Table 3 Adverse events
All adverse events a | 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 |
