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Table 5 TEAEs causing study drug discontinuation across age groups, by preferred term (safety analysis set)

From: Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

Aged < 40 years, n (%)

Placebo (n = 597)

Erenumab 70 mg (n = 514)

Erenumab 140 mg (n = 382)

Erenumab 70 + 140 mg (n = 896)

Total (N = 1493)

Number of participants with ≥ 1 AE causing study drug discontinuation

5 (0.8)

6 (1.2)

4 (1.0)

10 (1.1)

15 (1.0)

Palpitations

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Ventricular extrasystoles

0

0

1 (0.3)

1 (0.1)

1 (0.1)

Abdominal pain upper

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Dyspepsia

0

0

1 (0.3)

1 (0.1)

1 (0.1)

Nausea

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Vomiting

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Injection-site pruritus

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Injection-site rash

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Hypersensitivity

1 (0.2)

0

0

0

1 (0.1)

Arthralgia

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Pain in extremity

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Dizziness

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Headache

1 (0.2)

0

0

0

1 (0.1)

Pregnancy

1 (0.2)

1 (0.2)

0

1 (0.1)

2 (0.1)

Initial insomnia

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Mood swings

0

0

1 (0.3)

1 (0.1)

1 (0.1)

Nervousness

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Panic attack

1 (0.2)

0

0

0

1 (0.1)

Metrorrhagia

0

1 (0.2)

0

1 (0.1)

1 (0.1)

Rash maculo-papular

0

0

1 (0.3)

1 (0.1)

1 (0.1)

Alopecia

1 (0.2)

0

0

0

1 (0.1)

Aged 40–49 years, n (%)

Placebo (n = 421)

Erenumab 70 mg (n = 356)

Erenumab 140 mg (n = 275)

Erenumab 70 + 140 mg (n = 631)

Total (N = 1052)

Number of participants with ≥ 1 AE causing study drug discontinuation

3 (0.7)

5 (1.4)

3 (1.1)

8 (1.3)

11 (1.0)

Palpitations

0

0

1 (0.4)

1 (0.2)

1 (0.1)

Vertigo positional

0

1 (0.3)

0

1 (0.2)

1 (0.1)

Oral pain

0

0

1 (0.4)

1 (0.2)

1 (0.1)

Fatigue

1 (0.2)

0

1 (0.4)

1 (0.2)

2 (0.2)

Allergy to arthropod sting

0

1 (0.3)

0

1 (0.2)

1 (0.1)

Pain in extremity

1 (0.2)

0

0

0

1 (0.1)

Hypoaesthesia

1 (0.2)

0

0

0

1 (0.1)

Affect lability

0

1 (0.3)

0

1 (0.2)

1 (0.1)

Metrorrhagia

0

0

1 (0.4)

1 (0.2)

1 (0.1)

Mechanical urticaria

0

1 (0.3)

0

1 (0.2)

1 (0.1)

Aged 50–59 years, n (%)

Placebo (n = 262)

Erenumab 70 mg (n = 214)

Erenumab 140 mg (n = 158)

Erenumab 70 + 140 mg (n = 372)

Total (N = 634)

Number of participants with ≥ 1 AE causing study drug discontinuation

2 (0.8)

2 (0.9)

3 (1.9)

5 (1.3)

7 (1.1)

Vertigo positional

0

0

1 (0.6)

1 (0.3)

1 (0.2)

Constipation

0

0

1 (0.6)

1 (0.3)

1 (0.2)

Gastrooesophageal reflux disease

1 (0.4)

0

0

0

1 (0.2)

Fatigue

0

1 (0.5)

0

1 (0.3)

1 (0.2)

Vestibular neuronitis

0

0

1 (0.6)

1 (0.3)

1 (0.2)

Arthralgia

0

1 (0.5)

0

1 (0.3)

1 (0.2)

Cough

1 (0.4)

0

0

0

1 (0.2)

Dyspnoea

1 (0.4)

0

0

0

1 (0.2)

Alopecia

1 (0.4)

0

0

0

1 (0.2)

Aged ≥ 60 years, n (%)

Placebo (n = 69)

Erenumab 70 mg (n = 38)

Erenumab 140 mg (n = 35)

Erenumab 70 + 140 mg (n = 73)

Total (N = 142)

Number of participants with ≥ 1 AE causing study drug discontinuation

1 (1.4)

0

1 (2.9)

1 (1.4)

2 (1.4)

Nausea

0

0

1 (2.9)

1 (1.4)

1 (0.7)

Erythema

1 (1.4)

0

0

0

1 (0.7)

  1. Data pooled from phase 2 CM, STRIVE, ARISE, LIBERTY, and EMPOwER studies (safety analysis set). The summary contains TEAEs with onset day within the first 3 months (91 days) from the first administration of erenumab or placebo. A participant with multiple AEs within a primary system organ class is counted only once in the total row. A participant with multiple occurrences of an AE under one treatment is counted only once in this AE category for that treatment. Preferred terms are sorted in descending order of frequency in the 70/140 mg column, and then alphabetically
  2. Abbreviations: AE Adverse event, CM Chronic migraine, SAE Serious AE, TEAE Treatment-emergent AE
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The Journal of Headache and Pain

ISSN: 1129-2377

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