Study: NCT01668667

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated treatment emergent SAE
Frequency: 1 affected / 122 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 13 affected / 122 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 11 affected / 122 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 15 affected / 122 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment Emergent AE
Frequency: 6 affected / 122 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment Emergent AE
Frequency: 5 affected / 122 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Treatment Emergent AE
Frequency: 5 affected / 122 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 20 affected / 123 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 9 affected / 123 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 8 affected / 123 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment Emergent AE
Frequency: 10 affected / 123 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment Emergent AE
Frequency: 4 affected / 123 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Treatment Emergent AE
Frequency: 5 affected / 123 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated treatment emergent SAE
Frequency: 1 affected / 121 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Notes: Unrelated treatment emergent SAE
Frequency: 1 affected / 121 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 12 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 10 affected / 121 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 5 affected / 121 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment Emergent AE
Frequency: 3 affected / 121 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment Emergent AE
Frequency: 3 affected / 121 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated treatment emergent SAE
Frequency: 1 affected / 121 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 8 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 12 affected / 121 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Treatment Emergent AE
Frequency: 5 affected / 121 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Treatment Emergent AE
Frequency: 7 affected / 121 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment Emergent AE
Frequency: 7 affected / 121 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Treatment Emergent AE
Frequency: 7 affected / 121 at risk