Study: NCT01685684

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1297 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1297 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 740 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 740 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 740 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Notes: Not related to study drug as assessed by Principal Investigator and Medical Monitor
Frequency: 1 affected / 740 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 740 at risk

Adverse event: Pituitary tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 740 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 740 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 740 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 123 affected / 740 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 103 affected / 740 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 96 affected / 740 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 65 affected / 740 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 55 affected / 740 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 47 affected / 740 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 42 affected / 740 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 193 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 21 affected / 193 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 12 affected / 193 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 10 affected / 193 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 1 affected / 193 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 5 affected / 193 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 8 affected / 193 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 3 affected / 193 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 196 at risk

Adverse event: Benign hydatidiform mole
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 196 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 9 affected / 196 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 23 affected / 196 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 1 affected / 196 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 3 affected / 196 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-serious Adverse Events were not collected during screening.
Frequency: 3 affected / 196 at risk