TABLE 4.
Reported adverse events by participants (n = 129)
Adverse events | Mild | Moderate | Severe | Life‐threatening /disabling | Total (%) |
---|---|---|---|---|---|
Amnesia (memory loss) | 1 | 0 | 0 | 0 | 1 (0.78%) |
Anorexia (lack of appetite) | 0 | 1 | 0 | 0 | 1 (0.78%) |
Anxiety | 1 | 0 | 0 | 0 | 1 (0.78%) |
Blurred vision | 1 | 0 | 0 | 0 | 1 (0.78%) |
Cognitive disturbance | 0 | 0 | 1 | 0 | 1 (0.78%) |
Concentration impairment | 0 | 1 | 0 | 0 | 1 (0.78%) |
Constipation | 3 | 1 | 0 | 0 | 4 (3.10%) |
Coordination/balance/speech | 1 | 1 | 0 | 0 | 2 (1.55%) |
Dizziness | 0 | 2 | 1 | 0 | 3 (2.33%) |
Dry mouth | 1 | 0 | 0 | 0 | 1 (0.78%) |
Fall | 0 | 2 | 0 | 0 | 2 (1.55%) |
Fatigue | 0 | 0 | 2 | 0 | 2 (1.55%) |
Headache | 0 | 0 | 1 | 0 | 1 (0.78%) |
Increased seizures | 0 | 1 | 0 | 0 | 1 (0.78%) |
Insomnia (inability to sleep) | 0 | 0 | 0 | 1 | 1 (0.78%) |
Nausea | 3 | 0 | 0 | 0 | 3 (2.33%) |
Somnolence (sleepy/drowsy) | 0 | 4 | 0 | 0 | 4 (3.10%) |
Spasticity | 0 | 0 | 1 | 0 | 1 (0.78%) |
Total | 11 (8.53%) | 13 (10.08%) | 6 (4.65%) | 1 (0.78%) | 31 (24.03%) |