Table 2.
Other serious adverse events
| Category* | Adverse event | Grade 3 (n = 72) | Grade 4 (n = 10) | Grade 5 (n = 3) | Total (n = 84) |
|---|---|---|---|---|---|
| Analytical | Anaemia | 3 | 3 | ||
| Thrombocytopenia | 1 | 1 | |||
| Bleeding | Oesophagus | 4 | 1 | 4 | |
| Gastrointestinal | 1 | 2 | 1 | 4 | |
| Haemorrhage at ileostomy | 1 | 1 | |||
| Fundal variceal haemorrhage | 1 | 1 | |||
| Bleeding from gastric ulcer | 1 | 1 | |||
| Left liver lobe | 1 | 1 | |||
| Rectum | 1 | 1 | |||
| Cardio-pulmonary | Heart failure | 1 | 1 | ||
| Respiratory failure | 1 | 1 | |||
| Pleural effusion | 1 | 1 | 2 | ||
| Circulatory insufficiency | 1 | 1 | |||
| Central embolism of the pulmonal artery | 1 | 1 | |||
| Dyspnoea | 1 | 1 | |||
| Digestive | Sub-occlusion | 1 | 1 | 2 | |
| Diarrhoea | 3 | 1 | 4 | ||
| Mouth ulceration | 1 | 1 | |||
| General | Depression | 2 | 2 | ||
| Somnolence | 4 | 4 | |||
| Anorexia | 3 | 3 | |||
| Weight loss | 1 | 1 | |||
| Sleep disorder | 1 | 1 | |||
| Infectious | Cholangio-sepsis | 1 | 1 | ||
| Streptococci infection | 1 | 1 | |||
| Sepsis for staphylococcus aureus with endocarditis | 1 | 1 | |||
| Bilateral lower limb gangrene | 1 | 1 | |||
| Infection of necrotic tumour areas in liver | 1 | 1 | |||
| Infection with E. coli | 1 | 1 | |||
| Infected biloma | 1 | 1 | |||
| Spontaneous bacterial peritonitis | 1 | 1 | |||
| Liver and portal system | Cholangitis | 2 | 1 | 3 | |
| Ascites | 7 | 1 | 8 | ||
| Jaundice | 3 | 1 | 4 | ||
| Cholestasis | 1 | 1 | |||
| Intrahepatic thrombosis of the portal vein | 1 | 1 | |||
| Infarction of ventral part of the spleen | 1 | 1 | |||
| Hepatic encephalopathy | 2 | 2 | |||
| Biloma | 1 | 1 | |||
| Deterioration of the liver function | 1 | 1 | |||
| Neurological, pain, and other sensitive disorders | Hand-foot syndrome | 3 | 3 | ||
| Bone pain | 2 | 2 | |||
| Epileptic seizure | 1 | 1 | |||
| Back pain | 1 | 1 | |||
| Renal and fluid balance | Acute renal failure | 2 | 2 | ||
| Other | Wound rupture after liver surgery | 1 | 1 | ||
| Teeth destroyed | 1 | 1 | |||
| Rash of the skin due to antibiotics | 1 | 1 |
*51 patients experienced 84 severe adverse events in the “other” category