Table II.
Incidence (%) of AEs reported by ≥ 5% of patients in any group
| Parameter | Overall (n = 309) | Newer (n = 76) | Oldera (n = 233) | Mono (n = 188) | Poly (n = 121) |
|---|---|---|---|---|---|
| Neurological AE [%] | |||||
| Cognitive function disturbance | 40.5 | 30.3 | 43.8** | 31.4 | 54.5*** |
| Psychological problemsb | 36.2 | 31.6 | 37.8 | 32.4 | 42.1 |
| Sedation | 32.7 | 22.4 | 36.1** | 28.2 | 39.7** |
| Headache | 18.4 | 12.0 | 13.6 | 14.4 | 12.4 |
| Tremor | 13.6 | 9.2 | 15.0 | 8.5 | 21.5*** |
| Dizziness | 10.4 | 6.6 | 11.6 | 8.0 | 14.0 |
| Ataxia | 4.5 | 2.6 | 5.2 | 2.7 | 7.4** |
| Dysarthria | 3.6 | 6.6 | 2.6 | 0.5 | 8.3*** |
| Diplopia | 3.2 | 6.6 | 2.1 | 1.6 | 5.8** |
| Systemic AE [%] | |||||
| Gain or loss of weight | 19.4 | 15.8 | 20.6 | 19.7 | 19.0 |
| GI problems | 12.0 | 2.6 | 15.0*** | 8.5 | 15.4** |
| Arthralgia | 8.4 | 5.3 | 9.4 | 10.1 | 5.8 |
| Changes in hair quantity and texture | 7.8 | 5.3 | 8.6 | 6.9 | 9.1 |
| Lack of menstrual cyclec | 5.5 | 9.2 | 4.3 | 4.8 | 6.6 |
a
Also includes patients on 1 newer and 1 older AED
b
Depression, tension/agitation, anger/hostility, vigor/excitability, fatigue/apathy, confusion/thought disorder
c
If applicable
**
p < 0.05
***
p < 0.01