Table 5.

Treatment-Emergent Cardiovascular Adverse Events in Patients with Cardiovascular Risk Factors at Baseline

	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