Study: NCT01385176

Adverse event: HF hospitalization, anticipated
Serious: yes
Organ System: Cardiac disorders
Notes: anticipated Heart Failure hospitalizations
Frequency: 7 affected / 63 at risk

Adverse event: Cardiovascular - Non Heart Failure, anticipated
Serious: yes
Organ System: Cardiac disorders
Notes: anticipated Cardiovascular Serious Adverse events, which were not related to Heart Failure
Frequency: 7 affected / 63 at risk

Adverse event: Genitourinary, anticipated
Serious: yes
Organ System: Renal and urinary disorders
Notes: anticipated Genitourinary Serious Adverse Events
Frequency: 1 affected / 63 at risk

Adverse event: Other Non Cardiocascular, anticipated
Serious: yes
Organ System: General disorders
Notes: Other anticipated Non Cardiocascular serious adverse events
Frequency: 7 affected / 63 at risk

Adverse event: Investigational device system related, anticipated
Serious: yes
Organ System: Product Issues
Notes: anticipated Investigational device system related serious adverse device effects
Frequency: 9 affected / 63 at risk

Adverse event: Death, anticipated
Serious: yes
Organ System: Cardiac disorders
Notes: anticpated death due to any cause
Frequency: 1 affected / 63 at risk

Adverse event: Cardiovascular HF related, anticipated
Serious: no
Organ System: Cardiac disorders
Notes: anticipated Cardiovascular Heart Failure related non serious adverse events
Frequency: 15 affected / 63 at risk

Adverse event: Cardiovascular - not HF related, anticipated
Serious: no
Organ System: Cardiac disorders
Notes: anticipated Cardiovascular - not Heart Failure related adverse events
Frequency: 21 affected / 63 at risk

Adverse event: Pulmonary non serious adverse events, anticipated
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: anticipated Pulmonary non serious adverse events (non-cardiovascular)
Frequency: 2 affected / 63 at risk

Adverse event: Genitourinary, anticipated
Serious: no
Organ System: Renal and urinary disorders
Notes: Genitourinary non - serious, anticipated
Frequency: 1 affected / 63 at risk

Adverse event: Other Non-cardiovascular, anticipated
Serious: no
Organ System: General disorders
Notes: Other Non-cardiovascular non-serious adverse events, anticipated
Frequency: 19 affected / 63 at risk

Adverse event: Investigational System-Related anticipated
Serious: no
Organ System: Investigations
Notes: Investigational System-Related non-serious adverse events, anticipated
Frequency: 32 affected / 63 at risk

Adverse event: HF hospitalization, anticipated
Serious: yes
Organ System: Cardiac disorders
Notes: anticipated Heart Failure hospitalizations
Frequency: 5 affected / 32 at risk

Adverse event: Cardiovascular - Non Heart Failure, anticipated
Serious: yes
Organ System: Cardiac disorders
Notes: anticipated Cardiovascular Serious Adverse events, which were not related to Heart Failure
Frequency: 5 affected / 32 at risk

Adverse event: Pulmonary Serious Adverse Events, anticipated
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: anticipated Pulmonary Serious Adverse Events
Frequency: 3 affected / 32 at risk

Adverse event: Genitourinary, anticipated
Serious: yes
Organ System: Renal and urinary disorders
Notes: anticipated Genitourinary Serious Adverse Events
Frequency: 2 affected / 32 at risk

Adverse event: Other Non Cardiocascular, anticipated
Serious: yes
Organ System: General disorders
Notes: Other anticipated Non Cardiocascular serious adverse events
Frequency: 7 affected / 32 at risk

Adverse event: Investigational device system related, anticipated
Serious: yes
Organ System: Product Issues
Notes: anticipated Investigational device system related serious adverse device effects
Frequency: 4 affected / 32 at risk

Adverse event: Death, anticipated
Serious: yes
Organ System: Cardiac disorders
Notes: anticpated death due to any cause
Frequency: 2 affected / 32 at risk

Adverse event: Cardiovascular HF related, anticipated
Serious: no
Organ System: Cardiac disorders
Notes: anticipated Cardiovascular Heart Failure related non serious adverse events
Frequency: 7 affected / 32 at risk

Adverse event: Cardiovascular - not HF related, anticipated
Serious: no
Organ System: Cardiac disorders
Notes: anticipated Cardiovascular - not Heart Failure related adverse events
Frequency: 13 affected / 32 at risk

Adverse event: Pulmonary non serious adverse events, anticipated
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: anticipated Pulmonary non serious adverse events (non-cardiovascular)
Frequency: 2 affected / 32 at risk

Adverse event: Genitourinary, anticipated
Serious: no
Organ System: Renal and urinary disorders
Notes: Genitourinary non - serious, anticipated
Frequency: 1 affected / 32 at risk

Adverse event: Other Non-cardiovascular, anticipated
Serious: no
Organ System: General disorders
Notes: Other Non-cardiovascular non-serious adverse events, anticipated
Frequency: 13 affected / 32 at risk

Adverse event: Investigational System-Related anticipated
Serious: no
Organ System: Investigations
Notes: Investigational System-Related non-serious adverse events, anticipated
Frequency: 11 affected / 32 at risk

Adverse event: HF hospitalization, anticipated
Serious: yes
Organ System: Cardiac disorders
Notes: anticipated Heart Failure hospitalizations
Frequency: 18 affected / 92 at risk

Adverse event: Cardiovascular - Non Heart Failure, anticipated
Serious: yes
Organ System: Cardiac disorders
Notes: anticipated Cardiovascular Serious Adverse events, which were not related to Heart Failure
Frequency: 16 affected / 92 at risk

Adverse event: Pulmonary Serious Adverse Events, anticipated
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: anticipated Pulmonary Serious Adverse Events
Frequency: 5 affected / 92 at risk

Adverse event: Genitourinary, anticipated
Serious: yes
Organ System: Renal and urinary disorders
Notes: anticipated Genitourinary Serious Adverse Events
Frequency: 1 affected / 92 at risk

Adverse event: Other Non Cardiocascular, anticipated
Serious: yes
Organ System: General disorders
Notes: Other anticipated Non Cardiocascular serious adverse events
Frequency: 22 affected / 92 at risk

Adverse event: Investigational device system related, anticipated
Serious: yes
Organ System: Product Issues
Notes: anticipated Investigational device system related serious adverse device effects
Frequency: 2 affected / 92 at risk

Adverse event: Investigational device system related, unanticipated
Serious: yes
Organ System: Product Issues
Notes: unanticipated Investigational device system related
Frequency: 1 affected / 92 at risk

Adverse event: Death, anticipated
Serious: yes
Organ System: Cardiac disorders
Notes: anticpated death due to any cause
Frequency: 3 affected / 92 at risk

Adverse event: Cardiovascular HF related, anticipated
Serious: no
Organ System: Cardiac disorders
Notes: anticipated Cardiovascular Heart Failure related non serious adverse events
Frequency: 21 affected / 92 at risk

Adverse event: Cardiovascular - not HF related, anticipated
Serious: no
Organ System: Cardiac disorders
Notes: anticipated Cardiovascular - not Heart Failure related adverse events
Frequency: 28 affected / 92 at risk

Adverse event: Pulmonary non serious adverse events, anticipated
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: anticipated Pulmonary non serious adverse events (non-cardiovascular)
Frequency: 8 affected / 92 at risk

Adverse event: Genitourinary, anticipated
Serious: no
Organ System: Renal and urinary disorders
Notes: Genitourinary non - serious, anticipated
Frequency: 3 affected / 92 at risk

Adverse event: Other Non-cardiovascular, anticipated
Serious: no
Organ System: General disorders
Notes: Other Non-cardiovascular non-serious adverse events, anticipated
Frequency: 34 affected / 92 at risk

Adverse event: Investigational System-Related anticipated
Serious: no
Organ System: Investigations
Notes: Investigational System-Related non-serious adverse events, anticipated
Frequency: 25 affected / 92 at risk