All-grade treatment-emergent AEs within 4 weeks after first TACE with frequency≥10% in either group and corresponding Grades 3 and 4 AEs
n (%) | TACE plus sorafenib (n=77) | TACE alone (n=71) | ||||||
All grade | Grades 1–2 | Grade 3 | Grade 4 | All grade | Grades 1–2 | Grade 3 | Grade 4 | |
Elevated AST | 72 (93.5) | 50 (64.9) | 17 (22.1) | 5 (6.5) | 65 (91.5) | 50 (70.4) | 14 (19.7) | 1 (1.4) |
Elevated ALT | 69 (89.6) | 50 (64.9) | 18 (23.4) | 1 (1.3) | 55 (77.5) | 42 (59.2) | 13 (18.3) | 0 (0.0) |
Thrombocytopaenia | 67 (87.0) | 57 (74.0) | 10 (13.0) | 0 (0.0) | 53 (74.6) | 51 (71.8) | 2 (2.8) | 0 (0.0) |
Elevated bilirubin | 55 (71.4) | 54 (70.1) | 1 (1.3) | 0 (0.0) | 39 (54.9) | 37 (52.1) | 2 (2.8) | 0 (0.0) |
Anaemia | 50 (64.9) | 49 (63.6) | 1 (1.3) | 0 (0.0) | 35 (49.3) | 34 (47.9) | 1 (1.4) | 0 (0.0) |
Hand-foot skin reaction | 41 (53.2) | 37 (48.1) | 4 (5.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hypertension | 40 (51.9) | 32 (41.6) | 8 (10.4) | 0 (0.0) | 28 (39.4) | 25 (35.2) | 3 (4.2) | 0 (0.0) |
Elevated lipase | 38 (49.4) | 26 (33.8) | 11 (14.3) | 1 (1.3) | 18 (25.4) | 16 (22.5) | 2 (2.8) | 0 (0.0) |
Elevated serum amylase | 32 (41.6) | 26 (33.8) | 6 (7.8) | 0 (0.0) | 19 (26.8) | 18 (25.4) | 1 (1.4) | 0 (0.0) |
Neutropaenia | 29 (37.7) | 25 (32.5) | 4 (5.2) | 0 (0.0) | 29 (40.8) | 29 (40.8) | 0 (0.0) | 0 (0.0) |
Decreased WBC count | 29 (37.7) | 28 (36.4) | 1 (1.3) | 0 (0.0) | 26 (36.6) | 26 (36.6) | 0 (0.0) | 0 (0.0) |
Malaise | 20 (26.0) | 20 (26.0) | 0 (0.0) | 0 (0.0) | 9 (12.7) | 9 (12.7) | 0 (0.0) | 0 (0.0) |
Fatigue | 19 (24.7) | 17 (22.1) | 2 (2.6) | 0 (0.0) | 7 (9.9) | 7 (9.9) | 0 (0.0) | 0 (0.0) |
Fever | 15 (19.5) | 14 (18.2) | 1 (1.3) | 0 (0.0) | 18 (25.4) | 18 (25.4) | 0 (0.0) | 0 (0.0) |
Anorexia | 11 (14.3) | 9 (11.7) | 2 (2.6) | 0 (0.0) | 8 (11.3) | 7 (9.9) | 1 (1.4) | 0 (0.0) |
Diarrhoea | 11 (14.3) | 9 (11.7) | 2 (2.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Erythema multiforme | 9 (11.7) | 7 (9.1) | 2 (2.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Weight loss | 9 (11.7) | 9 (11.7) | 0 (0.0) | 0 (0.0) | 2 (2.8) | 2 (2.8) | 0 (0.0) | 0 (0.0) |
Hoarseness | 9 (11.7) | 9 (11.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
AEs, adverse events; ALT, alanine aminotransaminase; AST, aspartate aminotransferase; TACE, transarterial chemoembolisation; WBC, white blood cell.