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%) |