Study: NCT03447730

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 1
Frequency: 2 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 2
Frequency: 2 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 2
Frequency: 3 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 2
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Maximum severity Grade 2
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Maximum severity Grade 2
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Maximum severity Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Maximum severity Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 1
Frequency: 4 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 2
Frequency: 4 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 2
Frequency: 3 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 2
Frequency: 2 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 2
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 2
Frequency: 1 affected / 9 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 1
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Maximum severity Grade 2
Frequency: 2 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Maximum severity Grade 2
Frequency: 2 affected / 9 at risk

Adverse event: Hepatic encephalopathy
Serious: no
Organ System: Nervous system disorders
Notes: Maximum severity Grade 2
Frequency: 2 affected / 9 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: Maximum severity Grade 1
Frequency: 1 affected / 9 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maximum severity Grade 2
Frequency: 2 affected / 9 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Maximum severity Grade 2
Frequency: 1 affected / 9 at risk

Adverse event: Traumatic pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Maximum severity Grade 2
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Maximum severity Grade 1
Frequency: 1 affected / 9 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Severity Grade 3
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maximum severity Grade 2
Frequency: 1 affected / 8 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Maximum severity Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Maximum severity Grade 2
Frequency: 1 affected / 8 at risk