Table 3. Adverse events.

	All adverse eventsa		Adverse drug reactions
	Any grade	Grades 3 or 4	Any grade	Grades 3 or 4
Overall incidence	12 (100)	4 (33)	12 (100)	0
Application site disorders
Injection site pain	12 (100)	0	12 (100)	0
Body as a whole-general disorders
Ascites	1 (8)	0	0	0
Fatigue	4 (33)	0	4 (33)	0
Fever	8 (67)	0	8 (67)	0
Pain	7 (58)	0	6 (50)	0
Pain neck/shoulder	1 (8)	0	0	0
Sweating increased	1 (8)	0	1 (8)	0
Weakness	1 (8)	0	0	0
Central and peripheral nervous system disorders
Headache	5 (42)	0	4 (33)	0
Gastro-intestinal system disorders
Hiccups	1 (8)	0	0	0
Nausea	1 (8)	0	0	0
Hearing and vestibular disorders
Tinnitus	1 (8)	0	0	0
Platelet bleeding and clotting disorder
Platelets count decreased	9 (75)	1 (8)	0	0
Psychiatric disorders
Insomnia	1 (8)	0	0	0
Reproductive disorders, female
Menorrhagia	0	1 (8)	0	0
Red blood cell disorders
Haematocrit decreased	5 (42)	0	0	0
Haemoglobin decreased	6 (50)	0	0	0
RBC decreased	5 (42)	0	0	0
Respiratory system disorders
Rhinitis	1 (8)	0	0	0
Rhinorrhea	2 (17)	0	0	0
Secondary terms – events
Brain metastases	0	1 (8)	0	0
Hepatoma recurrence	0	2 (17)	0	0
Lymph node metastases	0	1 (8)	0	0
Musculoskeletal system disorders
Myalgia	3 (25)	0	3 (25)	0
White cell and RES disorders
Eosinophil count decreased	3 (25)	0	0	0
Eosinophil count increased	5 (42)	0	0	0
Leukopenia	8 (67)	1 (8)b	0	0
Lymphocytosis	3 (25)	0	0	0
Lymphopenia	1 (8)	1 (8)b	0	0
Monocytosis	9 (75)	0	0	0
Neutropenia	7 (58)	1 (8)b	0	0
Neutrophil count increased	2 (17)	0	0	0
White blood cell count increased	1 (8)	0	0	0

^aListed are adverse events, as defined by the World Health Organization-Adversary Reaction Terminology (WHO-ART) version 092. Data are expressed as n (%). NA denotes not applicable.

^bThe adverse events regarding white blood cells occurred simultaneously in one patient.