Study: NCT00511862

Adverse event: Abdominal or epigastric pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 151 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: Decreased platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Esophagial varices
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: GI ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 151 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Thrombosis/embolus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Vessel injury - lower extremity artery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 151 at risk

Adverse event: ALT > ULN
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 151 at risk

Adverse event: AST >ULN
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 151 at risk

Adverse event: Alkaline phosphatase >ULN
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 56 affected / 151 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 151 at risk

Adverse event: Bilirubin >ULN
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 151 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 151 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 91 affected / 151 at risk

Adverse event: Hypoalbuminemia < LLN
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 151 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 151 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 151 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 151 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 11 affected / 151 at risk