Table 2.

The incidence of AEs according to SOC and PT

SOC, PT	0.4 mg/kg (N = 6)		0.6 mg/kg (N = 6)		0.9 mg/kg (N = 6)
	Number of subjects (%)	Number of events	Number of subjects (%)	Number of events	Number of subjects (%)	Number of events
Total	5 (83.3)	13	5 (83.3)	7	5 (83.3)	21
Nervous system disorders	2 (33.3)	2	2 (33.3)	2	5 (83.3)	5
Abnormal limb movements	2 (33.3)	2	2 (33.3)	2	5 (83.3)	5
Cardiac disorders	4 (66.7)	5	2 (33.3)	2	2 (33.3)	2
Sinus bradycardia	4 (66.7)	4	2 (33.3)	2	2 (33.3)	2
Atrioventricular block	1 (16.7)	1	0 (0)	0	0 (0)	0
Investigations	1 (16.7)	4	1 (16.7)	1	4 (66.7)	7
Prolonged QT interval	1 (16.7)	4	1 (16.7)	1	3 (50.0)	6
Elevated urobilinogen	0 (0)	0	0 (0)	0	1 (16.7)	1
Gastrointestinal disorders	0 (0)	0	1 (16.7)	1	2 (33.3)	2
Thirst	0 (0)	0	0 (0)	0	1 (16.7)	1
Canker sore	0 (0)	0	1 (16.7)	1	1 (16.7)	1
General disorders and administration site conditions	1 (16.7)	1	0 (0)	0	2 (33.3)	2
Medical devices related pain	1 (16.7)	1	0 (0)	0	2 (33.3)	2
Infections and infestations	0 (0)	0	0 (0)	0	1 (16.7)	1
Influenza	0 (0)	0	0 (0)	0	1 (16.7)	1
Musculoskeletal and connective tissue disorders	1 (16.7)	1	0 (0)	0	0 (0)	0
Musculoskeletal discomfort	1 (16.7)	1	0 (0)	0	0 (0)	0
Psychiatric disorders	0 (0)	0	0 (0)	0	1 (16.7)	1
Dysphoria	0 (0)	0	0 (0)	0	1 (16.7)	1
Vascular disorders	0 (0)	0	1 (16.7)	1	0 (0)	0
Hypotension	0 (0)	0	1 (16.7)	1	0 (0)	0
Eye disorders	0 (0)	0	0 (0)	0	1 (16.7)	1
Blurred vision	0 (0)	0	0 (0)	0	1 (16.7)	1

Note: PT, preferred terms; SOC, systematic organ classification.