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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 overuse

No medication overuse

Interaction

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 TEAE

169 (47.88)

99 (55.62)

99 (55.93)

110 (53.92)

59 (62.77)

60 (57.69)

0.800

Common TEAE

 Injection site pain

15 (4.25)

9 (5.06)

11 (6.21)

9 (4.41)

8 (8.51)

9 (8.65)

0.734

 Nasopharyngitis

13 (3.68)

11 (6.18)

6 (3.39)

13 (6.37)

6 (6.38)

3 (2.88)

0.597

 Injection site reaction

10 (2.83)

5 (2.81)

12 (6.78)

0 (0.00)

3 (3.19)

3 (2.88)

0.209

 Upper respiratory tract infection

10 (2.83)

6 (3.37)

6 (3.39)

3 (1.47)

3 (3.19)

3 (2.88)

0.795

 Back pain

9 (2.55)

6 (3.37)

2 (1.13)

5 (2.45)

3 (3.19)

0 (0.00)

0.789

 Fatigue

5 (1.42)

3 (1.69)

4 (2.26)

5 (2.45)

3 (3.19)

2 (1.92)

0.771

 Injection site erythema

3 (0.85)

1 (0.56)

6 (3.39)

2 (0.98)

3 (3.19)

7 (6.73)

0.596

 Abdominal pain

7 (1.98)

3 (1.69)

1 (0.56)

2 (0.98)

3 (3.19)

2 (1.92)

0.340

 Diarrhea

7 (1.98)

2 (1.12)

3 (1.69)

2 (0.98)

1 (1.06)

3 (2.88)

0.566

 Sinusitis

2 (0.57)

2 (1.12)

7 (3.95)

3 (1.47)

2 (2.13)

1 (0.96)

0.216

 Urinary tract infection

3 (0.85)

4 (2.25)

2 (1.13)

4 (1.96)

2 (2.13)

1 (0.96)

0.727

 Neck pain

5 (1.42)

4 (2.25)

0 (0.00)

3 (1.47)

3 (3.19)

0 (0.00)

0.946

 Migraine

4 (1.13)

3 (1.69)

3 (1.69)

1 (0.49)

2 (2.13)

1 (0.96)

0.771

 Influenza like illness

2 (0.57)

3 (1.69)

2 (1.13)

1 (0.49)

2 (2.13)

2 (1.92)

0.929

 Arthralgia

4 (1.13)

0 (0.00)

2 (1.13)

1 (0.49)

1 (1.06)

3 (2.88)

0.351

 Oropharyngeal pain

2 (0.57)

1 (0.56)

3 (1.69)

1 (0.49)

1 (1.06)

2 (1.92)

0.922

 Injection site pruritus

0 (0.00)

0 (0.00)

4 (2.26)

1 (0.49)

0 (0.00)

3 (2.88)

0.729

 Pyrexia

1 (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
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BMC Neurology

ISSN: 1471-2377

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