Study: NCT00683696

Adverse event: Worsening heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 101 affected / 404 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 404 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 404 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 404 at risk

Adverse event: Other cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 404 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 404 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 404 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 58 affected / 404 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 404 at risk

Adverse event: Other noncardiovascular
Serious: yes
Organ System: General disorders
Frequency: 40 affected / 404 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 404 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 28 affected / 404 at risk

Adverse event: Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 404 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 404 at risk

Adverse event: ICD lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 404 at risk

Adverse event: Lead for right atrial pacing
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 404 at risk

Adverse event: Lead for left ventricular pacing
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 404 at risk

Adverse event: Implantation related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 17 affected / 404 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 404 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 404 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 404 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 404 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 404 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 404 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 404 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 404 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 404 at risk

Adverse event: Transischemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 404 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 404 at risk

Adverse event: Fluid accumulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 404 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 404 at risk

Adverse event: Catheterisation cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 404 at risk

Adverse event: Cardiovascular medication related
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 404 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 404 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 404 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 404 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 404 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Increased INR
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 404 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 404 at risk

Adverse event: Fatigue
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 12 affected / 404 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 404 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 404 at risk

Adverse event: Hepatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 404 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 404 at risk

Adverse event: Device related
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 404 at risk

Adverse event: Worsening heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 404 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 39 affected / 404 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 33 affected / 404 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 404 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 404 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 404 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 404 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 404 at risk

Adverse event: Non-cardiovascular
Serious: no
Organ System: General disorders
Frequency: 203 affected / 404 at risk

Adverse event: Implant Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 31 affected / 404 at risk

Adverse event: ICD lead
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 404 at risk

Adverse event: Lead for left ventricular pacing
Serious: no
Organ System: Cardiac disorders
Frequency: 49 affected / 404 at risk

Adverse event: Worsening heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 93 affected / 405 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 405 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 405 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 405 at risk

Adverse event: Other cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 405 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 405 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 405 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 45 affected / 405 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 405 at risk

Adverse event: Other noncardiovascular
Serious: yes
Organ System: General disorders
Frequency: 36 affected / 405 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 405 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 16 affected / 405 at risk

Adverse event: Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 405 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 405 at risk

Adverse event: ICD lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 405 at risk

Adverse event: Lead for right atrial pacing
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 405 at risk

Adverse event: Lead for left ventricular pacing
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 405 at risk

Adverse event: Implantation related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 405 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 405 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 405 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 405 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 405 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 405 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 405 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 405 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 405 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 405 at risk

Adverse event: Transischemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 405 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 405 at risk

Adverse event: Fluid accumulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 405 at risk

Adverse event: Catheterisation cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 405 at risk

Adverse event: Cardiovascular medication related
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 405 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 405 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 405 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 405 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 405 at risk

Adverse event: Increased INR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 405 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 405 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 405 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 405 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 405 at risk

Adverse event: Hepatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 405 at risk

Adverse event: Device related
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 405 at risk

Adverse event: Worsening heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 405 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 405 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 405 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 405 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 405 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 405 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 405 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 405 at risk

Adverse event: Non-cardiovascular
Serious: no
Organ System: General disorders
Frequency: 201 affected / 405 at risk

Adverse event: Implant Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 41 affected / 405 at risk

Adverse event: ICD lead
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 405 at risk

Adverse event: Lead for left ventricular pacing
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 405 at risk