Table 4.
All-causality treatment-emergent adverse events experienced by more than one subject per treatment group, by MedDRA preferred term, in the multiple dose arm of the trial (safety analysis set)
| SOC (MedDRA PT) | Placebo (n = 6) | Cannabidiol, mg | |
|---|---|---|---|
| 750 (n = 9) | 1500 (n = 9) | ||
| Subjects experiencing any TEAE | 5 (83.3) | 9 (100.0) | 9 (100.0) |
| Gastrointestinal disorders | 3 (50.0) | 6 (66.7) | 9 (100.0) |
| Diarrhea | 0 | 4 (44.4) | 8 (88.9) |
| Nausea | 1 (16.7) | 3 (33.3) | 5 (55.6) |
| Abdominal discomfort | 1 (16.7) | 3 (33.3) | 1 (11.1) |
| Abdominal pain | 0 | 2 (22.2) | 2 (22.2) |
| Flatulence | 1 (16.7) | 0 | 2 (22.2) |
| Nervous system disorders | 2 (33.3) | 6 (66.7) | 9 (100.0) |
| Headache | 0 | 4 (44.4) | 4 (44.4) |
| Somnolence | 2 (33.3) | 2 (22.2) | 4 (44.4) |
| Dizziness | 0 | 0 | 3 (33.3) |
| Presyncope | 0 | 2 (22.2) | 1 (11.1) |
| Dizziness, postural | 0 | 0 | 2 (22.2) |
| General disorders and administration site conditions | 3 (50.0) | 2 (22.2) | 6 (66.7) |
| Fatigue | 2 (33.3) | 1 (11.1) | 1 (11.1) |
| Feeling cold | 0 | 0 | 2 (22.2) |
| Skin and subcutaneous tissue disorders | 1 (16.7) | 2 (2.2) | 3 (33.3) |
| Dermatitis contact | 1 (16.7) | 2 (22.2) | 0 |
| Rash | 0 | 0 | 2 (22.2) |
| Musculoskeletal and connective tissue disorders | 1 (16.7) | 0 | 4 (44.4) |
| Myalgia | 1 (16.7) | 0 | 3 (33.3) |
| Infections and infestations | 0 | 2 (22.2) | 0 |
| Nasopharyngitis | 0 | 2 (22.2) | 0 |
| Psychiatric disorders | 0 | 0 | 2 (22.2) |
| Insomnia | 0 | 0 | 2 (22.2) |
Data are expressed as n (%)
MedDRA PT Medical Dictionary for Regulatory Activities preferred term, SOC system organ class, TEAE treatment-emergent adverse event