Table 2.
Treatment emergent adverse effects in the study participants
| 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) |