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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 studiesAll 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 paina9.5 10.1 11.6 11.0 9.6 
Nasopharyngitisb6.518.19 (14.70,22.26)7.420.13 (15.04,26.40)4.3c11.85 (8.05,16.82)9.420.13 (16.25,24.66)8.516.55 (13.59,19.97)
Upper respiratory tract infection4.111.52 (8.79,14.83)4.411.88 (8.07,16.86)4.913.70 (9.60,18.97)6.814.30 (11.08,18.16)7.013.47 (10.83,16.56)
Injection site reactiona1.0 3.1d 6.2d 5.2 6.5 
Dizziness2.87.85 (5.63,10.65)2.87.65 (4.67,11.82)2.77.61 (4.65,11.75)2.85.90 (3.92,8.53)3.36.24 (4.50,8.44)
Injection site erythemaa1.4 2.8c 4.0d 3.2 4.4 
Sinusitis2.15.88 (3.99,8.34)2.87.59 (4.64,11.73)2.67.18 (4.32,11.21)4.18.62 (6.18,11.69)3.97.39 (5.48,9.74)
Urinary tract infection2.36.29 (4.33,8.83)2.77.20 (4.33,11.24)2.56.78 (4.02,10.72)2.65.42 (3.54,7.94)3.87.23 (5.35,9.56)
Fatigue2.36.49 (4.50,9.07)2.46.49 (3.78,10.39)2.26.07 (3.47,9.86)2.24.61 (2.89,6.98)2.75.03 (3.48,7.03)
Injection site pruritusa0.1 2.1d 3.3d 2.3 2.8 
Neck pain1.53.97 (2.46,6.07)2.15.65 (3.16,9.32)0.82.25 (0.82,4.89)1.73.53 (2.06,5.66)1.73.22 (2.02,4.87)
Abdominal pain1.74.56 (2.92,6.79)1.84.92 (2.62,8.41)0.82.24 (0.82,4.88)1.93.95 (2.38,6.17)1.32.48 (1.44,3.97)
Cough1.33.59 (2.16,5.61)1.74.53 (2.34,7.90)1.84.88 (2.60,8.35)1.83.74 (2.22,5.92)2.54.68 (3.20,6.61)
Oropharyngeal pain0.92.46 (1.31,4.20)1.43.77 (1.81,6.94)1.64.51 (2.33,7.87)1.93.95 (2.38,6.17)2.13.95 (2.61,5.75)
Bronchitis1.23.21 (1.87,5.15)1.33.38 (1.55,6.42)1.54.13 (2.06,7.39)1.83.72 (2.21,5.88)2.74.98 (3.45,6.95)
Influenza2.36.46 (4.47,9.02)1.13.01 (1.30,5.93)2.77.55 (4.61,11.66)2.34.79 (3.04,7.19)4.17.69 (5.74,10.08)
Constipation0.61.51 (0.65,2.97)1.02.64 (1.06,5.44)1.5c4.14 (2.07,7.40)1.32.70 (1.44,4.61)1.32.48 (1.44,3.96)
Migraine1.02.64 (1.44,4.43)1.02.62 (1.05,5.41)1.64.50 (2.32,7.86)0.81.65 (0.71,3.25)1.73.21 (2.01,4.86)
Rash1.23.22 (1.87,5.15)1.13.02 (1.30,5.94)1.43.76 (1.80,6.91)1.83.73 (2.21,5.90)2.03.65 (2.36,5.39)
Weight increased0.82.27 (1.17,3.96)1.33.38 (1.55,6.42)0.82.24 (0.82,4.88)1.93.95 (2.38,6.17)1.42.62 (1.55,4.15)
Influenza-like illness0.61.51 (0.65,2.97)0.92.25 (0.83,4.90)1.13.00 (1.29,5.90)0.91.86 (0.85,3.53)1.62.92 (1.78,4.51)
Injection site bruisinga0.6 0.6 1.4 1.2 1.6 
Pruritus (not related to injection site)0.30.75 (0.20,1.93)0.71.88 (0.61,4.38)1.2c3.37 (1.54,6.40)1.42.90 (1.59,4.87)1.32.47 (1.44,3.95)
Vertigo0.20.56 (0.12,1.65)0.71.88 (0.61,4.38)1.2c3.39 (1.55,6.43)1.02.07 (0.99,3.80)1.12.04 (1.11,3.42)
Dyspepsia0.61.70 (0.78,3.22)0.71.88 (0.61,4.38)1.13.00 (1.30,5.92)0.91.86 (0.85,3.52)1.12.03 (1.11,3.41)
Hypertension1.02.83 (1.58,4.67)1.13.01 (1.30,5.93)0.71.87 (0.61,4.36)1.12.27 (1.14,4.07)0.91.74 (0.90,3.05)
Anxiety0.92.45 (1.31,4.19)1.33.39 (1.55,6.44)0.41.12 (0.23,3.27)1.73.53 (2.06,5.65)0.91.74 (0.90,3.04)
Injection site swellinga0.1 1.1d 0.6c 1.2 0.8 
Viral infection0.82.07 (1.04,3.71)1.13.01 (1.30,5.93)0.61.49 (0.41,3.82)1.12.27 (1.13,4.06)0.51.01 (0.41,2.09)
Nasal congestion0.61.51 (0.65,2.97)0.41.12 (0.23,3.28)1.13.00 (1.30,5.91)0.61.24 (0.45,2.69)0.91.60 (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