Table 2.
Selection of the most important adverse effects in some clinical studies
| Adverse effect | Leppik20* | Wroe et al21* | Leppik et al19*,& | Shinnar et al22** |
|---|---|---|---|---|
| Number of patients included in the study | N = 1207 | N = 318 | N = 113 | N = 109 |
| Drowsiness or somnolence | 263 (21.8%) | 47 (14.8%) | 15 (13.3%) | 22 (20.2%) |
| Dizziness | 247 (20.5%) | 54 (17%) | 18 (15.9%) | 4 (3.7%) |
| Anorexia or decreased appetite | 201 (16.7%) | 17 (15%) | 20 (18.3%) | |
| Fatigue or tiredness or asthenia | 182 (15.1%) | 39 (12.3%) | 10 (8.8%) | 5 (4.6%) |
| Nausea | 159 (13.2%) | 35 (11%) | 17 (15%) | |
| Headache | 145 (12%) | 74 (23.3%) | 18 (15.9%) | |
| Disturbance in attention or confusional states | 145 (12%) | 12 (10.6%) | ||
| Mental slowing | 138 (11.4%) | |||
| Thinking abnormal | 11 (9.7%) | 5 (4.6%) | ||
| Behavioral changes or epileptic psychosis, irritability, agitation, nervousness, | 133 (11%) | 10 (8.8%) | 9 (8.3%) | |
| Hostility | 9 (8.3%) | |||
| Emotional lability | 6 (5.5%) | |||
| Diplopia | 131 (10.9%) | |||
| Difficulty with memory | 125 (10.4%) | |||
| Weight loss | 43 (13.5%) | |||
| Diarrhea | 33 (10.4%) | |||
| Ataxia | 12 (10.6%) | |||
| Dysarthria | 10 (8.8%) | |||
| Decreased sweating | 8 (7.3%) |
*
Adverse events reported by ≥10% of patients.
&
Adverse events observed during long-term phase only in patients enrolled in the long-term study.
**
Adverse events reported by ≥2% of patients.