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Table 5 Common treatment-emergent adverse events by concurrent prophylaxis use in patients with chronic migraine

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

 Concurrent prophylaxis useNo concurrent prophylaxis useInteraction
p-valuea
Placebo
(N = 82)
GMB 120 mg
(N = 37)
GMB 240 mg
(N = 43)
Placebo
(N = 476)
GMB 120 mg
(N = 236)
GMB 240 mg
(N = 239)
n (%)n (%)n (%)n (%)n (%)n (%)
Patients with ≥ 1 TEAE42 (51.22)21 (56.76)22 (51.16)237 (49.79)138 (58.47)138 (57.74)0.751
Common TEAE
 Injection site pain2 (2.44)4 (10.81)1 (2.33)22 (4.62)13 (5.51)19 (7.95)0.162
 Nasopharyngitis4 (4.88)3 (8.11)1 (2.33)22 (4.62)14 (5.93)8 (3.35)0.875
 Injection site reaction1 (1.22)0 (0.00)1 (2.33)9 (1.89)8 (3.39)14 (5.86)0.839
 Upper respiratory tract infection2 (2.44)1 (2.70)1 (2.33)11 (2.31)8 (3.39)8 (3.35)0.970
 Back pain1 (1.22)1 (2.70)0 (0.00)13 (2.73)8 (3.39)2 (0.84)0.887
 Fatigue1 (1.22)1 (2.70)0 (0.00)9 (1.89)5 (2.12)6 (2.51)0.689
 Injection site erythema1 (1.22)1 (2.70)2 (4.65)4 (0.84)3 (1.27)11 (4.60)0.777
 Abdominal pain2 (2.44)2 (5.41)0 (0.00)7 (1.47)4 (1.69)4 (1.67)0.629
 Diarrhea2 (2.44)1 (2.70)1 (2.33)7 (1.47)2 (0.85)5 (2.09)0.776
 Sinusitis1 (1.22)0 (0.00)2 (4.65)4 (0.84)4 (1.69)6 (2.51)0.800
 Urinary tract infection2 (2.44)0 (0.00)2 (4.65)5 (1.05)6 (2.54)2 (0.84)0.249
 Neck pain1 (1.22)1 (2.70)0 (0.00)7 (1.47)6 (2.54)0 (0.00)0.773
 Migraine1 (1.22)0 (0.00)1 (2.33)4 (0.84)5 (2.12)3 (1.26)0.718
 Influenza like illness2 (2.44)1 (2.70)0 (0.00)1 (0.21)4 (1.69)4 (1.67)0.274
 Arthralgia0 (0.00)0 (0.00)2 (4.65)5 (1.05)1 (0.42)3 (1.26)0.471
 Oropharyngeal pain0 (0.00)0 (0.00)1 (2.33)3 (0.63)2 (0.85)4 (1.67)0.898
 Injection site pruritus0 (0.00)0 (0.00)0 (0.00)1 (0.21)0 (0.00)7 (2.93)0.473
 Pyrexia0 (0.00)1 (2.70)0 (0.00)2 (0.42)4 (1.69)1 (0.42)0.932
  1. Abbreviations: GMB Galcanezumab, N Number of subjects in safety population, n Number of subjects within each specific category, TEAE Treatment-emergent adverse events
  2. aP-values: TEAE indicator (Y/N) = treatment, baseline medication overuse, concurrent prophylaxis use, and treatment by subgroup