Table 5.
All-causality treatment-emergent adverse events experienced by more than one subject per treatment group, by MedDRA preferred term, in the food effect arm of the trial (safety analysis set)
| SOC (MedDRA PT) | Cannabidiol, mg | |
|---|---|---|
| 1500, fasted (n = 12) |
1500, fed (n = 12) |
|
| Subjects experiencing any TEAE | 3 (25.0) | 9 (75.0) |
| Gastrointestinal disorders | 3 (25.0) | 6 (50.0) |
| Nausea | 0 | 4 (33.3) |
| Diarrhea | 3 (25.0) | 0 |
| Abdominal discomfort | 0 | 2 (16.7) |
| Nervous system disorders | 1 (8.3) | 6 (50.0) |
| Headache | 1 (8.3) | 4 (33.3) |
| Somnolence | 1 (8.3) | 3 (25.0) |
| Infections and infestations | 0 | 2 (16.7) |
| Nasopharyngitis | 0 | 2 (16.7) |
Data are expressed as n (%)
MedDRA PT Medical Dictionary for Regulatory Activities preferred term, SOC system organ class, TEAE treatment-emergent adverse event