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Table 1 Baseline characteristics of patients

From: Thymostimulin versus placebo for palliative treatment of locally advanced or metastasised hepatocellular carcinoma: a phase III clinical trial

Baseline characteristics Placebo n = 68 Thymostimulin n = 67
Patients   
Male/female (%) 82/18 84/16
Median age (years (range)) 63 (39-76) 63 (48-79)
Median body weight (kg (range)) 80 (39-108) 79 (58-112)
Mean Karnofsky score (% (range)) 87 (60-100) 89 (60-100)
Cause of liver disease (%)   
Alcohol abuse 47 55
HBV/HCV 21 18
Other 32 27
Stage of liver disease (%)   
Liver cirrhosis 90 85
Child classification: A or no cirrhosis/B/C 63/28/9 65/32/3
Tumor stage (%)   
Okuda stage I/II/III 32/56/12 35/54/11
CLIP score 0/1/2/3/4-6 0/18/35/25/22 0/15/29/29/27
BCLC stage A/B/C/D 0/16/69/15 0/22/66/12
α-FP (%)   
< 400 ng/ml 57 57
> 400 ng/ml 43 43
Tumor characteristics (%)   
Ascites 46 37
Portal vein thrombosis 32 42
Multifocal tumor manifestation 88 91
Extrahepatic metastases 40 45
Hepato-renal laboratory parameters   
Mean urea (mg/dl [95% CI]) 4.3 [2.8-5.8] 3.7 [2.8-4.5]
Mean creatinine (mg/dl [95% CI]) 0.4 [0.3-0.6] 0.5 [0.4-0.6]
Mean sodium (mmol/l [95% CI]) 137 [136-138] 137 [136-138]
Mean albumin (g/l [95% CI]) 27 [23-31] 29 [26-32]
Previous treatment (%)
(combination possible)
  
none 68 72
Surgery 15 9
Percutaneous ethanol injection (PEI) 4 2
Transarterial chemoembolisation (TACE) 25 20
Systemic hormone- and/or chemotherapy 12 9