Study: NCT00734305

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 43 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 43 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 43 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 43 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 43 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 43 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 20 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 16 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 12 affected / 43 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 7 affected / 43 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 5 affected / 43 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 12 affected / 43 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 11 affected / 43 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 10 affected / 43 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 8 affected / 43 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 7 affected / 43 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 7 affected / 43 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 6 affected / 43 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 10 affected / 43 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 9 affected / 43 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 5 affected / 43 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Activated Partial Thrombostatin Time Prolonged
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 21 affected / 43 at risk

Adverse event: Disease progression
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 6 affected / 43 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 7 affected / 43 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 5 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any Relationship
Frequency: 3 affected / 43 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Any Relationship
Frequency: 10 affected / 43 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Any Relationship
Frequency: 5 affected / 43 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Any Relationship
Frequency: 4 affected / 43 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Any Relationship
Frequency: 3 affected / 43 at risk