Study: NCT00460746

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Noted by investigator as doubtfully related to study drug
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: General disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Relationship is other than not related.
Frequency: 2 affected / 10 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Relationship is other than not related.
Frequency: 3 affected / 10 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Relationship is other than not related.
Frequency: 4 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Relationship is other than not related.
Frequency: 3 affected / 10 at risk

Adverse event: Heart rate increase
Serious: no
Organ System: Vascular disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Relationship is other than not related.
Frequency: 2 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Relationship is other than not related.
Frequency: 2 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Relationship is other than not related.
Frequency: 3 affected / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Relationship is other than not related.
Frequency: 1 affected / 10 at risk