Study: NCT00715273

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 71 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 71 at risk

Adverse event: Coronary artery bypass graft surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Cardiac disorders
Notes: Single or multiple vessel
Frequency: 10 affected / 71 at risk

Adverse event: Peripheral artery revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 71 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 71 at risk

Adverse event: Hospitalized for worsening ischemia
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for worsening cardiac ischemia but no revascularization
Frequency: 7 affected / 71 at risk

Adverse event: Hospitalized for transient ischemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 71 at risk

Adverse event: Hospitalized for heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Death - Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 71 at risk

Adverse event: Death - myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Death - Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 71 at risk

Adverse event: Death - Other/Multiple/Unknown
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 71 at risk

Adverse event: New onset Type 2 Diabetes Melitus
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 61 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Sinus infection with or without antibiotic use
Frequency: 6 affected / 71 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 5 affected / 71 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 71 at risk

Adverse event: Diseased or injured knee joint requiring surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 71 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 71 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 71 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 71 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 71 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 71 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 71 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 73 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Coronary artery bypass graft surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 73 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Cardiac disorders
Notes: Single or multiple vessel
Frequency: 6 affected / 73 at risk

Adverse event: Peripheral artery revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 73 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 73 at risk

Adverse event: Hospitalized for worsening ischemia
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for worsening cardiac ischemia but no revascularization
Frequency: 7 affected / 73 at risk

Adverse event: Hospitalized for transient ischemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 73 at risk

Adverse event: Death - Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 73 at risk

Adverse event: Death - myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Death - Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Death - Idiopathic Pulmonary Fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Death - Other/Multiple/Unknown
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 73 at risk

Adverse event: Diseased or injured hip joint requiring replacement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 73 at risk

Adverse event: New onset Type 2 Diabetes Melitus
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 60 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 7 affected / 73 at risk

Adverse event: Diseased or injured knee joint requiring surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 73 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 73 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 73 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 73 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 73 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 73 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 73 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 73 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 73 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 73 at risk

Adverse event: Coronary artery bypass graft surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 73 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Cardiac disorders
Notes: Single or multiple vessel
Frequency: 8 affected / 73 at risk

Adverse event: Peripheral artery revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 73 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 73 at risk

Adverse event: Hospitalized for worsening ischemia
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for worsening cardiac ischemia but no revascularization
Frequency: 5 affected / 73 at risk

Adverse event: Hospitalized for transient ischemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hospitalized for heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Death - Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 73 at risk

Adverse event: Death - Intentional self-harm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Diseased or injured hip joint requiring replacement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 73 at risk

Adverse event: New onset Type 2 Diabetes Melitus
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 64 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Sinus infection with or without antibiotic use
Frequency: 2 affected / 73 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 3 affected / 73 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 6 affected / 73 at risk

Adverse event: Diseased or injured knee joint requiring surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 73 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 73 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 73 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 73 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 73 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 73 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 73 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 73 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 73 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk