Study: NCT02866669

Adverse event: Any ED Visit
Serious: yes
Organ System: General disorders
Frequency: 108 affected / 342 at risk

Adverse event: Any hospitalization
Serious: yes
Organ System: General disorders
Frequency: 45 affected / 342 at risk

Adverse event: Self reported falls with Ed visit
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 342 at risk

Adverse event: Self reported stroke
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 342 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic Blood Pressure great than or equal to 180 or diastolic blood pressure great than or equal to 110 (from visit)
Frequency: 55 affected / 342 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic blood pressure less than 90 or diastolic blood pressure less than 90 (from visit)
Frequency: 19 affected / 342 at risk

Adverse event: Self reported dizziness upon standing or fainting
Serious: no
Organ System: General disorders
Frequency: 22 affected / 342 at risk

Adverse event: Self reported falls that did not result in an ED visit
Serious: no
Organ System: General disorders
Frequency: 47 affected / 342 at risk

Adverse event: Any ED Visit
Serious: yes
Organ System: General disorders
Frequency: 81 affected / 283 at risk

Adverse event: Any hospitalization
Serious: yes
Organ System: General disorders
Frequency: 44 affected / 283 at risk

Adverse event: Self reported falls with Ed visit
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 283 at risk

Adverse event: Self reported stroke
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 283 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic Blood Pressure great than or equal to 180 or diastolic blood pressure great than or equal to 110 (from visit)
Frequency: 54 affected / 283 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic blood pressure less than 90 or diastolic blood pressure less than 90 (from visit)
Frequency: 9 affected / 283 at risk

Adverse event: Self reported dizziness upon standing or fainting
Serious: no
Organ System: General disorders
Frequency: 29 affected / 283 at risk

Adverse event: Self reported falls that did not result in an ED visit
Serious: no
Organ System: General disorders
Frequency: 43 affected / 283 at risk

Adverse event: Any ED Visit
Serious: yes
Organ System: General disorders
Frequency: 105 affected / 330 at risk

Adverse event: Any hospitalization
Serious: yes
Organ System: General disorders
Frequency: 52 affected / 330 at risk

Adverse event: Self reported falls with Ed visit
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 330 at risk

Adverse event: Self reported stroke
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 330 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic Blood Pressure great than or equal to 180 or diastolic blood pressure great than or equal to 110 (from visit)
Frequency: 37 affected / 330 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic blood pressure less than 90 or diastolic blood pressure less than 90 (from visit)
Frequency: 19 affected / 330 at risk

Adverse event: Self reported dizziness upon standing or fainting
Serious: no
Organ System: General disorders
Frequency: 31 affected / 330 at risk

Adverse event: Self reported falls that did not result in an ED visit
Serious: no
Organ System: General disorders
Frequency: 40 affected / 330 at risk

Adverse event: Any ED Visit
Serious: yes
Organ System: General disorders
Frequency: 85 affected / 285 at risk

Adverse event: Any hospitalization
Serious: yes
Organ System: General disorders
Frequency: 41 affected / 285 at risk

Adverse event: Self reported falls with Ed visit
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 285 at risk

Adverse event: Self reported stroke
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 285 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic Blood Pressure great than or equal to 180 or diastolic blood pressure great than or equal to 110 (from visit)
Frequency: 44 affected / 285 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Systolic blood pressure less than 90 or diastolic blood pressure less than 90 (from visit)
Frequency: 18 affected / 285 at risk

Adverse event: Self reported dizziness upon standing or fainting
Serious: no
Organ System: General disorders
Frequency: 26 affected / 285 at risk

Adverse event: Self reported falls that did not result in an ED visit
Serious: no
Organ System: General disorders
Frequency: 20 affected / 285 at risk