Table 5.

Most commonly reported SAEs

MedDRA SOC	Patients with at least one SAE (N=941)
MedDRA preferred term	All causality	Treatment relateda		Missing causality
	n (%)	n (%)	Incidence rateb	n (%)
All SOCs	113 (12.0)	24 (2.6)	0.0108	11 (1.2)
Nervous system disorders	34 (3.6)	7 (0.7)	0.0032	3 (0.3)
Multiple sclerosis	11 (1.2)	0	N/A	1 (0.1)
Multiple sclerosis relapse	8 (0.9)	1 (0.1)	0.0005	0
Psychiatric disorders	24 (2.6)	6 (0.6)	0.0027	0
Depression	9 (1.0)	1 (0.1)	0.0005	0
Infections and infestations	22 (2.3)	0	N/A	2 (0.2)
Pneumonia	8 (0.9)	0	N/A	2 (0.2)
Injury, poisoning, and procedural complications	20 (2.1)	4 (0.4)	0.0018	3 (0.3)
Fall	18 (1.9)	4 (0.4)	0.0018	2 (0.2)
Neoplasms benign, malignant, and unspecified	14 (1.5)	2 (0.2)	0.0009	0
Gastrointestinal disorders	12 (1.3)	5 (0.5)	0.0023	0

Notes: Showing all SAEs by SOC (≥1% incidence) and preferred term (≥0.5%), and the corresponding treatment-related and missing causality rates.

^aCausality as assigned by prescriber; does not include instances where causality was not provided.

^bPer year of THC:CBD exposure, calculated by dividing the number of patients reporting the SAE by the total patient-years of THC:CBD 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: CBD, cannabidiol; MedDRA, Medical Dictionary for Regulatory Activities; N/A, not applicable; SAE, serious adverse event; SOC, system organ class; THC, Δ⁹-tetrahydrocannabinol.