Study: NCT01298648

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Abscess intestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Cholangitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1693 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1693 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1693 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1693 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Vestibular neuronitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1693 at risk

Adverse event: Salpingo-oophoritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Intestinal fistula infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Pneumonia pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1693 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Chlamydial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Enterocolitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Herpes ophthalmic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1693 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1693 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1693 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1693 at risk

Adverse event: Schwannoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1693 at risk

Adverse event: Anal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1693 at risk

Adverse event: Leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1693 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1693 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Hyperamylasaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Panic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Adjustment disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Cranial nerve palsies multiple
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Mononeuropathy multiplex
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Central nervous system vasculitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Chronic inflammatory demyelinating polyradiculoneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Jugular vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Vena cava thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Pulmonary artery thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Anal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Anorectal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 1693 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Frequent bowel movements
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Gastrointestinal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: IIleal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1693 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1693 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Intestinal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1693 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1693 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Rectal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Small intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1693 at risk

Adverse event: Enterocutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Anorectal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1693 at risk

Adverse event: Rash erythematous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Renal haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1693 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1693 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1693 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1693 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1693 at risk

Adverse event: Red blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1693 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1693 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1693 at risk

Adverse event: Administration related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1693 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 1693 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1693 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 1693 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 1693 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 1693 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 1693 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 1693 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1693 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 1693 at risk

Adverse event: Liver disorder
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 1693 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 1693 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 1693 at risk

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Frequency: 24 affected / 1693 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 9 affected / 1693 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 1693 at risk