Study: NCT00061893

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grades 3-5
Frequency: 12 affected / 35 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 6 affected / 35 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Bladder spasm
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 3 affected / 35 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Cystitis noninfective
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 4 affected / 35 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 4 affected / 35 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 3 affected / 35 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grades 3-5
Frequency: 15 affected / 35 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Blood fibrinogen decreased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Forced expiratory volume decreased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 3 affected / 35 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grades 3-5
Frequency: 3 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 14 affected / 35 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 6 affected / 35 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grades 3-5
Frequency: 3 affected / 35 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grades 3-5
Frequency: 3 affected / 35 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grades 3-5
Frequency: 6 affected / 35 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 18 affected / 35 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 3 affected / 35 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 3 affected / 35 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 19 affected / 35 at risk

Adverse event: Pain of skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Perineal pain
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Pharyngeal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 16 affected / 35 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 2 affected / 35 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grades 3-5
Frequency: 4 affected / 35 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 4 affected / 35 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Notes: Grades 3-5
Frequency: 16 affected / 35 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Grades 3-5
Frequency: 1 affected / 35 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grades 1-2
Frequency: 9 affected / 35 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grades 1-2
Frequency: 3 affected / 35 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grades 1-2
Frequency: 2 affected / 35 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Grades 1-2
Frequency: 2 affected / 35 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grades 1-2
Frequency: 8 affected / 35 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grades 1-2
Frequency: 2 affected / 35 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grades 1-2
Frequency: 12 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grades 1-2
Frequency: 2 affected / 35 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grades 1-2
Frequency: 3 affected / 35 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grades 1-2
Frequency: 9 affected / 35 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grades 1-2
Frequency: 17 affected / 35 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grades 1-2
Frequency: 2 affected / 35 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Grades 1-2
Frequency: 2 affected / 35 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Grades 1-2
Frequency: 4 affected / 35 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grades 1-2
Frequency: 15 affected / 35 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Recall phenomenon
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grades 1-2
Frequency: 10 affected / 35 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Grades 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grades 1-2
Frequency: 2 affected / 35 at risk