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Table 3 TEAEs with incidence of ≥ 3.0% in any erenumab group (safety analysis set), by preferred term

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 at least one AE

265 (44.4)

227 (44.2)

167 (43.7)

394 (44.0)

659 (44.1)

Upper respiratory tract infection

19 (3.2)

23 (4.5)

15 (3.9)

38 (4.2)

57 (3.8)

Viral upper respiratory tract infection

24 (4.0)

23 (4.5)

14 (3.7)

37 (4.1)

61 (4.1)

Constipation

6 (1.0)

16 (3.1)

15 (3.9)

31 (3.5)

37 (2.5)

Injection-site pain

10 (1.7)

22 (4.3)

9 (2.4)

31 (3.5)

41 (2.7)

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 at least one AE

207 (49.2)

150 (42.1)

118 (42.9)

268 (42.5)

475 (45.2)

Viral upper respiratory tract infection

23 (5.5)

15 (4.2)

8 (2.9)

23 (3.6)

46 (4.4)

Upper respiratory tract infection

8 (1.9)

12 (3.4)

2 (0.7)

14 (2.2)

22 (2.1)

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 at least one AE

109 (41.6)

93 (43.5)

80 (50.6)

173 (46.5)

282 (44.5)

Viral upper respiratory tract infection

11 (4.2)

10 (4.7)

10 (6.3)

20 (5.4)

31 (4.9)

Upper respiratory tract infection

6 (2.3)

9 (4.2)

4 (2.5)

13 (3.5)

19 (3.0)

Constipation

3 (1.1)

4 (1.9)

7 (4.4)

11 (3.0)

14 (2.2)

Injection-site pain

2 (0.8)

3 (1.4)

5 (3.2)

8 (2.2)

10 (1.6)

Oropharyngeal pain

3 (1.1)

3 (1.4)

5 (3.2)

8 (2.2)

11 (1.7)

Dizziness

1 (0.4)

0

5 (3.2)

5 (1.3)

6 (0.9)

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 at least one AE

41 (59.4)

15 (39.5)

17 (48.6)

32 (43.8)

73 (51.4)

Fatigue

2 (2.9)

2 (5.3)

2 (5.7)

4 (5.5)

6 (4.2)

Upper respiratory tract infection

2 (2.9)

3 (7.9)

1 (2.9)

4 (5.5)

6 (4.2)

Alopecia

0

0

2 (5.7)

2 (2.7)

2 (1.4)

Back pain

0

0

2 (5.7)

2 (2.7)

2 (1.4)

Injection-site pain

0

0

2 (5.7)

2 (2.7)

2 (1.4)

Ligament sprain

0

2 (5.3)

0

2 (2.7)

2 (1.4)

Musculoskeletal stiffness

0

2 (5.3)

0

2 (2.7)

2 (1.4)

Sinusitis

2 (2.9)

2 (5.3)

0

2 (2.7)

4 (2.8)

Viral upper respiratory tract infection

4 (5.8)

2 (5.3)

0

2 (2.7)

6 (4.2)

  1. Data pooled from the phase 2 CM, STRIVE, ARISE, LIBERTY, and EMPOwER studies (safety analysis set). The summary shows TEAEs with onset day within the first 3 months (91 days) from the first administration of erenumab/placebo. Preferred terms are sorted in descending frequency of AEs in the 70/140 mg column and then alphabetically. A participant with multiple AEs is counted only once in the “at least one AE” row. A participant with multiple AEs with the same preferred term is counted only once for that preferred term
  2. Abbreviations: AEs Adverse events, CM Chronic migraine, TEAE Treatment-emergent adverse event