Table 2 Treatment related adverse events classified according to CTC-AEv3.0 Frequencies and 95% (two-sided) confidence intervals according to Pearson-Clopper
TACE + Sorafenib | TACE + Placebo | |||||
|---|---|---|---|---|---|---|
N = 24 | N = 25 | |||||
n | % | 95% CI | n | % | 95% CI | |
Patients with at least one AE | 22 | 91.7 | 73.0 - 99.0 | 21 | 84.0 | 63.9 - 95.5 |
Blood/lymphatic disorders | ||||||
ucopenia | 10 | 41.7 | 22.1 - 63.4 | 3 | 12.0 | 2.5 - 31.2 |
thrombocytopenia | 13 | 54.2 | 32.8 - 74.4 | 14 | 56.0 | 34.9 - 75.6 |
Gastrointestinal disorders | ||||||
diarrhoea | 9 | 37.5 | 18.8 - 59.4 | 3 | 12.0 | 2.5 - 31.2 |
nausea | 3 | 12.5 | 2.7 - 32.4 | 2 | 8.0 | 1.0 - 26.0 |
General disorders | ||||||
fatigue | 5 | 20.8 | 7.1 - 42.2 | 5 | 20.8 | 6.8 - 40.7 |
weight loss | 1 | 4.2 | 0.1 - 21.1 | - | ||
Hepatobiliary disorders | ||||||
hyperbilirubinaemia | 3 | 12.5 | 2.7 - 32.4 | 3 | 12.0 | 2.5 - 31.2 |
cholangitis | 1 | 4.2 | 0.1 - 21.1 | - | ||
Dermatologic disorders | ||||||
hand-foot-syndrome | 7 | 29.2 | 12.6 - 51.1 | 1 | 4.0 | 0.1 - 20.4 |
alopecia | 1 | 4.2 | 0.1 - 21.1 | - | ||
Sever AE | 12 | 50.0 | 29.1 - 70.9 | 4 | 16.0 | 4.5 - 36.1 |
SAE (CTC-AEv3.0 GRADE 3/4) | 3 | 12.5 | 2.7 - 32.4 | 3 | 12.5 | 2.5 - 31.2 |
Study Drug discontinued due to AE | 6 | 25.0 | 9.8 - 46.7 | 1 | 4.0 | 0.1 - 20.4 |
Dose reduced due to AE | 6 | 25.0 | 9.8 - 46.7 | 2 | 8.0 | 1.0 - 26.0 |
AE resulting in death | - | - | ||||