Table 2.
All-cause adverse events observed within 30 days of DEB-TACE procedure
| AE Category | Baseline Grade 1 / 2 / 3 / 4 |
Post-Treatment Grade 1 / 2 / 3 / 4 |
|---|---|---|
| Clinical | ||
| Anorexia | 0 / 0 / 0 / 0 | 5 / 1 / 0 / 0 |
| Ascites | 7 / 3 / 4 / - | 5 / 3 / 5 / - |
| Constipation | 0 / 0 / 0 / 0 | 1 / 0 / 0 / 0 |
| Diarrhea | 0 / 0 / 0 / 0 | 2 / 0 / 0 / 0 |
| Dyspnea | 2 / 0 / 0 / 0 | 2 / 0 / 0 / 0 |
| Edema of limbs | 4 / 0 / 0 / 0 | 5 / 1 / 2 / 0 |
| Fatigue | 2 / 1 / 0 / 0 | 7 / 3 / 0 / 0 |
| Fever | 0 / 0 / 0 / 0 | 2 / 0 / 0 / 0 |
| Hepatic failure | 0 / 0 / 0 / 0 | 0 / 0 / 4 / 0 |
| Hiccups | 0 / 0 / 0 / 0 | 0 / 1 / 0 / 0 |
| Insomnia | 0 / 1 / 0 / 0 | 2 / 2 / 0 / 0 |
| Nausea | 0 / 0 / 0 / 0 | 5 / 2 / 0 / 0 |
| Pain | 0 / 0 / 0 / 0 | 4 / 2 / 2 / 0 |
| Vomiting | 0 / 0 / 0 / 0 | 0 / 0 / 0 / 0 |
| Laboratory | ||
| Hyperbilirubinemia | 2 / 6 / 4 / 0 | 2 / 5 / 7 / 0 |
| AST elevation | 10 / 2 / 0 / 0 | 10 / 3 / 3 / 0 |
| ALT elevation | 2 / 0 / 0 / 0 | 7 / 1 / 0 / 0 |
| Alkaline phosphatase elevation | 15 / 0 / 0 / 0 | 14 / 2 / 0 / 0 |
| Hypoalbuminemia | 3 / 10 / 1 / - | 1 / 12 / 1 / - |
| Hyponatremia | 8 / - / 3 / 0 | 7 / - / 7 / 1 |
| Leukopenia | 1 / 5 / 0 / 0 | 1 / 4 / 0 / 0 |
| Hemoglobin | 12 / 2 / 1 / 0 | 10 / 4 / 3 / 0 |
| Thrombocytopenia | 9 / 3 / 2 / 1 | 7 / 2 / 5 / 1 |
| Creatinine elevation | 4 / 0 / 0 / 0 | 7 / 0 / 1 / 0 |
| INR elevation | 11 / 1 / 0 / - | 11 / 3 / 0 / - |
| ECOG performance status 0 / 1 / 2 / 3 |
7 / 9 / 1 / 0 | 5 / 6 / 5 / 1 |