Table 7 Adverse events of eptinezumab versus placebo.

From: Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment

Adverse event

Number of studies

Number of events/participants

I2(%)

Risk ratio(95%CI)

P

Eptinezumab group

Placebo group

Upper respiratory tract infection

5

130/2073

33/965

0

1.49 (1.02–2.18)

0.04

Urinary tract infection

3

41/1380

28/746

0

0.79 (0.49–1.28)

0.34

Tooth abscess

1

3/81

0/82

N/A

7.09 (0.37–135.03)

0.19

Dizziness

4

59/1835

23/723

0

0.85 (0.53–1.36)

0.50

Migraine

3

28/1282

20/569

13

0.60 (0.33–1.09)

0.09

Headache

1

0/81

2/82

N/A

0.20 (0.01–4.15)

0.30

Sciatica

1

2/81

0/82

N/A

5.06 (0.25–103.81)

0.29

Fatigue

3

32/1340

8/602

41

1.92 (0.84–4.39)

0.12

Pyrexia

1

1/81

2/82

N/A

0.51 (0.05–5.47)

0.58

Malaise

1

2/81

0/82

N/A

5.06 (0.25–103.81)

0.29

Dry mouth

1

3/81

0/82

N/A

7.09 (0.37–135.03)

0.19

Nausea and vomiting

6

76/2779

32/1331

0

0.92 (0.61–1.38)

0.70

Back pain

4

25/1578

17/844

0

0.71 (0.38–1.33)

0.28

Arthralgia

2

10/674

4/380

77

1.59 (0.46–5.51)

0.47

Musculoskeletal pain

1

0/81

2/82

N/A

0.2 (0.01–4.15)

0.30

ECG QTcF prolongation

1

3/81

1/82

N/A

3.04 (0.32–28.59)

0.33

Pruritus

2

3/319

0/324

0

4.06 (0.46–36.02)

0.21

Ankle fracture

1

1/81

2/82

N/A

0.51 (0.05–5.47)

0.58

Arthropod bite

1

2/81

0/82

N/A

5.06 (0.25–103.81)

0.29

Hyperkalaemia

1

2/81

0/82

N/A

5.06 (0.25–103.81)

0.29

Sinus congestion

1

0/81

2/82

N/A

0.20 (0.01–4.15)

0.30

Depression

1

0/81

2/82

N/A

0.20 (0.01–4.15)

0.30

Weight loss

1

2/81

0/82

N/A

5.06 (0.25–103.81)

0.29

Nasopharyngitis

3

123/1867

40/709

0

1.20 (0.85–1.71)

0.29

Sinusitis

2

49/1161

20/343

9

0.71 (0.43–1.19)

0.19

Bronchitis

2

34/1161

17/343

0

0.58 (0.33–1.02)

0.06

Cough

2

16/904

7/464

0

0.82 (0.36–1.89)

0.64

Influenza

2

17/904

7/464

0

1.00 (0.41–2.44)

0.99

Diarrhea

2

20/1259

8/520

46

0.97 (0.42–2.25)

0.95

Hypersensitivity

2

21/831

6/540

50

1.92 (0.83–4.42)

0.13

COVID-19

1

37/593

16/298

N/A

1.16 (0.66–2.05)

0.61

Upper abdominal pain

1

2/593

2/298

N/A

0.50 (0.07–3.55)

0.49

Events potentially associated with study drug infusion

2

14/831

4/540

0

2.16 (0.68–6.89)

0.19

Cardiovascular or cerebrovascular disorders

1

13/593

8/298

N/A

0.82 (0.34–1.95)

0.65

Seizures

1

1/593

0/298

N/A

1.51 (0.06–36.96)

0.80

Hepatic events

1

4/593

4/298

N/A

0.50 (0.13–2.00)

0.33

Suicidal ideation and behaviour

1

0/593

1/298

N/A

0.17 (0.01–4.11)

0.27

Dyspnea

1

1/238

0/242

N/A

3.05 (0.12–74.50)

0.49

Rhinitis

1

1/238

0/242

N/A

3.05 (0.12–74.50)

0.49

Syncope

1

1/238

0/242

N/A

3.05 (0.12–74.50)

0.49

Increased transaminase levels

1

1/238

0/242

N/A

3.05 (0.12–74.50)

0.49

Oropharyngeal pain

1

0/238

1/242

N/A

0.34 (0.01–8.28)

0.51

  1. ECG QTcF electrocardiogram corrected QT interval by the fridericia formula, COVID-19 coronavirus disease 2019, N/A not applicable, CI confidence interval.
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