Table 2.
Treatment-emergent adverse events in the single increasing dose protocol
| Brivaracetam dose (mg) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | 10 | 20 | 40 | 80 | 150 | 300 | 600 | 1000 | 1400 | |
| Number of dosed subjects | 27 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Number of subjects reporting adverse events | 5 | 2 | 1 | 1 | 3 | 3 | 5 | 6 | 6 | 4 |
| Total number of adverse events | 5 | 2 | 1 | 2 | 5 | 3 | 7 | 11 | 9 | 11 |
| Adverse events (n) | ||||||||||
| Blurred vision | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Dizziness | 0 | 0 | 0 | 1 | 1 | 1 | 3 | 4 | 3 | 2 |
| Somnolence | 1 | 0 | 0 | 0 | 3 | 1 | 1 | 3 | 1 | 2 |
| Psychiatric disorders* | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 1 |
*
Agitation, bradyphrenia, disorientation, euphoric mood.