Table 2.
Adverse events
Adverse events | Total (n = 71) | Child–Pugh class A or B (n = 54) | Child–Pugh class C (n = 17) | p value |
---|---|---|---|---|
Any adverse events | 14 (19.7%) | 8 (14.8%) | 6 (35.3%) | 0.08 |
Death | 2 (2.8%) | 1 (1.9%) | 1 (5.9%) | 0.42 |
Serious adverse events (CTCAE grade ≥ 4) | 4 (5.6%) | 2 (3.8%) | 2 (11.8%) | 0.24 |
Adverse events leading to treatment discontinuation | 2 (2.8%) | 2 (3.8%) | 0 (0.0%) | 1.00 |
CTCAE grade | ||||
Grade 1 | 5 (7.0%) | 3 (5.7%) | 2 (11.8%) | 0.59 |
Grade 2 | 2 (2.8%) | 1 (1.9%) | 1 (5.9%) | 0.42 |
Grade 3 | 3 (4.2%) | 2 (3.8%) | 1 (5.9%) | 0.57 |
Grade 4 | 2 (2.8%) | 1 (1.9%) | 1 (5.9%) | 0.42 |
Grade 5 | 2 (2.8%) | 1 (1.9%) | 1 (5.9%) | 0.42 |
Adverse events | ||||
Nosebleed | 1 (1.4%) | 0 (0.0%) | 1 (5.9%) | 0.24 |
Dysgeusia | 1 (1.4%) | 1 (1.9%) | 0 (0.0%) | 1.00 |
Hepatic encephalopathy | 2 (2.8%) | 2 (3.8%) | 0 (0.0%) | 1.00 |
Progression of diabetes mellitus | 1 (1.4%) | 0 (0.0%) | 1 (5.9%) | 0.24 |
Esophageal varices rupture | 2 (2.8%) | 1 (1.9%) | 1 (5.9%) | 0.42 |
Acute cholecystitis | 1 (1.4%) | 1 (1.9%) | 0 (0.0%) | 1.00 |
Deterioration of ascites | 2 (2.8%) | 1 (1.9%) | 1 (5.9%) | 0.42 |
Fatigue | 1 (1.4%) | 0 (0.0%) | 1 (5.9%) | 0.24 |
Pharynx discharge | 1 (1.4%) | 1 (1.9%) | 0 (0.0%) | 1.00 |
Liver failure | 1 (1.4%) | 0 (0.0%) | 1 (5.9%) | 0.24 |
Laboratory abnormalities | ||||
Total bilirubin elevation | 1 (1.4%) | 1 (1.9%) | 0 (0.0%) | 1.00 |
Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.4.0, as presented by the National Cancer Institute Cancer Therapy Evaluation Program