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Table 2 Adverse events by treatment group (all causalities) in the double-blind trial

From: Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study

 

Pregabalin (N = 54)

Placebo (N = 53)

AEs, n

167

132

Patients with AEs, n (%)

38 (70.4)

34 (64.2)

Patients with serious AEs, n (%)

1 (1.9)

0

Patients with severe AEs, n (%)

3 (5.6)

3 (5.7)

Discontinuations due to AEs, n (%)

4 (7.4)

4 (7.5)

Common AEsa, n (%)

  

 Dizziness

16 (29.6)

7 (13.2)

 Nausea

12 (22.2)

5 (9.4)

 Headache

10 (18.5)

10 (18.9)

 Weight increased

9 (16.7)

0 (0.0)

 Fatigue

8 (14.8)

4 (7.5)

 Somnolence

5 (9.3)

2 (3.8)

 Oropharyngeal pain

4 (7.4)

2 (3.8)

 Pain in extremity

4 (7.4)

0 (0.0)

 Pyrexia

4 (7.4)

3 (5.7)

 Back pain

3 (5.6)

5 (9.4)

 Upper respiratory tract infection

3 (5.6)

4 (7.5)

 Vomiting

3 (5.6)

4 (7.5)

  1. AE adverse event
  2. a Occurring in at least 5 % of subjects taking pregabalin