Study: NCT02318134

Adverse event: Infected pancreatic necrosis
Serious: yes
Organ System: Infections and infestations
Notes: Positive culture of peripancreatic fluid or pancreatic necrosis obtained by either fine-needle aspiration or during the first percutaneous or endoscopic drainage
Frequency: 4 affected / 30 at risk

Adverse event: Persistent respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PaO2/FiO2 below 300
Frequency: 24 affected / 30 at risk

Adverse event: Persistent renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Serum Creatinine over 170 μmol/l or 1.9 mg/dl
Frequency: 3 affected / 30 at risk

Adverse event: Persistent circulatory failure
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic blood pressure below 90 mm Hg, not fluid responsive or pH below 7.3
Frequency: 9 affected / 30 at risk

Adverse event: Gastrointestinal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: infected ascites
Serious: no
Organ System: Infections and infestations
Notes: bacteria or fungi detected in aspirate of intraperitoneal fluid
Frequency: 2 affected / 30 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Notes: positive blood culture
Frequency: 9 affected / 30 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Positive sputum or endotracheal culture
Frequency: 6 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Positive urine culture
Frequency: 3 affected / 30 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infected pancreatic necrosis
Serious: yes
Organ System: Infections and infestations
Notes: Positive culture of peripancreatic fluid or pancreatic necrosis obtained by either fine-needle aspiration or during the first percutaneous or endoscopic drainage
Frequency: 8 affected / 30 at risk

Adverse event: Persistent respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PaO2/FiO2 below 300
Frequency: 21 affected / 30 at risk

Adverse event: Persistent renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Serum Creatinine over 170 μmol/l or 1.9 mg/dl
Frequency: 5 affected / 30 at risk

Adverse event: Persistent circulatory failure
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic blood pressure below 90 mm Hg, not fluid responsive or pH below 7.3
Frequency: 11 affected / 30 at risk

Adverse event: Gastrointestinal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: infected ascites
Serious: no
Organ System: Infections and infestations
Notes: bacteria or fungi detected in aspirate of intraperitoneal fluid
Frequency: 2 affected / 30 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Notes: positive blood culture
Frequency: 10 affected / 30 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Positive sputum or endotracheal culture
Frequency: 8 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Positive urine culture
Frequency: 7 affected / 30 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 30 at risk