Table 4.
Adverse events of any causes that occurred in ≥10% of participants in the safety population.
| ISP-TACE group (n=49) | Sora-TACE group (n=50) | ||||||
|---|---|---|---|---|---|---|---|
| Adverse event | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | P |
| Higher levels of AST | 41 (84) | 2 (4) | 0 | 44 (88) | 2 (4) | 1 (2) | 0.28 |
| Higher levels of ALT | 38 (78) | 2 (4) | 0 | 42 (84) | 2 (4) | 0 | 0.38 |
| Hyperbilirubinemia | 13 (27) | 0 | 0 | 15 (30) | 1 (2) | 0 | 0.55 |
| Anemia | 34 (70) | 3 (6) | 0 | 33 (66) | 2 (4) | 0 | 0.54 |
| Thrombocytopenia | 32 (65) | 2 (4) | 0 | 34 (68) | 2 (4) | 0 | 0.78 |
| Neutropenia | 9 (18) | 0 | 0 | 7 (14) | 0 | 0 | 0.56 |
| Leukopenia | 15 (31) | 0 | 0 | 19 (38) | 1 (2) | 0 | 0.33 |
| Fatigue | 5 (10) | 0 | 0 | 12 (24) | 0 | 0 | 0.07 |
| Abdominal pain | 14 (29) | 4 (8) | 1 (2) | 6 (12) | 1 (2) | 0 | 0.01 |
| Diarrhea | 1 (2) | 0 | 0 | 5 (10) | 0 | 0 | 0.09 |
| Nausea/vomiting | 18 (37) | 1 (2) | 0 | 21 (42) | 1 (2) | 0 | 0.82 |
| Rash | 2 (4) | 0 | 0 | 7 (14) | 0 | 0 | 0.08 |
| Hand–foot skin reaction | 0 | 0 | 0 | 23 (46) | 3 (6) | 0 | / |
| Pruritus | 2 (4) | 0 | 0 | 18 (36) | 1 (2) | 0 | 0.01 |
| Alopecia | 1 (1) | 0 | 0 | 12 (24) | 0 | 0 | 0.01 |
| Constipation | 3 (6) | 0 | 0 | 5 (10) | 0 | 0 | 0.48 |
| Hypertension | 2 (4) | 0 | 0 | 6 (12) | 1 (2) | 0 | 0.08 |
| Fever | 21 (43) | 0 | 0 | 20 (40) | 0 | 0 | 0.77 |
| Malaise | 6 (12) | 0 | 0 | 11 (22) | 0 | 0 | 0.20 |
| Anorexia | 5 (10) | 0 | 0 | 7 (14) | 0 | 0 | 0.57 |
| Weight loss | 2 (4) | 0 | 0 | 5 (10) | 0 | 0 | 0.25 |
| Hoarseness | 0 | 0 | 0 | 5 (10) | 0 | 0 | / |
| Hemorrhage | 5 (10) | 1 (2) | 0 | 3 (6) | 0 | 0 | 0.28 |
Data are noted in n (%). Adverse events are presented according to the Medical Dictionary for Regulatory Affairs system organ class.
ALT, alanine aminotransaminase; AST, aspartate aminotransferase; ISP-TACE, irradiation stent placement plus transcatheter arterial chemoembolization; Sora-TACE, sorafenib plus transcatheter arterial chemoembolization.