Study: NCT00442507

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Death - Disease Progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Coagulation: Other, IVC Clot
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: C. difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Stenosis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: GI: Abdomenal hemorrhage NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Esophagus pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk