Study: NCT00956930

Adverse event: Abdominal pain
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3 or 4 Abdominal Pain according to CTCAE V4.0
Frequency: 1 affected / 24 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3 or 4 hypoalbuminemia according to CTCAE (4.0)
Frequency: 1 affected / 24 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3 or 4 bilirubin toxicity according to CTCAE (4.0)
Frequency: 2 affected / 24 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or 4 decrease in leukocyte count according to CTCAE (4.0)
Frequency: 1 affected / 24 at risk

Adverse event: Liver Decompensation
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hepatic function deterioration due to treatment or decompensation due to preexisting hepatic cirrhosis
Frequency: 3 affected / 24 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Notes: Development of severe generalized infection (sepsis).
Frequency: 2 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2 fatigue according to CTCAE (4.0)
Frequency: 21 affected / 24 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 abdominal pain according to CTCAE (4.0)
Frequency: 6 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2 nausea according to CTCAE (4.0)
Frequency: 7 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2 vomiting according to CTCAE (4.0)
Frequency: 1 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2 fever according to CTCAE (4.0)
Frequency: 1 affected / 24 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2 anorexia according to CTCAE (4.0)
Frequency: 6 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2 Constipation according to CTCAE (4.0)
Frequency: 1 affected / 24 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 hypoalbuminemia according to CTCAE (4.0)
Frequency: 1 affected / 24 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 hyperbilirubinemia according to CTCAE (4.0)
Frequency: 6 affected / 24 at risk

Adverse event: Alkaline Phosphatase toxicity
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 alkaline Phosphatase toxicity according to CTCAE (4.0)
Frequency: 6 affected / 24 at risk

Adverse event: Alanine aminotransferase toxicity
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 alanine aminotransferase toxicity according to CTCAE (4.0)
Frequency: 3 affected / 24 at risk

Adverse event: Aspartate aminotransferase toxicity
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 aspartate aminotransferase toxicity according to CTCAE (4.0)
Frequency: 5 affected / 24 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 or 2 leukopenia according to CTCAE (4.0)
Frequency: 1 affected / 24 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3 or 4 bilirubin toxicity according to CTCAE (4.0)
Frequency: 1 affected / 19 at risk

Adverse event: Aspartate aminotransferase toxicity
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3 or 4 aspartate aminotransferase toxicity according to CTCAE (4.0)
Frequency: 2 affected / 19 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or 4 neutropenia according to CTCAE (4.0)
Frequency: 2 affected / 19 at risk

Adverse event: Liver Decompensation
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hepatic function deterioration due to treatment or decompensation due to preexisting hepatic cirrhosis
Frequency: 1 affected / 19 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Infection of cutaneous and subcutaneous tissue
Frequency: 1 affected / 19 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3 or higher hypokalemia
Frequency: 1 affected / 19 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Notes: Development of severe generalized infection (sepsis).
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2 fatigue according to CTCAE (4.0)
Frequency: 12 affected / 19 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 abdominal pain according to CTCAE (4.0)
Frequency: 10 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2 nausea according to CTCAE (4.0)
Frequency: 8 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2 vomiting according to CTCAE (4.0)
Frequency: 3 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1 or 2 fever according to CTCAE (4.0)
Frequency: 3 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2 anorexia according to CTCAE (4.0)
Frequency: 4 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 or 2 diarrhea according to CTCAE (4.0)
Frequency: 4 affected / 19 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 hypoalbuminemia according to CTCAE (4.0)
Frequency: 11 affected / 19 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 hyperbilirubinemia according to CTCAE (4.0)
Frequency: 5 affected / 19 at risk

Adverse event: Alkaline Phosphatase toxicity
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 alkaline Phosphatase toxicity according to CTCAE (4.0)
Frequency: 2 affected / 19 at risk

Adverse event: Alanine aminotransferase toxicity
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 alanine aminotransferase toxicity according to CTCAE (4.0)
Frequency: 4 affected / 19 at risk

Adverse event: Aspartate aminotransferase toxicity
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 1 or 2 aspartate aminotransferase toxicity according to CTCAE (4.0)
Frequency: 7 affected / 19 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 or 2 leukopenia according to CTCAE (4.0)
Frequency: 2 affected / 19 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 or 2 neutropenia according to CTCAE (4.0)
Frequency: 1 affected / 19 at risk