Table 2.
AEs after LP-irinotecan-TACE treatment sessions graded according to CTCAE 4.3/5.0. Data is presented as counts and percentages.
| Adverse Events at the Same Day as a Treatment Session | ||||
| Total AEs | 269 | |||
| Patients with at least 1 AE, n (%) | 91 (60) | |||
| Total grade 3 or 4 | 19 | |||
| Patients with at least 1 grade 3 or 4 AE, n (%) | 12 (8) | |||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Infusion related reaction | 0 | 0 | 1 | 0 |
| Post-embolization syndrome | 0 | 0 | 0 | 0 |
| Pain | 87 | 34 | 4 | 0 |
| Nausea/vomiting | 66 | 18 | 8 | 0 |
| Fever | 9 | 1 | 0 | 0 |
| Hypertension | 0 | 1 | 1 | 0 |
| Diarrhea | 0 | 1 | 0 | 0 |
| Hemorrhage (liver subcapsular hematoma) | 1 | 0 | 0 | 0 |
| Hypertonia | 0 | 0 | 3 | 0 |
| Platelet count decreased | 2 | 0 | 0 | 0 |
| Other | 3 1 | 6 2 | 2 3 | 0 |
| Adverse events within 30 days after any treatment session | ||||
| Total AEs | 115 | |||
| Patients with at least 1 AE, n (%) | 49 (32) | |||
| Total grade 3 or 4 | 33 | |||
| Patients with at least 1 grade 3 or 4 AE, n (%) | 21 (14) | |||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Pain | 15 | 18 | 4 | 0 |
| Fever | 8 | 2 | 0 | 1 |
| Nausea/vomiting | 6 | 10 | 5 | 0 |
| Diarrhoea | 2 | 2 | 0 | 0 |
| Alopecia | 0 | 0 | 1 | 0 |
| Hepatic failure | 0 | 0 | 1 | 0 |
| Cholecystitis | 0 | 1 | 1 | 0 |
| Vertigo | 2 | 0 | 0 | 0 |
| Asthenia/Fatigue | 0 | 2 | 0 | 0 |
| Neutropenia | 1 | 0 | 0 | 2 |
| Increase in serum creatinine | 1 | 0 | 0 | 0 |
| Increase in alkaline phosphatase | 28 | 4 | 0 | 0 |
| Increase in ALT | 21 | 3 | 2 | 0 |
| Increase in AST | 19 | 3 | 0 | 0 |
| Blood bilirubin increase | 6 | 0 | 2 | 1 |
| Thrombocytopenia | 2 | 0 | 0 | 0 |
| Lymphocyte count decreased | 23 | 4 | 0 | 0 |
| Hypoalbuminemia | 22 | 6 | 1 | 0 |
| LDH | 8 | 0 | 0 | 0 |
| Other | 4 4 | 5 5 | 6 6 | 4 7 |
1 Sinus bradycardia, vertigo, nontarget embolization of falciform artery with skin rash. 2 Anorexia, discomfort, fatigue, GOT GPT increased, lower limb edema, dislocation of one coil during coiling of Art. Cystica. 3 Abscess, cholecystitis. 4 Bradycardia, flatulence, obstipation, nontarget embolization of falciform artery with skin rash. 5 Hematoma groin, Lower limb oedema, Ascites, Anorexia, Abdominal Abscess. 6 Hepatic infection, osteolysis, infection, CRP increasing, renal failure + hyperkalemia, abscess. 7 Sepsis, colonic obstruction, stomach perforation.