0 | 0 | 1 (0.8%) |
Depression suicidal | 1 (0.8%) | 0 | 0 |
Gastric ulcer | 1 (0.8%) | 0 | 0 |
Hematemesis | 1 (0.8%) | 0 | 0 |
Migraine | 0 | 0 | 1 (0.8%) |
Tibia fracture | 1 (0.8%) | 0 | 0 |