Table 3.
Summary of AEs in STP arm (safety population)
| Number of patients, n (%) | Placebo (n = 2) | CBD (n = 12) |
|---|---|---|
| At least one AE | 0 (0) | 8 (67) |
| AEs leading to discontinuation | 0 (0) | 1 (8) |
| Serious AEs | 0 (0) | 1 (8) |
| Severe AEs | 0 (0) | 1 (8) |
| Death | 0 (0) | 0 (0) |
| AEs reported by ≥ 10% of patients | ||
| Diarrhea | 0 (0) | 5 (42) |
| Fatigue | 0 (0) | 3 (25) |
| Nausea | 0 (0) | 2 (17) |
| ALT increased | 0 (0) | 2 (17) |
| AST increased | 0 (0) | 2 (17) |
| Decreased appetite | 0 (0) | 2 (17) |
AE treatment-emergent adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, CBD cannabidiol, STP stiripentol