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) |