Table 7.
All‐Causality Treatment‐Emergent Adverse Events Experienced by >1 Patient Overall, by MedDRA System Organ Class and Preferred Terms; Safety Analysis Set
| System Organ Class | Placebo | CBD | Total |
|---|---|---|---|
| Preferred Term | (n = 4), n (%) | (n = 16), n (%) | (n = 20), n (%) |
| Subjects experiencing any AEs | 2 (50.0) | 13 (81.3) | 15 (75.0) |
| Gastrointestinal disorders | 1 (25.0) | 8 (50.0) | 9 (45.0) |
| Diarrheaa | 1 (25.0) | 6 (37.5) | 7 (35.0) |
| Nausea | 0 | 3 (18.8) | 3 (15.0) |
| Vomiting | 0 | 3 (18.8) | 3 (15.0) |
| Nervous system disorders | 0 | 9 (56.3) | 9 (45.0) |
| Dizziness | 0 | 2 (12.5) | 2 (10.0) |
| Sedation | 0 | 2 (12.5) | 2 (10.0) |
| Somnolence | 0 | 2 (12.5) | 2 (10.0) |
| Skin and subcutaneous tissue disorders | 0 | 6 (37.5) | 6 (30.0) |
| Dermatitis | 0 | 2 (12.5) | 2 (10.0) |
AE, treatment‐emergent adverse event; CBD, cannabidiol; MedDRA, Medical Dictionary for Regulatory Activities.
a
MedDRA preferred term “diarrhoea.”