Study: NCT00491244

Adverse event: Intractable diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 189 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 189 at risk

Adverse event: Postural dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 189 at risk

Adverse event: Stevens-Johnson sybdrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 189 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 47 affected / 189 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 106 affected / 189 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 189 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 189 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 189 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 189 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 189 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 189 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 189 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 189 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 189 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 189 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 189 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hemoglobin level \< 8.5 g/dL
Frequency: 134 affected / 189 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Absolute neutrophil count \< 750 x 10\^9 cells/L
Frequency: 30 affected / 189 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelet count \< 50 x 10\^9 cells/L
Frequency: 19 affected / 189 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 188 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 188 at risk

Adverse event: Peptic ulcer bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 188 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 188 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 188 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 50 affected / 188 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 188 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 188 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 66 affected / 188 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 188 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 188 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 188 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 188 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 188 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 188 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 188 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 188 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 188 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hemoglobin level \< 8.5 g/dL
Frequency: 13 affected / 188 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Absolute neutrophil count \< 750 x 10\^9 cells/L
Frequency: 26 affected / 188 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelet count \< 50 x 10\^9 cells/L
Frequency: 21 affected / 188 at risk