Study: NCT00112151

Adverse event: Total serious cardiovascular adverse events
Serious: yes
Organ System: Cardiac disorders
Notes: Includes acute coronary syndrome, arrhythmia, aortic aneurysm, syncope/presyncope
Frequency: 10 affected / 47 at risk

Adverse event: Other noncardiovascular serious adverse events
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 47 at risk

Adverse event: Persistently elevated HCT >= 54%
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Polycythemia or persistent elevated hematocrit \>= 54%
Frequency: 3 affected / 47 at risk

Adverse event: Persistently elevated PSA
Serious: no
Organ System: Renal and urinary disorders
Notes: Persistent elevated PSA representing an increase of \>=0.75 ng/mL over baseline
Frequency: 9 affected / 47 at risk

Adverse event: Elevated AUA
Serious: no
Organ System: Renal and urinary disorders
Notes: American Urological Association (AUA) BPH Symptom Score Index \>= 20
Frequency: 2 affected / 47 at risk

Adverse event: Other nonserious adverse events
Serious: no
Organ System: General disorders
Notes: Other nonserious adverse events
Frequency: 9 affected / 47 at risk

Adverse event: Total serious cardiovascular adverse events
Serious: yes
Organ System: Cardiac disorders
Notes: Includes acute coronary syndrome, arrhythmia, aortic aneurysm, syncope/presyncope
Frequency: 2 affected / 47 at risk

Adverse event: Other noncardiovascular serious adverse events
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 47 at risk

Adverse event: Persistently elevated HCT >= 54%
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Polycythemia or persistent elevated hematocrit \>= 54%
Frequency: 2 affected / 47 at risk

Adverse event: Persistently elevated PSA
Serious: no
Organ System: Renal and urinary disorders
Notes: Persistent elevated PSA representing an increase of \>=0.75 ng/mL over baseline
Frequency: 5 affected / 47 at risk

Adverse event: Elevated AUA
Serious: no
Organ System: Renal and urinary disorders
Notes: American Urological Association (AUA) BPH Symptom Score Index \>= 20
Frequency: 1 affected / 47 at risk

Adverse event: Other nonserious adverse events
Serious: no
Organ System: General disorders
Notes: Other nonserious adverse events
Frequency: 6 affected / 47 at risk

Adverse event: Total serious cardiovascular adverse events
Serious: yes
Organ System: Cardiac disorders
Notes: Includes acute coronary syndrome, arrhythmia, aortic aneurysm, syncope/presyncope
Frequency: 1 affected / 49 at risk

Adverse event: Other noncardiovascular serious adverse events
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 49 at risk

Adverse event: Persistently elevated HCT >= 54%
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Polycythemia or persistent elevated hematocrit \>= 54%
Frequency: 11 affected / 49 at risk

Adverse event: Persistently elevated PSA
Serious: no
Organ System: Renal and urinary disorders
Notes: Persistent elevated PSA representing an increase of \>=0.75 ng/mL over baseline
Frequency: 7 affected / 49 at risk

Adverse event: Other nonserious adverse events
Serious: no
Organ System: General disorders
Notes: Other nonserious adverse events
Frequency: 7 affected / 49 at risk