Study: NCT03195894

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ascites due to liver cirrhosis. Not related to device.
Frequency: 1 affected / 59 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Bleeding esophagusvarices and duodenal ulcus. Not related to device.
Frequency: 1 affected / 59 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Staphylococcus aureus sepsis. Not related to device.
Frequency: 1 affected / 59 at risk

Adverse event: Abstinence
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization due to alcohol abstinence. Not related to device.
Frequency: 6 affected / 59 at risk

Adverse event: Fainting, dizziness and nausea
Serious: yes
Organ System: General disorders
Notes: Not related to device.
Frequency: 1 affected / 59 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related to device.
Frequency: 1 affected / 59 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Not related to device.
Frequency: 1 affected / 59 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: General disorders
Notes: Intoxication, lowered consciousness and delirium. Not related to device.
Frequency: 2 affected / 59 at risk

Adverse event: Suicide attempts
Serious: yes
Organ System: Psychiatric disorders
Notes: Not related to device.
Frequency: 1 affected / 59 at risk

Adverse event: Recurrent ischemic pain
Serious: yes
Organ System: Vascular disorders
Notes: Not related to device
Frequency: 1 affected / 59 at risk

Adverse event: Cold, fever, flu
Serious: no
Organ System: Infections and infestations
Notes: Five patients reported cold, or flu-like symptoms and fever.
Frequency: 2 affected / 59 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Four patients reported pain in foot, hand, or thumb.
Frequency: 3 affected / 59 at risk

Adverse event: Abstinence
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization due to alcohol abstinence. Not related to device.
Frequency: 2 affected / 56 at risk

Adverse event: Fainting, dizziness and nausea
Serious: yes
Organ System: General disorders
Notes: Not related to device.
Frequency: 1 affected / 56 at risk

Adverse event: Suspected transient ischemic attack (TIA)
Serious: yes
Organ System: Vascular disorders
Notes: Not related to device.
Frequency: 1 affected / 56 at risk

Adverse event: Infection in foot
Serious: yes
Organ System: Infections and infestations
Notes: Infection in foot after surgery. Not related to device.
Frequency: 1 affected / 56 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Cold, fever, flu
Serious: no
Organ System: Infections and infestations
Notes: Five patients reported cold, or flu-like symptoms and fever.
Frequency: 3 affected / 56 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Four patients reported pain in foot, hand, or thumb.
Frequency: 1 affected / 56 at risk