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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 use

No concurrent prophylaxis use

Interaction

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 TEAE

42 (51.22)

21 (56.76)

22 (51.16)

237 (49.79)

138 (58.47)

138 (57.74)

0.751

Common TEAE

 Injection site pain

2 (2.44)

4 (10.81)

1 (2.33)

22 (4.62)

13 (5.51)

19 (7.95)

0.162

 Nasopharyngitis

4 (4.88)

3 (8.11)

1 (2.33)

22 (4.62)

14 (5.93)

8 (3.35)

0.875

 Injection site reaction

1 (1.22)

0 (0.00)

1 (2.33)

9 (1.89)

8 (3.39)

14 (5.86)

0.839

 Upper respiratory tract infection

2 (2.44)

1 (2.70)

1 (2.33)

11 (2.31)

8 (3.39)

8 (3.35)

0.970

 Back pain

1 (1.22)

1 (2.70)

0 (0.00)

13 (2.73)

8 (3.39)

2 (0.84)

0.887

 Fatigue

1 (1.22)

1 (2.70)

0 (0.00)

9 (1.89)

5 (2.12)

6 (2.51)

0.689

 Injection site erythema

1 (1.22)

1 (2.70)

2 (4.65)

4 (0.84)

3 (1.27)

11 (4.60)

0.777

 Abdominal pain

2 (2.44)

2 (5.41)

0 (0.00)

7 (1.47)

4 (1.69)

4 (1.67)

0.629

 Diarrhea

2 (2.44)

1 (2.70)

1 (2.33)

7 (1.47)

2 (0.85)

5 (2.09)

0.776

 Sinusitis

1 (1.22)

0 (0.00)

2 (4.65)

4 (0.84)

4 (1.69)

6 (2.51)

0.800

 Urinary tract infection

2 (2.44)

0 (0.00)

2 (4.65)

5 (1.05)

6 (2.54)

2 (0.84)

0.249

 Neck pain

1 (1.22)

1 (2.70)

0 (0.00)

7 (1.47)

6 (2.54)

0 (0.00)

0.773

 Migraine

1 (1.22)

0 (0.00)

1 (2.33)

4 (0.84)

5 (2.12)

3 (1.26)

0.718

 Influenza like illness

2 (2.44)

1 (2.70)

0 (0.00)

1 (0.21)

4 (1.69)

4 (1.67)

0.274

 Arthralgia

0 (0.00)

0 (0.00)

2 (4.65)

5 (1.05)

1 (0.42)

3 (1.26)

0.471

 Oropharyngeal pain

0 (0.00)

0 (0.00)

1 (2.33)

3 (0.63)

2 (0.85)

4 (1.67)

0.898

 Injection site pruritus

0 (0.00)

0 (0.00)

0 (0.00)

1 (0.21)

0 (0.00)

7 (2.93)

0.473

 Pyrexia

0 (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
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BMC Neurology

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