Study: NCT03694210

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Moderate severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Moderate severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Moderate severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Moderate severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Event 1: Severe severity, not related to device, possible relationship to procedure Event 2: Moderate severity, not related to device, possible relationship to procedure
Frequency: 2 affected / 30 at risk

Adverse event: Pneumoperitoneum
Serious: yes
Organ System: Surgical and medical procedures
Notes: Mild severity, not related to device, possible relationship to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Multiple Organ Failure Syndrome
Serious: yes
Organ System: General disorders
Notes: Severe severity, not related to device, not related to procedure. Patient later deceased
Frequency: 1 affected / 30 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Severe severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Moderate severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Notes: Moderate severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild severity, no related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Oesophageal candidiasis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Moderate severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Clostridium difficile infection
Serious: no
Organ System: Infections and infestations
Notes: Moderate severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Mild severity, not related to device, not related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Device Dislocation (LAMS dislodgement)
Serious: no
Organ System: Product Issues
Notes: Mild severity, not related to device, definitely related to procedure
Frequency: 1 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Vascular disorders
Notes: Moderate severity, not related to device possible relationship to procedure
Frequency: 1 affected / 30 at risk