Table 4 Incidence of TEAEs (Safety Set)a
Placebo | Rotigotine low dose | Rotigotine high dose | Total rotigotine | |
|---|---|---|---|---|
(n = 40) | (n = 41) | (n = 41) | (N = 82) | |
Any TEAE, n (%) | 27 (67.5) | 28 (68.3) | 27 (65.9) | 55 (67.1) |
Mild | 12 (30.0) | 16 (39.0) | 14 (34.1) | 30 (36.6) |
Moderate | 13 (32.5) | 9 (22.0) | 12 (29.3) | 21 (25.6) |
Severe | 2 (5.0) | 3 (7.3) | 1 (2.4) | 4 (4.9) |
Serious TEAE, n (%) | 4 (10.0) | 2 (4.9) | 1 (2.4) | 3 (3.7) |
Discontinued due to TEAE, n (%) | 4 (10.0) | 5 (12.2) | 3 (7.3) | 8 (9.8) |
Drug-related TEAEs, n (%) | 18 (45.0) | 19 (46.3) | 18 (43.9) | 37 (45.1) |
Deaths, n (%) | 0 | 0 | 0 | 0 |
Most common TEAEs ≥5 % in any treatment groupb | ||||
Application site reactionsc | 3 (7.5) | 5 (12.2) | 3 (7.3) | 8 (9.8) |
Nausea | 4 (10.0) | 4 (9.8) | 2 (4.9) | 6 (7.3) |
Somnolence | 3 (7.5) | 2 (4.9) | 4 (9.8) | 6 (7.3) |
Depression | 2 (5.0) | 4 (9.8) | 1 (2.4) | 5 (6.1) |
Fall | 2 (5.0) | 3 (7.3) | 2 (4.9) | 5 (6.1) |
Constipation | 1 (2.5) | 2 (4.9) | 3 (7.3) | 5 (6.1) |
Peripheral edema | 1 (2.5) | 2 (4.9) | 3 (7.3) | 5 (6.1) |
Headache | 4 (10.0) | 1 (2.4) | 3 (7.3) | 4 (4.9) |
Dyskinesia | 2 (5.0) | 3 (7.3) | 1 (2.4) | 4 (4.9) |
Fatigue | 2 (5.0) | 2 (4.9) | 1 (2.4) | 3 (3.7) |
Dry mouth | 0 | 0 | 3 (7.3) | 3 (7.3) |
Insomnia | 6 (15.0) | 1 (2.4) | 2 (4.9) | 3 (3.7) |
Suicidal ideation | 3 (7.5) | 1 (2.4) | 0 | 1 (1.2) |
Rash | 2 (5.0) | 1 (2.4) | 0 | 1 (1.2) |
Tremor | 2 (5.0) | 1 (2.4) | 0 | 1 (1.2) |
Dystonia | 2 (5.0) | 0 | 0 | 0 |
Vertigo | 2 (5.0) | 0 | 0 | 0 |
Visual hallucinations | 2 (5.0) | 0 | 0 | 0 |