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Table 2 Treatment emergent adverse effects in the study participants

From: The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson’s disease: a randomized, double-blind, double-dummy, parallel-group study

Characteristic

Pramipexole ER

Pramipexole IR

Total

n=234

n=239

n=473

Patients with any AE

161(68.8)

176(73.6)

337(71.2)

  Severe AEs

5(2.1)

9(3.8)

14(3.0)

  Drug-related AEs

117(50)

126(52.7)

243(51.4)

  AEs leading to discontinuation

11(4.7)

12(5.0)

23(4.9)

  Serious AEs

6(2.6)

13(5.4)

19(4.0)

Nervous system disorders

96(41.0)

88(36.8)

184(38.9)

  Somnolence

51(21.8)

35(14.6)

86(18.2)

  Dizziness

30(12.8)

31(13.0)

61(12.9)

  Dyskinesia

12(5.1)

18(7.5)

30(6.3)

  Tremor

4(1.7)

6(2.5)

10(2.1)

  PD

3(1.3)

9(3.8)

12(2.5)

Gastrointestinal disorders

60(25.6)

58(24.3)

108(22.8)

  Nausea

20(8.5)

17(7.1)

37(7.8)

  Constipation

17(7.3)

20(8.4)

37(7.8)

  Abdominal discomfort

3(1.3)

7(2.9)

10(2.1)

  Upper abdominal pain

6(2.6)

6(2.5)

12(2.5)

  Vomiting

5(2.1)

5(2.1)

10(2.1)

Eye disorders

11(4.7)

8(3.3)

19(4.0)

Vascular disorders

8(3.4)

11(4.6)

19(4.0)

  Orthostatic hypotension

5(2.1)

4(1.7)

9(1.9)

  Hypotension

1(0.4)

5(2.1)

6(1.3)