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Table 2 Treatment related adverse events classified according to CTC-AEv3.0 Frequencies and 95% (two-sided) confidence intervals according to Pearson-Clopper

From: Impact of neo-adjuvant Sorafenib treatment on liver transplantation in HCC patients - a prospective, randomized, double-blind, phase III trial

  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 -    -