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

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

  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 3a 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)
  1. Adverse events were graded using CTCAE version 4.03. All serious adverse events were single-occurrence events
  2. Abbreviations: CTCAE Common Terminology Criteria for Adverse Events
  3. aThere were no grade 4 adverse events
  4. bIn any of the treatment groups
  5. cBased on the following search criteria: ischemic central nervous system vascular conditions, ischemic heart disease, and peripheral arterial disease