Table III.

AEs by system organ class.

System organ class	Any AE, n (%)	Severe AE, n (%)	Drug-associated AE, n (%)
Nervous system disorder	62 (13.4)	0 (0.0)	21 (4.5)
Vascular disorder	45 (9.7)	3 (0.6)	13 (2.8)
General disorder and administration site conditions	30 (6.5)	1 (0.2)	12 (2.6)
Cardiac disorder	21 (4.5)	2 (0.4)	9 (1.9)
Gastrointestinal disorder	18 (3.9)	0 (0.0)	6 (1.3)
Respiratory, thoracic and mediastinal disorder	15 (3.2)	2 (0.4)	1 (0.2)
Metabolism and nutrition disorder	12 (2.6)	0 (0.0)	0 (0.0)
Psychiatric disorder	8 (1.7)	0 (0.0)	6 (1.3)
Skin and subcutaneous tissue disorder	7 (1.5)	0 (0.0)	2 (0.4)
Musculoskeletal and connective tissue disorder	7 (1.5)	0 (0.0)	0 (0.0)
Investigations	4 (0.9)	0 (0.0)	0 (0.0)
Eye disorder	3 (0.6)	0 (0.0)	1 (0.2)
Reproductive system and breast disorder	3 (0.6)	1 (0.2)	0 (0.0)
Renal and urinary disorder	3 (0.6)	0 (0.0)	0 (0.0)
Endocrine disorder	2 (0.4)	0 (0.0)	0 (0.0)
Immune system disorder	1 (0.2)	0 (0.0)	1 (0.2)
Hepatobiliary disorder	1 (0.2)	0 (0.0)	0 (0.0)

AE, adverse event.