Study: NCT01086228

Adverse event: Mild: bleeding that is not moderate nor severe
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 2009 at risk

Adverse event: Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 2009 at risk

Adverse event: Severe/Life Threatening (either intracranial hemorrhage or bleeding that causes hemodynamic compromi
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 2009 at risk

Adverse event: Abnormal stress test
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 2009 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 2009 at risk

Adverse event: Angina-equivalent symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 108 affected / 2009 at risk

Adverse event: Arrhythmia of unknown reason
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 2009 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 2009 at risk

Adverse event: Cardiac: other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 2009 at risk

Adverse event: Conduction disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 2009 at risk

Adverse event: Elevated cardiac enzymes
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 2009 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 86 affected / 2009 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 2009 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 2009 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 158 affected / 2009 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 244 affected / 2009 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 2009 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Valve disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 2009 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 2009 at risk

Adverse event: Biliary/liver disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 2009 at risk

Adverse event: Gastroesophageal reflux disease, diarrhea, nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 2009 at risk

Adverse event: Other gastro-intestinal symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 2009 at risk

Adverse event: Pancreatic disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 2009 at risk

Adverse event: Abnormal Lab Test (Non-cardiac):Abnormal CBC with differentials
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 2009 at risk

Adverse event: Abnormal Lab Test (Non-cardiac):Abnormal liver enzymes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Abnormal Lab Test (Non-cardiac):Abnormal other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 2009 at risk

Adverse event: Contusion
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Death of unknown reason
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 2009 at risk

Adverse event: Eye/ear/nose/throat disorder
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 2009 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2009 at risk

Adverse event: General/Musculoskeletal/ Connective: Other
Serious: yes
Organ System: General disorders
Frequency: 29 affected / 2009 at risk

Adverse event: Outcome to Death
Serious: yes
Organ System: General disorders
Frequency: 138 affected / 2009 at risk

Adverse event: Weakness/fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Allergic Reaction to antiplatelet Agent
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Allergic Reaction to contrast
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Local infection
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 2009 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 2009 at risk

Adverse event: Wound infection/abnormal healing
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 2009 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 2009 at risk

Adverse event: Hyper/hypoglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Thyroid disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Ache/ myalgia/ pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Bone or joint injury/disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 2009 at risk

Adverse event: Oedema
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 15 affected / 2009 at risk

Adverse event: Cancer and tumour: other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2009 at risk

Adverse event: Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 100 affected / 2009 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 2009 at risk

Adverse event: Headache/migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Nerve/Psychiatric Disorders : Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 2009 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Sleep disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Stroke/CVA
Serious: yes
Organ System: Nervous system disorders
Frequency: 36 affected / 2009 at risk

Adverse event: Syncope/fainting
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 2009 at risk

Adverse event: Genito-urinary and renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 40 affected / 2009 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 2009 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2009 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 50 affected / 2009 at risk

Adverse event: Respiratory System: other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 2009 at risk

Adverse event: Respiratory insufficiency/failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 2009 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Rash/Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2009 at risk

Adverse event: skin/subcutaneous disorder: other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 2009 at risk

Adverse event: Abrupt closure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 2009 at risk

Adverse event: Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 2009 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 2009 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 2009 at risk

Adverse event: No/slow reflow
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 2009 at risk

Adverse event: Perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 35 affected / 2009 at risk

Adverse event: Spasm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Thrombosis - non stent
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 2009 at risk

Adverse event: Vascular: other
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 2009 at risk

Adverse event: Mild: bleeding that is not moderate nor severe
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Bleeding
Frequency: 1 affected / 2009 at risk

Adverse event: Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Bleeding
Frequency: 1 affected / 2009 at risk

Adverse event: Abnormal stress test
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 2009 at risk

Adverse event: Angina-equivalent symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 2009 at risk

Adverse event: Arrhythmia of unknown reason
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 2009 at risk

Adverse event: Conduction disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Elevated cardiac enzymes
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 2009 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Restenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 44 affected / 2009 at risk

Adverse event: Stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 2009 at risk

Adverse event: Vascular stent thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 2009 at risk

Adverse event: Biliary/liver disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Gastro-intestinal disorder (e.g. GERD, diarrhea, nausea)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2009 at risk

Adverse event: General/Musculoskeletal/ Connective : Other
Serious: no
Organ System: General disorders
Notes: Except bone or joint injury/disorder and Non cardiac chest pain.
Frequency: 4 affected / 2009 at risk

Adverse event: Allergic Reaction:To antiplatelet Agent
Serious: no
Organ System: Immune system disorders
Notes: Allergic Reaction
Frequency: 1 affected / 2009 at risk

Adverse event: Wound infection/abnormal healing
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2009 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Metabolism/endocrine
Frequency: 1 affected / 2009 at risk

Adverse event: Hyper/hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Metabolism/endocrine
Frequency: 1 affected / 2009 at risk

Adverse event: Bone or joint injury/disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systemic/musculoskeletal/connective tissue disorder
Frequency: 4 affected / 2009 at risk

Adverse event: Benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Cancer and Tumor
Frequency: 1 affected / 2009 at risk

Adverse event: Malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Cancer and Tumor
Frequency: 2 affected / 2009 at risk

Adverse event: Nerve/psychiatric disorders : Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Genito-urinary and renal disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Respiratory/Pulmonary disorders : Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Dissection
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 2009 at risk

Adverse event: Jailing of side branch
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2009 at risk

Adverse event: No/slow reflow
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Perforation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2009 at risk

Adverse event: Peripheral artery disease (PAD)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Spasm
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 2009 at risk

Adverse event: Thrombosis - non stent
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2009 at risk