Study: NCT01930214

Adverse event: Acute MI, non Q-wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 134 at risk

Adverse event: Acute congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 134 at risk

Adverse event: Arrhythmia, unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 134 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 134 at risk

Adverse event: Chest Pain, non ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 134 at risk

Adverse event: Chronic CHF, or exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 134 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 134 at risk

Adverse event: Elevated Troponin
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Other cardiovascular system related AE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 134 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Abrupt or threatened closure of coronary artery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 1 affected / 134 at risk

Adverse event: Coronary vessel dissection present (A-F)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 12 affected / 134 at risk

Adverse event: Coronary vessel perforation present
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 1 affected / 134 at risk

Adverse event: Slow flow or no reflow phenomena
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 3 affected / 134 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Hematoma at access site, not requiring intervention
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 134 at risk

Adverse event: Hemorrhage, major, requiring transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Hemorrhage, minor, without transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 134 at risk

Adverse event: Peripheral artery pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Peripheral artery/vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 134 at risk

Adverse event: Dyspnea/Shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 134 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Infection, systemic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Other infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 134 at risk

Adverse event: Other patient condition related AE
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 134 at risk

Adverse event: Non-Cardiac Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 134 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 134 at risk

Adverse event: Acute MI, non Q-wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 99 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 99 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 99 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 99 at risk

Adverse event: Chest Pain, non ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 99 at risk

Adverse event: Chronic CHF, or exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 99 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Elevated CK-MB
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Elevated cardiac enzymes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Other cardiovascular system related AE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Coronary artery vasospasm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 1 affected / 99 at risk

Adverse event: Coronary vessel dissection present (A-F)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 16 affected / 99 at risk

Adverse event: Hematoma at access site, not requiring intervention
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 99 at risk

Adverse event: Hemorrhage, minor, without transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 99 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 99 at risk

Adverse event: Peripheral artery pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 99 at risk

Adverse event: Peripheral artery/vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 99 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Dyspnea/Shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Allergic reaction to contrast dye
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Other index procedure related AE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Other patient condition related AE
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Non-Cardiac Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Acute MI, Q-wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Acute MI, non Q-wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 117 at risk

Adverse event: Acute congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 117 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 117 at risk

Adverse event: Atrioventricular block, III degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Chest Pain, non ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 117 at risk

Adverse event: Chronic CHF, or exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 117 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 117 at risk

Adverse event: Elevated CK-MB
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Elevated Troponin
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Other cardiovascular system related AE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Abrupt or threatened closure of coronary artery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 2 affected / 117 at risk

Adverse event: Coronary vessel dissection present (A-F)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 25 affected / 117 at risk

Adverse event: Coronary vessel perforation present
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 1 affected / 117 at risk

Adverse event: Slow flow or no reflow phenomena
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Angiographic complications
Frequency: 2 affected / 117 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hematoma at access site, not requiring intervention
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 117 at risk

Adverse event: Hemorrhage, major, requiring transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 117 at risk

Adverse event: Hemorrhage, minor, without transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 117 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 117 at risk

Adverse event: Peripheral artery pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 117 at risk

Adverse event: Peripheral vessel damage requiring surgical repair
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 117 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Dyspnea/Shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 117 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Infection, systemic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Other patient condition related AE
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 117 at risk

Adverse event: Non-Cardiac Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 117 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 117 at risk