Table 3.
Treatment related adverse events in the two groups.
| Adverse events, n (%) | Any Grade | Grade 3 or 4 | ||||
|---|---|---|---|---|---|---|
| TACE+D group (n=157) | TACE+DP group (n=166) | P value | TACE+D group(n=157) | TACE+DP group (n=166) | P value | |
| Adverse events related to TACE | ||||||
| Fever | 85 (54.1) | 89 (53.6) | 0.478 | 0 | 0 | – |
| Pain | 74 (47.1) | 77 (46.4) | 0.470 | 3 (1.9) | 4 (2.4) | 0.422 |
| Gastrointestinal reaction | 59 (37.6) | 57 (34.3) | 0.277 | 0 | 0 | – |
| Nausea and vomiting | 49(31.2) | 51 (30.7) | 0.478 | 0 | 0 | – |
| Ascites | 18 (11.5) | 20 (12.0) | 0.464 | 5 (3.2) | 7 (4.2) | 0.348 |
| Liver abscess | 1 (0.6) | 2 (1.2) | 0.345 | 0 | 2 (1.2) | 0.129 |
| Adverse events related to donafenib and/or programmed death-1 (PD-1) inhibitor | ||||||
| Any adverse event | 146 (92.9) | 157 (94.6) | 0.270 | 53 (33.8) | 62 (37.3) | 0.253 |
| Hand-foot syndrome | 76 (48.4) | 80 (48.2) | 0.484 | 15(7.6) | 14 (8.4) | 0.393 |
| Diarrhea | 44 (28.0) | 49 (29.5) | 0.421 | 9(5.7) | 11 (6.6) | 0.410 |
| Hypertension | 42(26.7) | 50 (30.1) | 0.256 | 15(9.5) | 16(9.6) | 0.484 |
| Decreased platelet count | 40(25.5) | 48(28.9) | 0.247 | 3(1.9) | 5(3.0) | 0.293 |
| Fatigue | 37 (23.5) | 42 (25.3) | 0.395 | 0 | 0 | - |
| Abnormal liver function | 33(21.0) | 39 (23.5) | 0.319 | 4(2.5) | 6(3.6) | 0.324 |
| Alopecia | 30(19.1) | 35(21.1) | 0.360 | 0 | 0 | – |
| Rash | 29(18.4) | 34 (20.5) | 0.355 | 0 | 0 | - |
| Proteinuria | 27(17.2) | 32 (19.3) | 0.343 | 1(0.6) | 1(0.6) | 0.484 |
| Decreased appetite | 22 (14.0) | 28 (16.9) | 0.245 | 0 | 0 | - |
| Abdominal pain | 5 (3.2) | 12 (7.2) | 0.043 | 1 (0.6) | 2 (1.2) | 0.345 |
| Hyperammonemia | 4 (2.5) | 19 (11.4) | 0.001 | 0 | 1(0.6) | - |
| Hypothyroidism | 4 (0.9) | 48 (10.6) | <0.001 | 0 | 0 | - |
| Gastrointestinal hemorrhage | 49 (10.7) | 43 (9.5) | 0.102 | 4(2.5) | 3(1.8) | 0.331 |
| RCCEP | 0 | 24(14.5) | – | 0 | 1(0.6) | - |
| Immune-related pneumonia | 0 | 4(2.4) | – | 0 | 1(0.6) | - |
| Immune-related myocarditis | 0 | 3(1.8) | – | 0 | 0 | - |
TACE+D, transcatheter arterial chemoembolization (TACE) conbined withdonafenib; TACE+DP, TACE conbined with donafenib and programmed death-1 (PD-1) inhibitor; RCCEP, reactive cutaneous capillary endothelial proliferation.