Table 5.
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.