A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events

The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Incidence Rate of AESI: Decreased Bone Density

IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)

IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE. Glucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Change in Hepatic Enzymes

Change from baseline in hepatic enzyme levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase \[ALP\]) are presented.

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Change in Hepatic Enzymes

Change from baseline in hepatic enzyme level (bilirubin) is presented.

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Change in Serum Glucose

Change from baseline in serum glucose are presented.

Time frame: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)