Study: NCT01983683

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 294 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 294 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Bronchitis fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 294 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 294 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 294 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 294 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 294 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Haematoma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 294 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 294 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 294 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 294 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Porphyria acute
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 294 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 294 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 294 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 294 at risk

Adverse event: Transplant abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Urinary tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Clostridium difficile infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 294 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 294 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 294 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 294 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 307 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 307 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 307 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 307 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 307 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 307 at risk

Adverse event: Contrast media reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 307 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Enterobacter sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Enterocolitis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Escherichia test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 307 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Herpes simplex hepatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 307 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 307 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 307 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 307 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 307 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Pneumonia klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Pseudomembranous colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 307 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 307 at risk

Adverse event: Renal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 307 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 307 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 307 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Clostridium difficile infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 307 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 307 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 307 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 307 at risk