Study: NCT00377676

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac Disorders include: Coronary Artery Disease, Chest Pain, Cardiac failure congestive, Myocardial Infarction, Angina Unstable, Atrial Fibrillation, Syncope, Acute Myocardial Infarction
Frequency: 51 affected / 2054 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection includes: Pneumonia, Cellulitis, Diverticulitis
Frequency: 27 affected / 2054 at risk

Adverse event: Nervousness
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous system disorders include: Syncope, Cerebrovascular accident, Transient ischemic attack
Frequency: 26 affected / 2054 at risk

Adverse event: General disorders and adminstrative site conditions
Serious: yes
Organ System: General disorders
Notes: General disorders and administrative site conditions include: Chest pain, non-cardiac chest pain
Frequency: 14 affected / 2054 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders include: Gastrointestinal hemorrhage
Frequency: 13 affected / 2054 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Notes: Vascular disorders include: Carotid artery stenosis
Frequency: 10 affected / 2054 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory, thoracic and mediastinal disorders include: Chronic obstructive pulmonary disease
Frequency: 13 affected / 2054 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 2054 at risk

Adverse event: Musculoskeletal and connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 2054 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 2054 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Notes: Endocrine disorders include: hypoglycemia
Frequency: 5 affected / 2054 at risk

Adverse event: Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Metabolism and nutrition disorders include: Dehydration
Frequency: 7 affected / 2054 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal and urinary disorders include: acute renal failure
Frequency: 6 affected / 2054 at risk

Adverse event: Hepatobiliary
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 2054 at risk

Adverse event: Pyschiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 2054 at risk

Adverse event: Reproductive
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 2054 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 661 affected / 2054 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 167 affected / 2054 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 303 affected / 2054 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 235 affected / 2054 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 285 affected / 2054 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 119 affected / 2054 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 141 affected / 2054 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac Disorders include: Coronary Artery Disease, Chest Pain, Cardiac failure congestive, Myocardial Infarction, Angina Unstable, Atrial Fibrillation, Syncope, Acute Myocardial Infarction
Frequency: 37 affected / 1016 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection includes: Pneumonia, Cellulitis, Diverticulitis
Frequency: 13 affected / 1016 at risk

Adverse event: Nervousness
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous system disorders include: Syncope, Cerebrovascular accident, Transient ischemic attack
Frequency: 14 affected / 1016 at risk

Adverse event: General disorders and adminstrative site conditions
Serious: yes
Organ System: General disorders
Notes: General disorders and administrative site conditions include: Chest pain, non-cardiac chest pain
Frequency: 9 affected / 1016 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal disorders include: Gastrointestinal hemorrhage
Frequency: 9 affected / 1016 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Notes: Vascular disorders include: Carotid artery stenosis
Frequency: 8 affected / 1016 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory, thoracic and mediastinal disorders include: Chronic obstructive pulmonary disease
Frequency: 3 affected / 1016 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1016 at risk

Adverse event: Musculoskeletal and connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1016 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1016 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Notes: Endocrine disorders include: hypoglycemia
Frequency: 4 affected / 1016 at risk

Adverse event: Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Metabolism and nutrition disorders include: Dehydration
Frequency: 2 affected / 1016 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal and urinary disorders include: acute renal failure
Frequency: 3 affected / 1016 at risk

Adverse event: Hepatobiliary
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1016 at risk

Adverse event: Pyschiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1016 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Notes: Eye disorders include: retinal detachment
Frequency: 2 affected / 1016 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 1016 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 1016 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 63 affected / 1016 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 84 affected / 1016 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 68 affected / 1016 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 1016 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 54 affected / 1016 at risk