Study: NCT00930644

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Crohns disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Faecal volume increased
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: Face oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Injection site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Soft tissue inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Device related bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Catheter site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Hepatic cyst infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Gastrointestinal stoma complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 51 at risk

Adverse event: Device breakage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: Gamma glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Delusional disorder, unspecified type
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hydrothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Jugular vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Blood and Lymphatic System Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes abdominal pain, nausea, abdominal distension, diarrhea, flatulence, vomiting, abdominal pain upper, dyspepsia, abdominal discomfort, constipation, faecal volume increased, intestinal obstruction, abdominal pain lower, and others.
Frequency: 34 affected / 51 at risk

Adverse event: General Disorders, and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 27 affected / 51 at risk

Adverse event: Hepatobiliary Disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 51 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 51 at risk

Adverse event: Injury, Poisoning, and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 51 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 22 affected / 51 at risk

Adverse event: Metabolism and Nutrition Disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 51 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 51 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 51 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 51 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 51 at risk

Adverse event: Respiratory, Thoracic, and Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 51 at risk

Adverse event: Angiopathy
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 51 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Crohns disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Papilla of Vater stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 37 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 37 at risk

Adverse event: Catheter site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Brain abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Chemical burn of the eye
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Intestinal anastomosis complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 37 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Superior vena caval stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Blood and Lymphatic System Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 37 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes abdominal pain, nausea, abdominal distension, diarrhea, flatulence, vomiting, abdominal pain upper, dyspepsia, abdominal discomfort, constipation, faecal volume increased, intestinal obstruction, abdominal pain lower, and others.
Frequency: 20 affected / 37 at risk

Adverse event: General Disorders, and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 15 affected / 37 at risk

Adverse event: Hepatobiliary Disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 37 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 37 at risk

Adverse event: Injury, Poisoning, and Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 37 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 19 affected / 37 at risk

Adverse event: Metabolism and Nutrition Disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 37 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 37 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 37 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 37 at risk

Adverse event: Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 37 at risk

Adverse event: Respiratory, Thoracic, and Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 37 at risk

Adverse event: Angiopathy
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 37 at risk