Study: NCT00262119

Adverse event: Acute Cornary Syndrome/Acute Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 385 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 385 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 385 at risk

Adverse event: General cardiovascular disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 385 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 385 at risk

Adverse event: Sudden Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 385 at risk

Adverse event: Sympthoms of chest pain, angina, palpitation, dyspnea on exertion or cardiopalmo
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 385 at risk

Adverse event: Ventricular Tachycardia or Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 385 at risk

Adverse event: Glucose metabolism disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 385 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 385 at risk

Adverse event: Eye disease
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 385 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 385 at risk

Adverse event: Death for non cardiac reason
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 385 at risk

Adverse event: Death for unknown causes
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 385 at risk

Adverse event: Hemorrage
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 385 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 385 at risk

Adverse event: Other general disorders
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 385 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 385 at risk

Adverse event: Gallbladdert disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 385 at risk

Adverse event: Hepatic disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 385 at risk

Adverse event: Infection and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 385 at risk

Adverse event: Consequences of drugs administration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 385 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 385 at risk

Adverse event: Pacemaker/Lead related complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 385 at risk

Adverse event: Ureteral catheter dysfunction or dislodgement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 385 at risk

Adverse event: Enteroscopy, colonoscopy or video capsule endoscopy procedure
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 385 at risk

Adverse event: Muscoloskeletal disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 385 at risk

Adverse event: Neoplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 385 at risk

Adverse event: Prostate disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 385 at risk

Adverse event: Renal or urinary disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 385 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 385 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 385 at risk

Adverse event: Other respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 385 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 385 at risk

Adverse event: Symptoms of dyspnea, shortness of breath, fatigue, cough and or tachypnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 385 at risk

Adverse event: Ablation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 385 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 385 at risk

Adverse event: Other cardiac surgical interventions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 385 at risk

Adverse event: Other surgical interventions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 385 at risk

Adverse event: Pacemaker replacement, explant or repositioning
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 17 affected / 385 at risk

Adverse event: Stent implantation/Angiography
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 385 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 385 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 385 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 385 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 385 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 398 at risk

Adverse event: Coagulation problem
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 398 at risk

Adverse event: Acute Cornary Syndrome/Acute Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 398 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 398 at risk

Adverse event: AV conduction disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 398 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 398 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 398 at risk

Adverse event: Sudden Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 398 at risk

Adverse event: Sympthoms of chest pain, angina, palpitation, dyspnea on exertion or cardiopalmo
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 398 at risk

Adverse event: Ventricular Tachycardia or Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 398 at risk

Adverse event: Glucose metabolism disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 398 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 398 at risk

Adverse event: Death for non cardiac reason
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 398 at risk

Adverse event: Death for unknown causes
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 398 at risk

Adverse event: Hemorrage
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 398 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 398 at risk

Adverse event: Other general disorders
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 398 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 398 at risk

Adverse event: Hepatic disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 398 at risk

Adverse event: Infection and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 398 at risk

Adverse event: Consequences of drugs administration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 398 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 398 at risk

Adverse event: Pacemaker/Lead related complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 398 at risk

Adverse event: Muscoloskeletal disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 398 at risk

Adverse event: Neoplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 398 at risk

Adverse event: Prostate disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 398 at risk

Adverse event: Renal or urinary disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 398 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 398 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 398 at risk

Adverse event: Cronic Obstructive Pulmonary Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 398 at risk

Adverse event: Other respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 398 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 398 at risk

Adverse event: Symptoms of dyspnea, shortness of breath, fatigue, cough and or tachypnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 398 at risk

Adverse event: Ablation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 398 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 398 at risk

Adverse event: Other cardiac surgical interventions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 398 at risk

Adverse event: Other surgical interventions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 21 affected / 398 at risk

Adverse event: Pacemaker replacement, explant or repositioning
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 398 at risk

Adverse event: Stent implantation/Angiography
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 398 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 398 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 398 at risk

Adverse event: Other vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 398 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 398 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 398 at risk

Adverse event: Acute Cornary Syndrome/Acute Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 383 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 38 affected / 383 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 383 at risk

Adverse event: General cardiovascular disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 383 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 383 at risk

Adverse event: Sudden Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 383 at risk

Adverse event: Sympthoms of chest pain, angina, palpitation, dyspnea on exertion or cardiopalmo
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 383 at risk

Adverse event: Ventricular Tachycardia or Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 383 at risk

Adverse event: Glucose metabolism disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 383 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 383 at risk

Adverse event: Eye disease
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 383 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 383 at risk

Adverse event: Death for non cardiac reason
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 383 at risk

Adverse event: Death for unknown causes
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 383 at risk

Adverse event: Hemorrage
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 383 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 383 at risk

Adverse event: Other general disorders
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 383 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 383 at risk

Adverse event: Gallbladdert disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 383 at risk

Adverse event: Hepatic disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 383 at risk

Adverse event: Infection and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 383 at risk

Adverse event: Consequences of drugs administration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 383 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 383 at risk

Adverse event: Pacemaker/Lead related complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 383 at risk

Adverse event: Muscoloskeletal disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 383 at risk

Adverse event: Neoplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 383 at risk

Adverse event: Renal or urinary disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 383 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 383 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Cronic Obstructive Pulmonary Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Other respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 383 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 383 at risk

Adverse event: Symptoms of dyspnea, shortness of breath, fatigue, cough and or tachypnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 383 at risk

Adverse event: Ablation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 383 at risk

Adverse event: Other cardiac surgical interventions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 383 at risk

Adverse event: Other surgical interventions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 383 at risk

Adverse event: Pacemaker replacement, explant or repositioning
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 17 affected / 383 at risk

Adverse event: Stent implantation/Angiography
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 383 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 383 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 383 at risk

Adverse event: Other cerebrovascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 383 at risk

Adverse event: Other vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 383 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 383 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 383 at risk