Table 4 Summary of treatment-emergent adverse events (TEAEs) with incidence of ≥2% of patients in any eptinezumab arm and 2 percentage points greater than placebo
Eptinezumab | Placebo | ||||||
|---|---|---|---|---|---|---|---|
Patients, n (%) | 1000 mg (n = 81) | 300 mg (n = 823) | 100 mg (n = 701) | 30 mg (n = 341) | 10 mg (n = 130) | All (N = 2076) | (N = 791) |
Upper respiratory tract infection | 7 (8.6) | 64 (7.8) | 45 (6.4) | 32 (9.4) | 9 (6.9) | 157 (7.6) | 48 (6.1) |
Nasopharyngitis | 1 (1.2) | 72 (8.7) | 44 (6.3) | 17 (5.0) | 6 (4.6) | 140 (6.7) | 41 (5.2) |
Dizziness | 3 (3.7) | 16 (1.9) | 27 (3.9) | 11 (3.2) | 11 (8.5) | 68 (3.3) | 21 (2.7) |
Fatigue | 3 (3.7) | 24 (2.9) | 20 (2.9) | 9 (2.6) | 2 (1.5) | 58 (2.8) | 13 (1.6) |
Anxiety | 0 | 14 (1.7) | 10 (1.4) | 5 (1.5) | 4 (3.1) | 33 (1.6) | 5 (0.6) |
Pain in extremity | 1 (1.2) | 6 (0.7) | 5 (0.7) | 8 (2.3) | 0 | 20 (1.0) | 2 (0.3) |
Tooth abscess | 3 (3.7) | 4 (0.5) | 3 (0.4) | 2 (0.6) | 1 (0.8) | 13 (0.6) | 3 (0.4) |
Dry mouth | 3 (3.7) | 3 (0.4) | 2 (0.3) | 1 (0.3) | 1 (0.8) | 10 (0.5) | 3 (0.4) |
Sciatica | 2 (2.5) | 2 (0.2) | 5 (0.7) | 1 (0.3) | 0 | 10 (0.5) | 2 (0.3) |
Fall | 1 (1.2) | 3 (0.4) | 2 (0.3) | 0 | 3 (2.3) | 9 (0.4) | 2 (0.3) |
Arthropod bite | 2 (2.5) | 3 (0.4) | 1 (0.1) | 1 (0.3) | 0 | 7 (0.3) | 4 (0.5) |
Weight decreased | 2 (2.5) | 2 (0.2) | 1 (0.1) | 0 | 1 (0.8) | 6 (0.3) | 1 (0.1) |
Electrocardiogram QT prolonged | 3 (3.7) | 0 | 0 | 0 | 0 | 3 (0.1) | 1 (0.1) |