Study: NCT00559988

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 136 affected / 1357 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 64 affected / 1357 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 42 affected / 1357 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 17 affected / 1357 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 28 affected / 1357 at risk

Adverse event: Myocardial infaction
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 26 affected / 1357 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization or resulting in death
Frequency: 23 affected / 1357 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: With hospitalization, resulting in death, or persistent/significant disability
Frequency: 22 affected / 1357 at risk

Adverse event: Gastrointestianal bleeding
Serious: yes
Organ System: Vascular disorders
Notes: With hospitalization or results in death
Frequency: 23 affected / 1357 at risk

Adverse event: Upgrade to CRT-D device
Serious: yes
Organ System: Surgical and medical procedures
Notes: With hospitalization
Frequency: 25 affected / 1357 at risk

Adverse event: Device replacement
Serious: yes
Organ System: Surgical and medical procedures
Notes: With hospitalization
Frequency: 15 affected / 1357 at risk

Adverse event: Lead replacement or repositioning
Serious: yes
Organ System: Surgical and medical procedures
Notes: With hospitalization
Frequency: 16 affected / 1357 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring hospitalization
Frequency: 22 affected / 1357 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring hospitalization
Frequency: 52 affected / 1357 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring hospitalization
Frequency: 32 affected / 1357 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring hospitalization
Frequency: 19 affected / 1357 at risk

Adverse event: Device replacement
Serious: no
Organ System: Surgical and medical procedures
Notes: Done as an outpatient procedure (not requiring hospitalization)
Frequency: 29 affected / 1357 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 127 affected / 1361 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 63 affected / 1361 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 53 affected / 1361 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 26 affected / 1361 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 18 affected / 1361 at risk

Adverse event: Myocardial infaction
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization
Frequency: 35 affected / 1361 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: With hospitalization or resulting in death
Frequency: 27 affected / 1361 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: With hospitalization, resulting in death, or persistent/significant disability
Frequency: 30 affected / 1361 at risk

Adverse event: Gastrointestianal bleeding
Serious: yes
Organ System: Vascular disorders
Notes: With hospitalization or results in death
Frequency: 18 affected / 1361 at risk

Adverse event: Upgrade to CRT-D device
Serious: yes
Organ System: Surgical and medical procedures
Notes: With hospitalization
Frequency: 18 affected / 1361 at risk

Adverse event: Device replacement
Serious: yes
Organ System: Surgical and medical procedures
Notes: With hospitalization
Frequency: 9 affected / 1361 at risk

Adverse event: Lead replacement or repositioning
Serious: yes
Organ System: Surgical and medical procedures
Notes: With hospitalization
Frequency: 11 affected / 1361 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring hospitalization
Frequency: 25 affected / 1361 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring hospitalization
Frequency: 53 affected / 1361 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring hospitalization
Frequency: 34 affected / 1361 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Notes: Not requiring hospitalization
Frequency: 18 affected / 1361 at risk

Adverse event: Device replacement
Serious: no
Organ System: Surgical and medical procedures
Notes: Done as an outpatient procedure (not requiring hospitalization)
Frequency: 35 affected / 1361 at risk