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Table 2 Incidence of adverse events (AEs) reported in ≥3% of all patients during the 2-year maintenance (safety population)

From: Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch

 

Number of patients (%)

 

Year 1 (n = 290)

Year 2 (n = 220)

Patients with AEs

218 (75.2)

131 (59.6)

Number of AEs

630

263

Most frequent AEsa

  

   Any application site disorderb

100 (34.5)

36 (16.4)

   Nasopharyngitis

25 (8.6)

9 (4.1)

   Back pain

20 (6.9)

10 (4.5)

   Erythema

19 (6.6)

2 (0.9)

   Nausea

14 (4.8)

2 (0.9)

   Pruritus

11 (3.8)

2 (0.9)

   Insomnia

11 (3.8)

1 (0.5)

   Hypertension

10 (3.4)

4 (1.8)

   Fatigue

9 (3.1)

5 (2.3)

   Bronchitis

9 (3.1)

5 (2.3)

   Sleep disorder

9 (3.1)

5 (2.3)

Patients with serious AEs

21 (7.2)

21 (9.5)

Number of serious AEs

24

22

  1. a Incidence in ≥3% of all patients. b Includes preferred terms application site erythema, application site reaction, application site pruritus, and other related terms with lower frequency (e.g., inflammation)