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Daniele et al. Hepatoma Res 2021;7:61 https://dx.doi.org/10.20517/2394-5079.2021.58 Page 9 of 14

Table 2. Any grade and severe toxicity according to CTCAE categories and subcategories, by treatment arm
Any grade (> 0) Severe (≥ 3)
Toxicity BSC (n = 15) BSC + Sorafenib (n = 17) BSC (n = 15) BSC + Sorafenib (n = 17)
†
†
†
†
Any type 6 (40.0%) 15 (88.2%) 2 (13.3%) 9 (52.9%)
Blood
Anemia 1 (6.7%) 3 (17.6%) 0 (0.0%) 2 (11.8%)
Cardiac
Atrial fibrillation 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Gastrointestinal
Abdominal distension 0 (0.0%) 2 (11.8%) 0 (0.0%) 0 (0.0%)
Abdominal pain 0 (0.0%) 4 (23.5%) 0 (0.0%) 1 (5.9%)
Ascites 3 (20.0%) 5 (29.4%) 1 (6.7%) 1 (5.9%)
Constipation 1 (6.7%) 1 (5.9%) 1 (6.7%) 0 (0.0%)
Diarrhea 1 (6.7%) 4 (23.5%) 0 (0.0%) 1 (5.9%)
Dry mouth 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Mucositis (oral) 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Nausea 1 (6.7%) 4 (23.5%) 0 (0.0%) 1 (5.9%)
General disorders
Fatigue 3 (20.0%) 6 (35.3%) 0 (0.0%) 2 (11.8%)
Fever 1 (6.7%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Other 1 (6.7%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Pain 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Investigation
Amylase increased 0 (0.0%) 1 (5.9%) 0 (0.0%) 1 (5.9%)
ALP increase 1 (6.7%) 4 (23.5%) 0 (0.0%) 0 (0.0%)
ALT increase 1 (6.7%) 4 (23.5%) 0 (0.0%) 3 (17.6%)
AST increase 1 (6.7%) 4 (23.5%) 0 (0.0%) 1 (5.9%)
Bilirubin increased 2 (13.3%) 7 (41.2%) 0 (0.0%) 1 (5.9%)
GGT increased 0 (0.0%) 2 (11.8%) 0 (0.0%) 0 (0.0%)
Haptoglobin decreased 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Weight gain 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Metabolism
Anorexia 1 (6.7%) 5 (29.4%) 0 (0.0%) 0 (0.0%)
Dehydration 2 (13.3%) 1 (5.9%) 0 (0.0%) 1 (5.9%)
Nervous system
Encephalopathy 1 (6.7%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Psychiatric
Agitation 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Depression 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Restlessness 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Skin
Erythema 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
‡
PPE 0 (0.0%) 3 (17.6%) 0 (0.0%) 0 (0.0%)
Pruritus 1 (6.7%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
Rash maculo papular 0 (0.0%) 2 (11.8%) 0 (0.0%) 0 (0.0%)
Vascualar
Hypertension 0 (0.0%) 4 (23.5%) 0 (0.0%) 0 (0.0%)
Hypotension 0 (0.0%) 1 (5.9%) 0 (0.0%) 0 (0.0%)
† ‡
BSC: Best supportive care; PPE: palmar-plantar erythrodysesthesia syndrome.