Table 3.
Most commonly reported AEs
| MedDRA SOC | Patients with at least one AE (N=941)
|
||
|---|---|---|---|
| MedDRA preferred term | All causality
|
Treatment relateda
|
|
| n (%) | n (%) | Incidence rateb | |
| All SOCs | 295 (31.3) | 123 (13.1) | 0.0556 |
| Nervous system disorders | 117 (12.4) | 55 (5.8) | 0.0248 |
| Dizziness | 29 (3.1) | 22 (2.3) | 0.0099 |
| Multiple sclerosis | 17 (1.8) | 1 (0.1) | 0.0005 |
| Multiple sclerosis relapse | 15 (1.6) | 1 (0.1) | 0.0005 |
| Somnolence | 10 (1.1) | 8 (0.9) | 0.0036 |
| Dysgeusia | 9 (1.0) | 9 (1.0) | 0.0041 |
| Psychiatric disorders | 68 (7.2) | 27 (2.9) | 0.0122 |
| Depression | 27 (2.9) | 3 (0.3) | 0.0014 |
| Anxiety | 9 (1.0) | 5 (0.5) | 0.0023 |
| Depressed mood | 10 (1.1) | 5 (0.5) | 0.0023 |
| Gastrointestinal disorders | 57 (6.1) | 32 (3.4) | 0.0144 |
| Nausea | 15 (1.6) | 10 (1.1) | 0.0045 |
| Injury, poisoning, and procedural complications | 56 (6.0) | 6 (0.6) | 0.0027 |
| Fall | 51 (5.4) | 6 (0.6) | 0.0027 |
| General disorders and administration site conditions | 50 (5.3) | 26 (2.8) | 0.0117 |
| Fatigue | 20 (2.1) | 16 (1.7) | 0.0072 |
| Infections and infestations | 37 (3.9) | 1 (0.1) | 0.0005 |
| Urinary tract infection | 12 (1.3) | 1 (0.1) | 0.0005 |
Notes: Showing all (all-causalities) AEs with ≥1% incidence by SOC and preferred term, and the corresponding treatment-related rates.
a
Causality as assigned by prescriber; does not include instances where causality was not provided.
b
Per year of THC:CBD exposure, calculated by dividing the number of patients reporting the AE by the total patient-years of THC:CDB exposure in the Registry (2,213.98 years). The bold entries denote the SOC, the nonbold text beneath each are preferred terms within that SOC.
Abbreviations: AE, adverse event; CBD, cannabidiol; MedDRA, Medical Dictionary for Regulatory Activities; SOC, system organ class; THC, Δ9-tetrahydrocannabinol.