Study: NCT01155050

Adverse event: Hospitalization and/or emergency department visit
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalization for any reason or an emergency department visit for any reason
Frequency: 14 affected / 50 at risk

Adverse event: mild or moderate unanticipated health events
Serious: no
Organ System: General disorders
Notes: Includes (1) unanticipated outpatient clinic visits and (2) significant changes in reported health status not resulting in emergency department visits or hospitalization and deemed unrelated or unlikely to be related to the study interventions.
Frequency: 1 affected / 50 at risk

Adverse event: Hospitalization and/or emergency department visit
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalization for any reason or an emergency department visit for any reason
Frequency: 18 affected / 51 at risk

Adverse event: unexpected outpatient clinic visit
Serious: yes
Organ System: General disorders
Notes: Unexpected/unplanned outpatient clinic visits for emergent conditions.
Frequency: 2 affected / 51 at risk

Adverse event: mild or moderate unanticipated health events
Serious: no
Organ System: General disorders
Notes: Includes (1) unanticipated outpatient clinic visits and (2) significant changes in reported health status not resulting in emergency department visits or hospitalization and deemed unrelated or unlikely to be related to the study interventions.
Frequency: 3 affected / 51 at risk

Adverse event: Hospitalization and/or emergency department visit
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalization for any reason or an emergency department visit for any reason
Frequency: 19 affected / 52 at risk

Adverse event: unexpected outpatient clinic visit
Serious: yes
Organ System: General disorders
Notes: Unexpected/unplanned outpatient clinic visits for emergent conditions.
Frequency: 3 affected / 52 at risk

Adverse event: mild or moderate unanticipated health events
Serious: no
Organ System: General disorders
Notes: Includes (1) unanticipated outpatient clinic visits and (2) significant changes in reported health status not resulting in emergency department visits or hospitalization and deemed unrelated or unlikely to be related to the study interventions.
Frequency: 6 affected / 52 at risk

Adverse event: Hospitalization and/or emergency department visit
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalization for any reason or an emergency department visit for any reason
Frequency: 19 affected / 49 at risk

Adverse event: unexpected outpatient clinic visit
Serious: yes
Organ System: General disorders
Notes: Unexpected/unplanned outpatient clinic visits for emergent conditions.
Frequency: 1 affected / 49 at risk

Adverse event: mild or moderate unanticipated health events
Serious: no
Organ System: General disorders
Notes: Includes (1) unanticipated outpatient clinic visits and (2) significant changes in reported health status not resulting in emergency department visits or hospitalization and deemed unrelated or unlikely to be related to the study interventions.
Frequency: 3 affected / 49 at risk