Study: NCT00794573

Adverse event: Major Adverse Cardiovascular Event (Any)
Serious: yes
Organ System: Cardiac disorders
Notes: cardiovascular death, myocardial infarction, or unstable angina
Frequency: 6 affected / 151 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 151 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Hospitalization for Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 151 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Hospitalization for Suspected Unstable Angina - Ruled Out by Angiogram
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 151 at risk

Adverse event: Septic Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Hospitalization for Bowel Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 151 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sternal Wound Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Cardiovascular Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 21 affected / 151 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 23 affected / 151 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Frequency: 14 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 151 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 6 affected / 151 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 8 affected / 151 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 151 at risk

Adverse event: Major Adverse Cardiovascular Event (Any)
Serious: yes
Organ System: Cardiac disorders
Notes: cardiovascular death, myocardial infarction, or unstable angina
Frequency: 7 affected / 151 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 151 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 151 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Ruptured Pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Acute Exacerbation of Chronic Obstructive Pulmonary Disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Exacerbation of Rheumatoid Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Motor Vehicle Collision
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 13 affected / 151 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 7 affected / 151 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Frequency: 7 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 151 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 13 affected / 151 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 9 affected / 151 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 151 at risk