Table 2 Most frequent TEAEs in ≥5% of the safety population of any treatment groups a
Adverse event, n (%) | DA-naive | DA-exposed | ||||
|---|---|---|---|---|---|---|
Placebo (n = 195) | GEn 600 mg (n = 133) | GEn 1200 mg (n = 217) | Placebo (n = 50) | GEn 600 mg (n = 30) | GEn 1200 mg (n = 52) | |
Any event | 149 (76) | 105 (79) | 187 (86) | 34 (68) | 27 (90) | 40 (77) |
Somnolence | 12 (6) | 25 (19) | 54 (25) | 0 | 7 (23) | 7 (14) |
Dizziness | 9 (5) | 20 (15) | 44 (20) | 2 (4) | 2 (7) | 15 (29) |
Headache | 22 (11) | 12 (9) | 36 (17) | 5 (10) | 7 (23) | 4 (8) |
Nasopharyngitis | 10 (5) | 13 (10) | 17 (8) | 6 (12) | 1 (3) | 4 (8) |
Nausea | 8 (4) | 5 (4) | 15 (7) | 4 (8) | 4 (13) | 4 (8) |
Fatigue | 10 (5) | 5 (4) | 15 (7) | 1 (2) | 3 (10) | 3 (6) |
Diarrhea | 10 (5) | 3 (2) | 7 (3) | 2 (4) | 3 (10) | 3 (6) |
Upper respiratory tract infection | 7 (4) | 6 (5) | 5 (2) | 2 (4) | 3 (10) | 1 (2) |
Dry mouth | 4 (2) | 4 (3) | 11 (5) | 1 (2) | 1 (3) | 1 (2) |
Constipation | 6 (3) | 0 | 7 (3) | 2 (4) | 3 (10) | 3 (6) |
Insomnia | 6 (3) | 7 (5) | 4 (2) | 1 (2) | 1 (3) | 2 (4) |
Irritability | 3 (2) | 2 (2) | 8 (4) | 0 | 4 (13) | 3 (6) |
Back pain | 6 (3) | 4 (3) | 6 (3) | 1 (2) | 2 (7) | 1 (2) |
Sinusitis | 5 (3) | 2 (2) | 6 (3) | 1 (2) | 3 (10) | 1 (2) |
Increased weight | 3 (2) | 2 (2) | 7 (3) | 2 (4) | 2 (7) | 2 (4) |