Study: NCT00542971

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 78 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 78 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 78 at risk

Adverse event: Elevated Alanine Aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 78 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Notes: All events were unrelated to study drug.
Frequency: 3 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 75 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 75 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 75 at risk

Adverse event: Rash Hand Foot Reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 75 at risk

Adverse event: Cardiac General
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Elevated Alanine Aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 75 at risk

Adverse event: Opportunistic infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 75 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 75 at risk

Adverse event: Rash Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 75 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 75 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 75 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hemorrhage Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 75 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 75 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 75 at risk

Adverse event: Mood Alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 75 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 75 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 75 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 75 at risk

Adverse event: Aphasia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cardiac Ischemia/Infarct
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk