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Table 4 Treatment-emergent adverse events with a ≥ 1.0% frequency of occurrence in either galcanezumab dose-group

From: Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

 

Integrated double-blind studies

All galcanezumab exposures

Placebo

N = 1451

GMB 120 mg

N = 705

GMB 240 mg

N = 730

GMB 120 mg

N = 991

GMB 240 mg

N = 1285

%

EAIR

(95% CI)

%

EAIR

(95% CI)

%

EAIR

(95% CI)

%

EAIR

(95% CI)

%

EAIR

(95% CI)

Injection site paina

9.5

 

10.1

 

11.6

 

11.0

 

9.6

 

Nasopharyngitisb

6.5

18.19 (14.70,22.26)

7.4

20.13 (15.04,26.40)

4.3c

11.85 (8.05,16.82)

9.4

20.13 (16.25,24.66)

8.5

16.55 (13.59,19.97)

Upper respiratory tract infection

4.1

11.52 (8.79,14.83)

4.4

11.88 (8.07,16.86)

4.9

13.70 (9.60,18.97)

6.8

14.30 (11.08,18.16)

7.0

13.47 (10.83,16.56)

Injection site reactiona

1.0

 

3.1d

 

6.2d

 

5.2

 

6.5

 

Dizziness

2.8

7.85 (5.63,10.65)

2.8

7.65 (4.67,11.82)

2.7

7.61 (4.65,11.75)

2.8

5.90 (3.92,8.53)

3.3

6.24 (4.50,8.44)

Injection site erythemaa

1.4

 

2.8c

 

4.0d

 

3.2

 

4.4

 

Sinusitis

2.1

5.88 (3.99,8.34)

2.8

7.59 (4.64,11.73)

2.6

7.18 (4.32,11.21)

4.1

8.62 (6.18,11.69)

3.9

7.39 (5.48,9.74)

Urinary tract infection

2.3

6.29 (4.33,8.83)

2.7

7.20 (4.33,11.24)

2.5

6.78 (4.02,10.72)

2.6

5.42 (3.54,7.94)

3.8

7.23 (5.35,9.56)

Fatigue

2.3

6.49 (4.50,9.07)

2.4

6.49 (3.78,10.39)

2.2

6.07 (3.47,9.86)

2.2

4.61 (2.89,6.98)

2.7

5.03 (3.48,7.03)

Injection site pruritusa

0.1

 

2.1d

 

3.3d

 

2.3

 

2.8

 

Neck pain

1.5

3.97 (2.46,6.07)

2.1

5.65 (3.16,9.32)

0.8

2.25 (0.82,4.89)

1.7

3.53 (2.06,5.66)

1.7

3.22 (2.02,4.87)

Abdominal pain

1.7

4.56 (2.92,6.79)

1.8

4.92 (2.62,8.41)

0.8

2.24 (0.82,4.88)

1.9

3.95 (2.38,6.17)

1.3

2.48 (1.44,3.97)

Cough

1.3

3.59 (2.16,5.61)

1.7

4.53 (2.34,7.90)

1.8

4.88 (2.60,8.35)

1.8

3.74 (2.22,5.92)

2.5

4.68 (3.20,6.61)

Oropharyngeal pain

0.9

2.46 (1.31,4.20)

1.4

3.77 (1.81,6.94)

1.6

4.51 (2.33,7.87)

1.9

3.95 (2.38,6.17)

2.1

3.95 (2.61,5.75)

Bronchitis

1.2

3.21 (1.87,5.15)

1.3

3.38 (1.55,6.42)

1.5

4.13 (2.06,7.39)

1.8

3.72 (2.21,5.88)

2.7

4.98 (3.45,6.95)

Influenza

2.3

6.46 (4.47,9.02)

1.1

3.01 (1.30,5.93)

2.7

7.55 (4.61,11.66)

2.3

4.79 (3.04,7.19)

4.1

7.69 (5.74,10.08)

Constipation

0.6

1.51 (0.65,2.97)

1.0

2.64 (1.06,5.44)

1.5c

4.14 (2.07,7.40)

1.3

2.70 (1.44,4.61)

1.3

2.48 (1.44,3.96)

Migraine

1.0

2.64 (1.44,4.43)

1.0

2.62 (1.05,5.41)

1.6

4.50 (2.32,7.86)

0.8

1.65 (0.71,3.25)

1.7

3.21 (2.01,4.86)

Rash

1.2

3.22 (1.87,5.15)

1.1

3.02 (1.30,5.94)

1.4

3.76 (1.80,6.91)

1.8

3.73 (2.21,5.90)

2.0

3.65 (2.36,5.39)

Weight increased

0.8

2.27 (1.17,3.96)

1.3

3.38 (1.55,6.42)

0.8

2.24 (0.82,4.88)

1.9

3.95 (2.38,6.17)

1.4

2.62 (1.55,4.15)

Influenza-like illness

0.6

1.51 (0.65,2.97)

0.9

2.25 (0.83,4.90)

1.1

3.00 (1.29,5.90)

0.9

1.86 (0.85,3.53)

1.6

2.92 (1.78,4.51)

Injection site bruisinga

0.6

 

0.6

 

1.4

 

1.2

 

1.6

 

Pruritus (not related to injection site)

0.3

0.75 (0.20,1.93)

0.7

1.88 (0.61,4.38)

1.2c

3.37 (1.54,6.40)

1.4

2.90 (1.59,4.87)

1.3

2.47 (1.44,3.95)

Vertigo

0.2

0.56 (0.12,1.65)

0.7

1.88 (0.61,4.38)

1.2c

3.39 (1.55,6.43)

1.0

2.07 (0.99,3.80)

1.1

2.04 (1.11,3.42)

Dyspepsia

0.6

1.70 (0.78,3.22)

0.7

1.88 (0.61,4.38)

1.1

3.00 (1.30,5.92)

0.9

1.86 (0.85,3.52)

1.1

2.03 (1.11,3.41)

Hypertension

1.0

2.83 (1.58,4.67)

1.1

3.01 (1.30,5.93)

0.7

1.87 (0.61,4.36)

1.1

2.27 (1.14,4.07)

0.9

1.74 (0.90,3.05)

Anxiety

0.9

2.45 (1.31,4.19)

1.3

3.39 (1.55,6.44)

0.4

1.12 (0.23,3.27)

1.7

3.53 (2.06,5.65)

0.9

1.74 (0.90,3.04)

Injection site swellinga

0.1

 

1.1d

 

0.6c

 

1.2

 

0.8

 

Viral infection

0.8

2.07 (1.04,3.71)

1.1

3.01 (1.30,5.93)

0.6

1.49 (0.41,3.82)

1.1

2.27 (1.13,4.06)

0.5

1.01 (0.41,2.09)

Nasal congestion

0.6

1.51 (0.65,2.97)

0.4

1.12 (0.23,3.28)

1.1

3.00 (1.30,5.91)

0.6

1.24 (0.45,2.69)

0.9

1.60 (0.80,2.85)

  1. Abbreviations: CI Confidence interval, EAIR Exposure-adjusted incidence rate, GMB Galcanezumab, N Number of patients in the analysis population; n, number of patients in specific category
  2. aCommon adverse events related to injection sites are not included in EAIR analyses as they do not satisfy the constant hazard assumption of EAIR calculation
  3. bEvents occurred in the galcanezumab 240 mg dose group less frequently than placebo
  4. cP < 0.05 compared with placebo
  5. dP < 0.001 compared with placebo
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