Table 2.

Incidence of ADRs and Serious ADRs (n=389)

Type of ADR	All ADRs	Serious ADRs
All ADRs	105 (27.0)	43 (11.1)
ADRs by SOC
Infections and infestations	37 (9.5)	17 (4.4)
Neoplasms benign, malignant and unspecified (including cysts and polyps)	2 (0.5)	2 (0.5)
Blood and lymphatic system disorders	4 (1.0)	0
Immune system disorders	2 (0.5)	1 (0.3)
Endocrine disorders	1 (0.3)	0
Metabolism and nutrition disorders	2 (0.5)	0
Psychiatric disorders	2 (0.5)	1 (0.3)
Nervous system disorders	4 (1.0)	0
Cardiac disorders	1 (0.3)	0
Vascular disorders	1 (0.3)	0
Respiratory, thoracic and mediastinal disorders	6 (1.5)	0
Gastrointestinal disorders	27 (6.9)	19 (4.9)
Hepatobiliary disorders	3 (0.8)	1 (0.3)
Skin and subcutaneous tissue disorders	14 (3.6)	0
Musculoskeletal and connective tissue disorders	6 (1.5)	2 (0.5)
Reproductive system and breast disorders	1 (0.3)	0
General disorders and administration-site conditions	15 (3.9)	2 (0.5)
Investigations	14 (3.6)	3 (0.8)
Injury, poisoning and procedural complications	1 (0.3)	1 (0.3)
ADRs of special interest
Infection	37 (9.5)	17 (4.4)
Malignancy	2 (0.5)	2 (0.5)

Value are presented as number (%).

ADR, adverse drug reaction; SOC, system organ class.