Study: NCT00811382

Adverse event: Device related SAEs
Serious: yes
Organ System: Cardiac disorders
Notes: It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related".
Frequency: 12 affected / 88 at risk

Adverse event: maybe device-related SAEs
Serious: yes
Organ System: Cardiac disorders
Notes: It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related".
Frequency: 3 affected / 88 at risk

Adverse event: not device-related SAEs
Serious: yes
Organ System: Cardiac disorders
Notes: It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related".
Frequency: 39 affected / 88 at risk

Adverse event: device-related AEs
Serious: no
Organ System: Cardiac disorders
Notes: It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related".
Frequency: 5 affected / 88 at risk

Adverse event: maybe device-related AEs
Serious: no
Organ System: Cardiac disorders
Notes: It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related".
Frequency: 1 affected / 88 at risk

Adverse event: Device related SAEs
Serious: yes
Organ System: Cardiac disorders
Notes: It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related".
Frequency: 9 affected / 75 at risk

Adverse event: not device-related SAEs
Serious: yes
Organ System: Cardiac disorders
Notes: It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related".
Frequency: 36 affected / 75 at risk

Adverse event: device-related AEs
Serious: no
Organ System: Cardiac disorders
Notes: It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related".
Frequency: 6 affected / 75 at risk

Adverse event: maybe device-related AEs
Serious: no
Organ System: Cardiac disorders
Notes: It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related".
Frequency: 2 affected / 75 at risk