Study: NCT00363883

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Urinary tract procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 14 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 14 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 14 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 14 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Disease progression
Serious: no
Organ System: General disorders
Frequency: 6 affected / 14 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 14 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 14 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 14 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 14 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 14 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 14 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 14 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 14 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 14 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 14 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 14 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 14 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 14 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 14 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 14 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 14 at risk

Adverse event: Blood magnesium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 14 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 14 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 14 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 14 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 14 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 14 at risk

Adverse event: Haemorrhage urinary tract
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk