Table 5.
Treatment emergent adverse events with an incidence >1
| Primary system organ class Preferred term* | No. of subjects (%) | No. of subjects (%) | No. of subjects (%) |
|---|---|---|---|
| THC/CBD spray (n = 36) | |||
| Psychiatric disorders | |||
| Euphoric mood | 2 (6) | - | - |
| Nervous system disorders | |||
| Dizziness | 2 (6) | - | - |
| Dizziness postural | 3 (8) | - | - |
| Headache | 5 (14) | - | - |
| Somnolence | 11 (31) | - | - |
| Gastrointestinal disorders | |||
| Nausea | 2 (6) | - | - |
| Rifampicin(n = 12) | THC/CBD spray and Rifampicin(n = 12) | THC/CBD spray(n = 12) | |
| Nervous system disorders | |||
| Dysgeusia | 1 (8) | 0 | 1 (8) |
| Headache | 0 | 1 (8) | 1 (8) |
| Somnolence | 0 | 0 | 2 (17) |
| Ketoconazole(n = 12) | THC/CBD spray and Ketoconazole(n = 11) | THC/CBD spray(n = 12) | |
| Nervous system disorders | |||
| Somnolence | 0 | 4 (36) | 4 (33) |
| Dizziness | 0 | 3 (27) | 2 (17) |
| Lethargy | 0 | 3 (27) | 0 |
| Dysgeusia | 0 | 2 (18) | 0 |
| Headache | 0 | 2 (18) | 0 |
| Somnolence | 0 | 1 (9) | 1 (8) |
| Psychiatric disorders | |||
| Euphoric mood | 0 | 7 (64) | 0 |
| Anxiety | 0 | 1 (9) | 1 (8) |
| Disorientation | 0 | 1 (9) | 1 (8) |
| Omeprazole(n = 12) | THC/CBD spray and Omeprazole(n = 12) | THC/CBD spray(n = 12) | |
| Nervous system disorders | |||
| Dizziness | 0 | 3 (25) | 0 |
| Dizziness postural | 0 | 0 | 2 (17) |
| Headache | 1 (8) | 0 | 4 (33) |
| Somnolence | 0 | 2 (17) | 5 (42) |
| Gastrointestinal disorders | |||
| Dry mouth | 0 | 2 (17) | 1 (8) |
*MedDRA version 10.0.