Study: NCT00926588

Adverse event: Cardiac hospitalization
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac hospitalization unrelated to participation in study.
Frequency: 5 affected / 124 at risk

Adverse event: Hospitalization due to infection
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalization not related to participation in study.
Frequency: 2 affected / 124 at risk

Adverse event: Hospitalization due to renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Hospitalization unrelated to participation in study.
Frequency: 1 affected / 124 at risk

Adverse event: Hospitalization due to knee replacement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hospitalization and surgery unrelated to participation in study.
Frequency: 3 affected / 124 at risk

Adverse event: Hospitalization due to motor vehicle accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospitalization unrelated to participation in study.
Frequency: 1 affected / 124 at risk

Adverse event: Bladder repair surgery and hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Notes: Surgery and hospitalization unrelated to participation in study.
Frequency: 1 affected / 124 at risk

Adverse event: Hospitalization due to removal of fibroids
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalization unrelated to participation in study.
Frequency: 1 affected / 124 at risk

Adverse event: Hospitalization due to planned hysterectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Surgery and hospitalization unrelated to participation in study.
Frequency: 1 affected / 124 at risk

Adverse event: Hospitalization due to appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization unrelated to participation in study.
Frequency: 1 affected / 124 at risk

Adverse event: Hospitalization due to esophagogastrectomy
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization unrelated to participation in study.
Frequency: 1 affected / 124 at risk

Adverse event: Hospitalization due to hypotension, headache, muscle ache
Serious: yes
Organ System: General disorders
Notes: Hospitalization unrelated to participation in study.
Frequency: 1 affected / 124 at risk

Adverse event: Hospitalization due to coronary artery bypass surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization unrelated to participation in research study.
Frequency: 2 affected / 124 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death unrelated to participation in study.
Frequency: 1 affected / 124 at risk

Adverse event: Hospitalization due to sepsis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospitalization unrelated to participation in research
Frequency: 1 affected / 124 at risk

Adverse event: Pneumonia hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization unrelated to research study.
Frequency: 1 affected / 126 at risk

Adverse event: Gall bladder removal surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Surgery unrelated to participation in study.
Frequency: 1 affected / 126 at risk

Adverse event: Cardiac hospitalization
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac hospitalization unrelated to participation in study.
Frequency: 1 affected / 126 at risk

Adverse event: TIA hospitalization
Serious: yes
Organ System: Nervous system disorders
Notes: Hospitalization unrelated to participation in study.
Frequency: 1 affected / 126 at risk

Adverse event: Stress center hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization unrelated to participation in study.
Frequency: 1 affected / 126 at risk

Adverse event: Sinus surgery hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Notes: Subject admitted to hospital for planned sinus surgery.
Frequency: 1 affected / 126 at risk

Adverse event: Mental Health referral due to suicidality
Serious: yes
Organ System: Psychiatric disorders
Notes: Unrelated to participation in study.
Frequency: 1 affected / 126 at risk

Adverse event: Subject suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject revealed suicidal ideation during screening. Unrelated to participation in research study.
Frequency: 1 affected / 126 at risk