Table 2.
Adverse events and discontinuations due to adverse events (safety population)
| Adverse events, n (%) | |||||
| Continuing-Gocovri group (N = 60) | Previous-Placebo group (N = 78) | Participation-Gap group (N = 24) | DBS group (N = 61) | All patients (N = 223) | |
| Summary | |||||
| Any AE | 57 (95.0%) | 70 (89.7%) | 23 (95.8%) | 55 (90.2%) | 205 (91.9%) |
| Study-drug related | 31 (51.7%) | 45 (57.7%) | 16 (66.7%) | 32 (52.5%) | 124 (55.6%) |
| Any SAE | 16 (26.7%) | 21 (26.9%) | 6 (25.0%) | 17 (27.9%) | 60 (26.9%) |
| Study-drug related | 1 (1.7%) | 3 (3.8%) | 0 | 1 (1.6%) | 5 (2.2%) |
| Any leading to study-drug discontinuation or death | 12 (20.0%) | 21 (26.9%) | 6 (25.0%) | 10 (16.4%) | 49 (22.0%) |
| Study-drug related | 4 (6.7%) | 15 (19.2%) | 4 (16.7%) | 8 (13.1%) | 31 (13.9%) |
| By preferred terma | |||||
| Fall | 13 (21.7%) | 29 (37.2%) | 8 (33.3%) | 23 (37.7%) | 73 (32.7%) |
| Hallucination | 15 (25.0%) | 24 (30.8%) | 5 (20.8%) | 10 (16.4%) | 54 (24.2%) |
| Visual | 14 (23.3%) | 24 (30.8%) | 4 (16.7%) | 10 (16.4%) | 52 (23.3%) |
| Auditory | 1 (1.7%) | 1 (1.3%) | 1 (4.2%) | 2 (3.3%) | 5 (2.2%) |
| Peripheral edema | 10 (16.7%) | 12 (15.4%) | 2 (8.3%) | 12 (19.7%) | 36 (16.1%) |
| Constipation | 9 (15.0%) | 12 (15.4%) | 6 (25%) | 3 (4.9%) | 30 (13.5%) |
| Urinary tract infection | 7 (11.7%) | 8 (10.3%) | 3 (12.5%) | 5 (8.2%) | 23 (10.3%) |
| Dizziness | 4 (6.7%) | 10 (12.8%) | 5 (20.8%) | 3 (4.9%) | 22 (9.9%) |
| Nausea | 7 (11.7%) | 8 (10.3%) | 6 (25.0%) | 1 (1.6%) | 22 (9.9%) |
| Insomnia | 8 (13.3%) | 5 (6.4%) | 4 (16.7%) | 4 (6.6%) | 21 (9.4%) |
| Livedo reticularis | 6 (10.0%) | 5 (6.4%) | 3 (12.5%) | 6 (9.8%) | 20 (9.0%) |
| ON and OFF phenomenon | 7 (11.7%) | 4 (5.1%) | 4 (16.7%) | 3 (4.9%) | 18 (8.1%) |
| Dry mouth | 4 (6.7%) | 6 (7.7%) | 4 (16.7%) | 3 (4.9%) | 17 (7.6%) |
aIncludes all preferred terms with an incidence ≥7.5% among all patients. AE, adverse event; DBS, deep brain stimulation; SAE, serious adverse event.