Table 3.
All-causality treatment-emergent adverse events experienced by more than one subject per treatment group, by MedDRA preferred term, in the single ascending dose arm of the trial (safety analysis set)
| SOC (MedDRA PT) | Placebo (n = 8) | Cannabidiol, mg | |||
|---|---|---|---|---|---|
| 1500 (n = 6) | 3000 (n = 6) | 4500 (n = 6) | 6000 (n = 6) | ||
| Subjects experiencing any TEAE | 5 (62.5) | 4 (66.7) | 5 (83.3) | 5 (83.3) | 5 (83.3) |
| Gastrointestinal disorders | 4 (50.0) | 1 (16.7) | 5 (83.3) | 4 (66.7) | 4 (66.7) |
| Diarrhea | 2 (25.0) | 0 | 5 (83.3) | 3 (50.0) | 4 (66.7) |
| Abdominal discomfort | 3 (37.5) | 0 | 2 (33.3) | 0 | 0 |
| Nausea | 2 (25.0) | 1 (16.7) | 0 | 1 (16.7) | 1 (16.7) |
| Nervous system disorders | 3 (37.5) | 2 (33.3) | 2 (33.3) | 5 (83.3) | 5 (83.3) |
| Somnolence | 3 (37.5) | 2 (33.3) | 1 (16.7) | 1 (16.7) | 4 (66.7) |
| Headache | 0 | 1 (16.7) | 1 (16.7) | 4 (66.7) | 2 (33.3) |
| Dizziness | 0 | 1 (16.7) | 0 | 1 (16.7) | 2 (33.3) |
| Disturbance in attention | 0 | 2 (33.3) | 0 | 0 | 0 |
Data are expressed as n (%)
MedDRA PT Medical Dictionary for Regulatory Activities preferred term, SOC system organ class, TEAE treatment-emergent adverse event