Table 4.

Treatment‐Emergent Adverse Events Reported In >1 Subject Overall by System Organ Class and MedDRA Preferred Term and Treatment; Safety Analysis Set

System Organ Class MedDRA Preferred Term	Caffeine + Placebo n= 16	Titration CBD Alone (Days 3‐11) n = 16	CBD Alone (Days 12‐25) n = 16	Caffeine + CBD (Day 26) n = 11	Total n = 16
Number of subjects (%)
Subjects experiencing any AEs	7 (43.8)	8 (50.0)	8 (50.0)	6 (54.5)	14 (87.5)
General disorders and administration‐site conditions	3 (18.8)	0	6 (37.5)	2 (18.2)	11 (68.8)
Catheter site‐related reaction	2 (12.5)	0	0	1 (9.1)	3 (18.8)
Fatigue	1 (6.3)	0	2 (12.5)	0	3 (18.8)
Pyrexia	0	0	2 (12.5)	0	2 (12.5)
Gastrointestinal disorders	1 (6.3)	6 (37.5)	5 (31.3)	2 (18.2)	9 (56.3)
Diarrhea	1 (6.3)	6 (37.5)	4 (25.0)	0	8 (50.0)
Abdominal discomfort	0	3 (18.8)	1 (6.3)	2 (18.2)	5 (31.3)
Abdominal pain	0	1 (6.3)	1 (6.3)	0	2 (12.5)
Investigations	0	0	6 (37.5)	1 (9.1)	7 (43.8)
Gamma‐glutamyltransferase increased	0	0	6 (37.5)	1 (9.1)	7 (43.8)
Alanine aminotransferase increased	0	0	5 (31.3)	1 (9.1)	6 (37.5)
Aspartate aminotransferase increased	0	0	5 (31.3)	1 (9.1)	6 (37.5)
Nervous system disorders	3 (18.8)	0	3 (18.8)	0	6 (37.5)
Headache	3 (18.8)	0	2 (12.5)	0	5 (31.3)
Musculoskeletal and connective tissue disorders	1 (6.3)	1 (6.3)	1 (6.3)	1 (9.1)	4 (25.0)
Back pain	0	1 (6.3)	1 (6.3)	0	2 (12.5)

FU, follow‐up; MedDRA, Medical Dictionary for Regulatory Activities; AE, treatment‐emergent adverse event.