Table 6 Open-label period summary of treatment-emergent adverse events presented by treatment sequence group (APTS-OL)
Placebo–eptinezumab 100 mg (n = 81) | Eptinezumab 100 mg–eptinezumab 100 mg (n = 81) | |
|---|---|---|
Patients with TEAEs, n (%) | 38 (46.9) | 34 (42.0) |
Total number of TEAEs | 71 | 74 |
TEAEs occurring in ≥ 2% of patients, n (%) | ||
Migraine | 1 (1.2) | 5 (6.2) |
Covid-19 | 3 (3.7) | 3 (3.7) |
Pyrexia | 0 (0.0) | 3 (3.7) |
Urinary tract infection | 0 (0.0) | 3 (3.7) |
Bronchitis | 1 (1.2) | 2 (2.5) |
Glucose tolerance impaired | 0 (0.0) | 2 (2.5) |
Headache | 0 (0.0) | 2 (2.5) |
Myalgia | 1 (1.2) | 2 (2.5) |
Pharyngotonsillitis | 0 (0.0) | 2 (2.5) |
Dizziness | 3 (3.7) | 1 (1.2) |
Abdominal pain upper | 2 (2.5) | 0 (0.0) |
Diarrhea | 2 (2.5) | 0 (0.0) |
Fatigue | 2 (2.5) | 0 (0.0) |
Hyperlipidemia | 3 (3.7) | 0 (0.0) |
Proteinuria | 2 (2.5) | 0 (0.0) |
Upper respiratory tract infection | 11 (13.6) | 0 (0.0) |
Patients with SAEs, n (%) | 0 (0.0) | 4 (4.9) |
Total number of SAEs | 0 | 7 |
Patients with TEAEs leading to infusion interruption/termination, n (%) | 0 (0.0) | 0 (0.0) |
Total number of TEAEs leading to study drug infusion interruption/termination | 0 | 0 |
Patients with TEAEs leading to withdrawal, n (%) | 1 (1.2) | 1 (1.2) |
Total number of TEAEs leading to withdrawal | 1 | 1 |
Deaths, n (%) | 0 (0.0) | 0 (0.0) |