TABLE 3.

Number (%) of patients having adverse events (AEs) by system organ class.

System organ class	Total AEs	Severe AEs	Drug‐related AEs
Nervous system disorders	174 (12.9)	0 (0.0)	62 (4.6)
Vascular disorders	117 (8.7)	6 (0.4)	35 (2.6)
General disorders and administration site conditions	73 (5.4)	1 (0.1)	31 (2.3)
Cardiac disorders	61 (4.5)	3 (0.2)	20 (1.4)
Gastrointestinal disorders	59 (4.3)	1 (0.1)	14 (1.0)
Respiratory, thoracic and mediastinal disorders	41 (3.0)	3 (0.2)	6 (0.4)
Psychiatric disorders	37 (2.7)	0 (0.0)	23 (1.7)
Investigations	20 (1.4)	0 (0.0)	2 (0.1)
Metabolism and nutrition disorders	19 (1.4)	0 (0.0)	1 (0.1)
Skin and subcutaneous tissue disorders	18 (1.3)	0 (0.0)	7 (0.5)
Renal and urinary disorders	15 (1.1)	2 (0.1)	1 (0.1)
Musculoskeletal and connective tissue disorders	13 (0.9)	0 (0.0)	1 (0.1)
Eye disorders	11 (0.8)	0 (0.0)	3 (0.2)
Hepatobiliary disorders	6 (0.4)	0 (0.0)	0 (0.0)
Reproductive system and breast disorders	6 (0.4)	1 (0.1)	0 (0.0)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	3 (0.2)	1 (0.1)	0 (0.0)
Endocrine disorders	3 (0.2)	0 (0.0)	0 (0.0)
Ear and labyrinth disorders	2 (0.1)	0 (0.0)	0 (0.0)
Surgical and medical procedures	1 (0.1)	0 (0.0)	0 (0.0)
Immune system disorders	1 (0.1)	0 (0.0)	1 (0.1)
Blood and lymphatic system disorders	1 (0.1)	0 (0.0)	0 (0.0)