Study: NCT02618187

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 3 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 2 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 3 affected / 15 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Treatment-emergent adverse event
Frequency: 3 affected / 15 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 2 affected / 11 at risk

Adverse event: Worsening depression
Serious: yes
Organ System: Psychiatric disorders
Notes: The one case of worsening depression was reported as moderate severity, and probably not or likely not related to study drug, as determined by the investigator.
Frequency: 1 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 2 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Treatment-emergent adverse event
Frequency: 2 affected / 15 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Treatment-emergent adverse event
Frequency: 3 affected / 15 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 4 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 2 affected / 17 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 3 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 17 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 17 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Treatment-emergent adverse event
Frequency: 1 affected / 17 at risk