Table 3.
Adverse events.
| Amantadine (N = 23) | Placebo (N = 29) | |
|---|---|---|
| Cardiac disorders | 3 (13%) | 2 (6.9%) |
| Gastrointestinal disorders | 0 (0%) | 1 (3.4%) |
| General disorders and administration site conditions | 4 (17.4%) | 1 (3.4%) |
| Infections and infestations | 1 (4.3%) | 3 (10.3%) |
| Injury, poisoning and procedural complication | 0 (0%) | 1 (3.4%) |
| Nervous system disorders | 0 (0%) | 1 (3.4%) |
| Psychiatric disorders | 1 (4.3%) | 0 (0%) |
| Renal and urinary disorders | 0 (0%) | 1 (3.4%) |
| Respiratory, thoracic and mediastinal disorders | 11 (47.8%) | 14 (48.3%) |
| Vascular disorders | 2 (8.7%) | 5 (17.2%) |
| No data | 1 (4.3%) | 0 (0%) |
| Major adverse cardiovascular events | 1 (5%) | 2 (6.9%) |
| Death | 10 (43.5%) | 7 (24.1%) |
| Association with treatment | ||
| Unlikely | 20 (87%) | 24 (82.8%) |
| Unknown | 1 (4.3%) | 3 (10.3%) |
| Likely | 2 (8.7%) | 2 (6.9%) |
| SAEs likely associated with treatment | ||
| Cardiac disorders | 1 (50%) | 1 (50%) |
| Gastrointestinal disorders | 0 (0%) | 1 (50%) |
| Psychiatric disorders | 1 (50%) | 0 (0%) |
| Major adverse cardiovascular events | 0 (0%) | 1 (50%) |