Table 4.
Summary of treatment-emergent adverse events (TEAEs) by MedDRA term and treatment
| System organ class (MedDRA PT) | Cannabidiol, mg/kg | ||||||
|---|---|---|---|---|---|---|---|
| 5 (N = 6) | 10 (N = 6) | 20 (N = 6) | Total (N = 18) | Placebo (N = 6) | All subjects (N = 24) | ||
| Subjects with at least one TEAE | 3 (50%) | 1 (17%) | 3 (50%) | 7 (39%) | 3 (50%) | 10 (42%) | |
| Infections and infestations | – | – | 1 (17%) | 1 (6%) | – | 1 (4%) | |
| Upper respiratory tract infection | – | – | 1 (17%) | 1 (6%) | – | 1 (4%) | |
| Metabolism and nutrition disorders | 1 (17%) | – | – | 1 (6%) | – | 1 (4%) | |
| Increased appetite | 1 (17%) | – | – | 1 (6%) | – | 1 (4%) | |
| Nervous system disorders | 2 (33%) | 1 (17%) | 1 (17%) | 4 (22%) | 1 (17%) | 5 (21%) | |
| Dizziness postural | 1 (17%) | – | – | 1 (6%) | – | 1 (4%) | |
| Headache | 1 (17%) | 1 (17%) | 1 (17%) | 3 (17%) | 1 (17%) | 4 (17%) | |
| Gastrointestinal disorders | – | – | 3 (50%) | 3 (17%) | – | 3 (13%) | |
| Diarrhoea | – | – | 2 (33%) | 2 (11%) | – | 2 (8%) | |
| Nausea | – | – | 1 (17%) | 1 (6%) | – | 1 (4%) | |
| Skin and subcutaneous tissue disorders | 1 (17%) | – | – | 1 (6%) | – | 1 (4%) | |
| Drug eruption | 1 (17%) | – | – | 1 (6%) | – | 1 (4%) | |
| Musculoskeletal and connective tissue disorders | – | – | – | – | 1 (17%) | 1 (4%) | |
| Back pain | – | – | – | – | 1 (17%) | 1 (4%) | |
| General disorders and administration site conditions | – | – | – | – | 1 (17%) | 1 (4%) | |
| Fatigue | – | – | – | – | 1 (17%) | 1 (4%) | |
MedDRA Medical Dictionary for Regulatory Activities preferred term, SOC system organ class, TEAE treatment emergent adverse event