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Table 6 Common treatment-emergent adverse events by medication overuse in patients with chronic migraine

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

 Medication overuseNo medication overuseInteraction
p-valuea
Placebo
(N = 353)
GMB 120 mg
(N = 178)
GMB 240 mg
(N = 177)
Placebo
(N = 204)
GMB 120 mg
(N = 94)
GMB 240 mg
(N = 104)
n (%)n (%)n (%)n (%)n (%)n (%)
Patients with ≥ 1 TEAE169 (47.88)99 (55.62)99 (55.93)110 (53.92)59 (62.77)60 (57.69)0.800
Common TEAE
 Injection site pain15 (4.25)9 (5.06)11 (6.21)9 (4.41)8 (8.51)9 (8.65)0.734
 Nasopharyngitis13 (3.68)11 (6.18)6 (3.39)13 (6.37)6 (6.38)3 (2.88)0.597
 Injection site reaction10 (2.83)5 (2.81)12 (6.78)0 (0.00)3 (3.19)3 (2.88)0.209
 Upper respiratory tract infection10 (2.83)6 (3.37)6 (3.39)3 (1.47)3 (3.19)3 (2.88)0.795
 Back pain9 (2.55)6 (3.37)2 (1.13)5 (2.45)3 (3.19)0 (0.00)0.789
 Fatigue5 (1.42)3 (1.69)4 (2.26)5 (2.45)3 (3.19)2 (1.92)0.771
 Injection site erythema3 (0.85)1 (0.56)6 (3.39)2 (0.98)3 (3.19)7 (6.73)0.596
 Abdominal pain7 (1.98)3 (1.69)1 (0.56)2 (0.98)3 (3.19)2 (1.92)0.340
 Diarrhea7 (1.98)2 (1.12)3 (1.69)2 (0.98)1 (1.06)3 (2.88)0.566
 Sinusitis2 (0.57)2 (1.12)7 (3.95)3 (1.47)2 (2.13)1 (0.96)0.216
 Urinary tract infection3 (0.85)4 (2.25)2 (1.13)4 (1.96)2 (2.13)1 (0.96)0.727
 Neck pain5 (1.42)4 (2.25)0 (0.00)3 (1.47)3 (3.19)0 (0.00)0.946
 Migraine4 (1.13)3 (1.69)3 (1.69)1 (0.49)2 (2.13)1 (0.96)0.771
 Influenza like illness2 (0.57)3 (1.69)2 (1.13)1 (0.49)2 (2.13)2 (1.92)0.929
 Arthralgia4 (1.13)0 (0.00)2 (1.13)1 (0.49)1 (1.06)3 (2.88)0.351
 Oropharyngeal pain2 (0.57)1 (0.56)3 (1.69)1 (0.49)1 (1.06)2 (1.92)0.922
 Injection site pruritus0 (0.00)0 (0.00)4 (2.26)1 (0.49)0 (0.00)3 (2.88)0.729
 Pyrexia1 (0.28)2 (1.12)0 (0.00)1 (0.49)3 (3.19)1 (0.96)0.856
  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 Note: 3 patients in the analysis population had missing medication overuse