| |
Eptinezumab 100 mg
|
Eptinezumab 300 mg
|
Eptinezumab 1000 mg
|
Placebo
|
|---|
|
Patients with at least 1 cardiovascular risk factor, n (%)
|
N = 350
|
N = 316
|
N = 41
|
N = 382
|
|---|
|
Any TEAE
|
196 (56.0)
|
187 (59.2)
|
22 (53.7)
|
220 (57.6)
|
|
Cardiac or Vascular TEAEs
|
13 (3.7)
|
14 (4.4)
|
4 (9.8)
|
19 (5.0)
|
|
Increased blood pressure
|
5 (1.4)
|
3 (0.9)
|
0
|
2 (0.5)
|
|
Hypertension
|
2 (0.6)
|
1 (0.3)
|
0
|
5 (1.3)
|
|
Hot flush
|
0
|
3 (0.9)
|
0
|
0
|
|
Palpitations
|
1 (0.3)
|
1 (0.3)
|
0
|
3 (0.8)
|
|
Syncope
|
2 (0.6)
|
2 (0.6)
|
0
|
3 (0.8)
|
|
Tachycardia
|
0
|
2 (0.6)
|
0
|
1 (0.3)
|
|
Chest pain
|
0
|
0
|
1 (2.4)
|
1 (0.3)
|
|
ECG QT prolongation
|
0
|
0
|
2 (4.9)
|
1 (0.3)
|
|
Flushing
|
0
|
1 (0.3)
|
0
|
1 (0.3)
|
|
Sinus tachycardia
|
1 (0.3)
|
0
|
0
|
0
|
|
Increased systolic blood pressure
|
1 (0.3)
|
0
|
0
|
0
|
|
Abnormal ECG Q wave
|
0
|
0
|
1 (2.4)
|
0
|
|
Increased heart rate
|
0
|
1 (0.3)
|
0
|
0
|
|
Hypotension
|
1 (0.3)
|
0
|
0
|
0
|
|
Atrial fibrillation
|
0
|
0
|
0
|
1 (0.3)
|
|
Prehypertension
|
0
|
0
|
0
|
1 (0.3)
|
|
Patients with at least 2 cardiovascular risk factors, n (%)
|
N = 97
|
N = 83
|
N = 7
|
N = 112
|
|
Any TEAE
|
54 (55.7)
|
51 (61.4)
|
4 (57.1)
|
69 (61.6)
|
|
Cardiac or Vascular TEAEs
|
8 (8.2)
|
4 (4.8)
|
0
|
8 (7.1)
|
|
Increased blood pressure
|
2 (2.1)
|
1 (1.2)
|
0
|
1 (0.9)
|
|
Hypertension
|
2 (2.1)
|
1 (1.2)
|
0
|
4 (3.6)
|
|
Syncope
|
2 (2.1)
|
1 (1.2)
|
0
|
2 (1.8)
|
|
Palpitations
|
1 (1.0)
|
0
|
0
|
0
|
|
Hot flush
|
0
|
1 (1.2)
|
0
|
0
|
|
Sinus tachycardia
|
1 (1.0)
|
0
|
0
|
0
|
|
Atrial fibrillation
|
0
|
0
|
0
|
1 (0.9)
|
- ECG Electrocardiogram, TEAE Treatment-emergent adverse event
