Study: NCT00751998

Adverse event: Device dislocation
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 297 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 297 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 297 at risk

Adverse event: Heparin induced Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 297 at risk

Adverse event: Ureteral Obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: from ovarian cancer
Frequency: 1 affected / 297 at risk

Adverse event: Partial Small Bowel Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: From Ovarian Cancer
Frequency: 1 affected / 297 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 297 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 297 at risk

Adverse event: Bell's palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: Worsening of Left C5-6 Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 297 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 297 at risk

Adverse event: Chronic hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 297 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 297 at risk

Adverse event: Carcinamatosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 297 at risk

Adverse event: Enterocutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Perforation bile duct
Serious: yes
Organ System: Hepatobiliary disorders
Notes: From ERCP guidewire.
Frequency: 1 affected / 297 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 297 at risk

Adverse event: Elevated Liver Function Tests
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 297 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Liver transplant rejection
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Unknown Type
Frequency: 2 affected / 297 at risk

Adverse event: Progression of malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 297 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 297 at risk

Adverse event: Abdominal Aortic Aneurysm Repair with Stent Graft
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 297 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Bile Duct Resection due to Colon Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 297 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Unknown Cardiovascular Event
Serious: yes
Organ System: Cardiac disorders
Notes: resulting in death
Frequency: 1 affected / 297 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 297 at risk

Adverse event: Transient Desaturation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 297 at risk

Adverse event: Liver Abcess
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 297 at risk

Adverse event: Probable Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Diagnosis of Cancer of the Pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 297 at risk

Adverse event: Pericarditis and effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Umbilical hernia repair
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 297 at risk

Adverse event: Duct of Luschka Biliary Leak with Extrahepatic Biliary Stricture
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 297 at risk

Adverse event: Biliary Stent Replacement
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 297 at risk

Adverse event: Esophageal Variceal Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Abdominal Distention
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 297 at risk

Adverse event: Choledocal Cyst
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Delayed Return of Bowel Function
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Biloma with Possible Superinfection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: Post ERCP Nausea
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 297 at risk

Adverse event: Intra-abdominal Hemorrhage Post Planned Surgical Intervention
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Probable Acute Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: Inflammatory Syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 297 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Dysfunction of Pancreatic Stent
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hospitalization for EUS and Abdominal Ultrasound
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hospitalization to Repeat ERCP & Continue Bile Duct Investigation
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 297 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk