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Table 2 Comparison between groups of (serious) adverse events (AE) graded according to ECOG criteria and occurring in more than 2% of all patients (n = 135; significance level p < 0.05)

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

ECOG toxicity criteria Placebo (n = 68) Thymostimulin (n = 67) p-value
  Grade 1 Grade 2 Grade 3 Grade 4 Grade 1 Grade 2 Grade 3 Grade 4 single tests
Haematology          
Anaemia   1   1 2     0.9880
Constitutional symptoms          
Fatigue   2 2 1   1 1   0.2525
Dermatology          
Injection site reaction   1    1 3    0.1663
Pain          
Abdominal pain 1    2 1    2 0.9852
Arthralgia    1   3     0.3029
Infection          
Infection without neutropenia 3   4 1 1 3 3   0.8077
Gastrointestinal/Hepatic          
Diarrhoea 1   2   2 2    0.6831
Hyperbilirubinaemia     2     1 0.5681
Elevated transaminases   1 2 1 2 1 2   0.7128
GI haemorrhage    4 2    4 6 0.2728
Ascites (without renal failure)   1 14 3   2 6   0.0323
Renal          
Elevated creatinine or urea 5 2    1    1 0.0887
Renal failure (with ascites)    7 5     2 0.0052
Pulmonary          
Dyspnoea   3 4    1    0.0303
Pleural effusion    6     1   0.0548
Neurology          
Encephalopathy     6     5 0.7726