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. 2015 Nov 5;5(4):837–845. doi: 10.3233/JPD-150622

Table 5.

Adverse events during conversion to IPX066 (all treated patients)

Variable Conversion Conversion
from from
IR CD-LD CLE
N 450 110
Summary statistics, n (%)
  Any AE 206 (45.8) 34 (30.9)
  Mild 160 (35.6) 26 (23.6)
  Moderate 85 (18.9) 14 (12.7)
  Severe 15 (3.3) 2 (1.8)
  Any serious AE 14 (3.1) 2 (1.8)
  Discontinuation due to AEs 23 (5.1) 1 (0.9)
  Death 2 (0.4) 0
AEs by Preferred Term a , n (%)
  Dyskinesia 25 (5.6) 1 (0.9)
  Nausea 24 (5.3) 8 (7.3)
  Headache 19 (4.2) 2 (1.8)
  Dizziness 17 (3.8) 1 (0.9)
  On and off phenomenon 14 (3.1) 0
  Fall 12 (2.7) 3 (2.7)
  Anxiety 11 (2.4) 1 (0.9)
  Dry mouth 11 (2.4) 0
  Insomnia 11 (2.4) 1 (0.9)
  Constipation 9 (2.0) 1 (0.9)
  Vomiting 7 (1.6) 3 (2.7)
  Upper respiratory tract infection 5 (1.1) 3 (2.7)

aAEs are those reported in ≥2.0% of patients who began conversion to IPX066 in either study, and are listed by Medical Dictionary for Regulatory Activities Version 12.1 Preferred Term. AE, adverse event; CD, carbidopa; CLE, immediate-release carbidopa-levodopa plus entacapone; IR, immediate-release; LD, levodopa.