Efficacy and safety of erenumab in women with a history of menstrual migraine

Table 4 Incidence of adverse events during the double-blind treatment phase

	Placebo N = 83	Erenumab 70 mg N = 68	Erenumab 140 mg N = 81
All treatment-emergent adverse events, n (%)	56 (67.5)	42 (61.8)	42 (51.9)
Grade 3^a	5 (6.0)	2 (2.9)	3 (3.7)
Serious	2 (2.4)	2 (2.9)	2 (2.5)
Leading to discontinuation of study drug	3 (3.6)	1 (1.5)	3 (3.7)
Fatal	0 (0.0)	0 (0.0)	0 (0.0)
Adverse events in ≥2% of patients, n (%)^b
Nasopharyngitis	10 (12.0)	8 (11.8)	8 (9.9)
Upper respiratory tract infection	2 (2.4)	6 (8.8)	5 (6.2)
Nausea	3 (3.6)	3 (4.4)	3 (3.7)
Influenza	1 (1.2)	2 (2.9)	3 (3.7)
Insomnia	0 (0.0)	0 (0.0)	3 (3.7)
Fatigue	1 (1.2)	2 (2.9)	2 (2.5)
Sinusitis	0 (0.0)	2 (2.9)	2 (2.5)
Vomiting	3 (3.6)	1 (1.5)	2 (2.5)
Injection site erythema	1 (1.2)	1 (1.5)	2 (2.5)
Urinary tract infection	5 (6.0)	2 (2.9)	1 (1.2)
Headache	0 (0.0)	2 (2.9)	1 (1.2)
Cardiovascular events, n (%)^c	0 (0.0)	0 (0.0)	0 (0.0)

Adverse events were graded using CTCAE version 4.03. All serious adverse events were single-occurrence events
Abbreviations: CTCAE Common Terminology Criteria for Adverse Events
^aThere were no grade 4 adverse events
^bIn any of the treatment groups
^cBased on the following search criteria: ischemic central nervous system vascular conditions, ischemic heart disease, and peripheral arterial disease

ISSN: 1129-2377