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)
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 | ||||||