An Extension Study Evaluating the Long-Term Safety and To... | NCT00215683

Label	Type	Description	Intervention Names
Degarelix 80 mg	Experimental	Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).	Drug: Degarelix
Degarelix 120 mg	Experimental	Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).	Drug: Degarelix
Degarelix 160 mg	Experimental	Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).	Drug: Degarelix

Name	Type	Description	Arm Group Labels	Other Names
Degarelix	Drug	Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.

Measure	Description	Time Frame
Participants With Markedly Abnormal Change in Vital Signs and Body Weight	Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.	5 years
Liver Function Tests	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.	5 years

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UCL Saint Luc		Brussels			Belgium
UZ Gent

ID	Title	Description
FG000	Degarelix 80 mg	Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
FG001	Degarelix 120 mg

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.

Posted

Number

participants

5 years

ID	Title	Description
OG000	Degarelix 80 mg	Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
OG001	Degarelix 120 mg	Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
OG002	Degarelix 160 mg	Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.

Units	Counts
Participants	OG00045 OG00148 OG00244

Title

Denominators

Categories

Diastolic blood pressure <=50 and decrease >=15

Title	Measurements
	OG0003 OG0015 OG00210

Diastolic blood pressure >=105 and increase >=15

Primary

Liver Function Tests

The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.

The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.

Posted

Number

participants

5 years

ID	Title	Description
OG000	Degarelix 80 mg	Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
OG001	Degarelix 120 mg	Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
OG002	Degarelix 160 mg	Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Angina pectoris	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00010 events1 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Atrioventricular block	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Cardiac failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Corneal defect	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Neurotrophic keratopathy	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Ulcerative keratitis	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0028 events1 affected44 at risk
Ileus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0012 events2 affected48 at risk EG0020 events0 affected44 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Subileus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Disease progression	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Oedema peripheral	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Appendicitis perforated	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0015 events4 affected48 at risk EG0021 events1 affected44 at risk
Bronchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Bronchopneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Gastroenteritis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Angiogram	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Blood potassium increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Intravertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0012 events1 affected48 at risk EG0020 events0 affected44 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events3 affected48 at risk EG0021 events1 affected44 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Acoustic neuroma	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Benign colonic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Carcinoma in situ of eye	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Renal cell carcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Cerebovascular accident	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0012 events2 affected48 at risk EG0021 events1 affected44 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Aphasia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Cerebral circulatory failure	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Cerebral infarction	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Monoplegia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0022 events1 affected44 at risk
Neuralgia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Paraparesis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0012 events1 affected48 at risk EG0020 events0 affected44 at risk
Post polio syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Sciatica	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Spinal cord compression	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Confusional state	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Depression	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Urinary retention	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected48 at risk EG0022 events2 affected44 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events1 affected48 at risk EG0020 events0 affected44 at risk
Anuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Haematuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0020 events0 affected44 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0022 events1 affected44 at risk
Femoral artery occlusion	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Lymphoedema	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0020 events0 affected44 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events3 affected45 at risk EG0011 events1 affected48 at risk EG0022 events2 affected44 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0015 events4 affected48 at risk EG0021 events1 affected44 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0013 events3 affected48 at risk EG0020 events0 affected44 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0012 events2 affected48 at risk EG0022 events2 affected44 at risk
Bradycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0022 events2 affected44 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0014 events4 affected48 at risk EG0020 events0 affected44 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0023 events2 affected44 at risk
Cataract	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events2 affected45 at risk EG0014 events2 affected48 at risk EG0024 events3 affected44 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0009 events7 affected45 at risk EG0013 events2 affected48 at risk EG0022 events2 affected44 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events3 affected45 at risk EG0015 events5 affected48 at risk EG0027 events6 affected44 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events5 affected45 at risk EG0012 events1 affected48 at risk EG0024 events4 affected44 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0011 events1 affected48 at risk EG0023 events2 affected44 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events3 affected48 at risk EG0020 events0 affected44 at risk
Injection site pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG00028 events6 affected45 at risk EG00122 events11 affected48 at risk EG00248 events13 affected44 at risk
Fatigue	General disorders	MedDRA (12.0)	Systematic Assessment	EG0008 events6 affected45 at risk EG0017 events3 affected48 at risk EG0029 events6 affected44 at risk
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events6 affected45 at risk EG0016 events3 affected48 at risk EG00211 events6 affected44 at risk
Injection site erythema	General disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected45 at risk EG0014 events2 affected48 at risk EG00215 events9 affected44 at risk
Injection site nodule	General disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events3 affected45 at risk EG0016 events5 affected48 at risk EG0025 events5 affected44 at risk
Injection site swelling	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0019 events4 affected48 at risk EG00213 events6 affected44 at risk
Oedema peripheral	General disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events4 affected45 at risk EG0016 events4 affected48 at risk EG0024 events2 affected44 at risk
Asthenia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected45 at risk EG0012 events2 affected48 at risk EG0022 events2 affected44 at risk
Injection site inflammation	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events3 affected48 at risk EG0024 events4 affected44 at risk
Chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected48 at risk EG0022 events2 affected44 at risk
Hyperthermia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected48 at risk EG0022 events2 affected44 at risk
Injection site haematoma	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0022 events2 affected44 at risk
Injection site reaction	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0024 events3 affected44 at risk
Influenza	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0008 events6 affected45 at risk EG00115 events9 affected48 at risk EG0029 events8 affected44 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0006 events4 affected45 at risk EG00111 events6 affected48 at risk EG0024 events4 affected44 at risk
Bronchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected45 at risk EG0012 events2 affected48 at risk EG0028 events5 affected44 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0007 events2 affected45 at risk EG0014 events2 affected48 at risk EG0028 events4 affected44 at risk
Pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0013 events2 affected48 at risk EG0023 events3 affected44 at risk
Gastroenteritis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0013 events3 affected48 at risk EG0022 events2 affected44 at risk
Rhinitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0025 events4 affected44 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0015 events4 affected48 at risk EG0021 events1 affected44 at risk
Prostatic specific antigen increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG00012 events11 affected45 at risk EG00110 events8 affected48 at risk EG0029 events7 affected44 at risk
Weight increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected45 at risk EG00110 events9 affected48 at risk EG0027 events7 affected44 at risk
Weight decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0019 events7 affected48 at risk EG0028 events8 affected44 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events3 affected48 at risk EG0027 events5 affected44 at risk
Blood urea increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0004 events2 affected45 at risk EG0012 events2 affected48 at risk EG0025 events5 affected44 at risk
Alanine aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0016 events3 affected48 at risk EG0025 events3 affected44 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0013 events2 affected48 at risk EG0025 events3 affected44 at risk
Blood creatinine increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected45 at risk EG0011 events1 affected48 at risk EG0023 events3 affected44 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0014 events1 affected48 at risk EG0023 events2 affected44 at risk
Platelet count decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0023 events2 affected44 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected48 at risk EG0022 events2 affected44 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected48 at risk EG0022 events2 affected44 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0009 events3 affected45 at risk EG0018 events6 affected48 at risk EG00224 events9 affected44 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0009 events6 affected45 at risk EG0017 events7 affected48 at risk EG0025 events5 affected44 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events5 affected45 at risk EG0014 events3 affected48 at risk EG0026 events3 affected44 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events3 affected45 at risk EG0012 events2 affected48 at risk EG0023 events3 affected44 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events5 affected45 at risk EG0011 events1 affected48 at risk EG0021 events1 affected44 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0011 events1 affected48 at risk EG0025 events3 affected44 at risk
Mylagia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0025 events4 affected44 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events1 affected45 at risk EG0011 events1 affected48 at risk EG0022 events2 affected44 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected45 at risk EG0012 events1 affected48 at risk EG0020 events0 affected44 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0011 events1 affected48 at risk EG0022 events2 affected44 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0022 events2 affected44 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0018 events5 affected48 at risk EG0023 events3 affected44 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0010 events0 affected48 at risk EG0024 events2 affected44 at risk
Insomnia	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0014 events4 affected48 at risk EG0025 events4 affected44 at risk
Anxiety	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected48 at risk EG0023 events3 affected44 at risk
Depression	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected45 at risk EG0010 events0 affected48 at risk EG0023 events3 affected44 at risk
Haematuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected45 at risk EG0010 events0 affected48 at risk EG0027 events5 affected44 at risk
Nocturia	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0011 events1 affected48 at risk EG0022 events1 affected44 at risk
Urinary retention	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events3 affected48 at risk EG0021 events1 affected44 at risk
Dysuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events3 affected48 at risk EG0020 events0 affected44 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected48 at risk EG0022 events2 affected44 at risk
Renal collic	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected48 at risk EG0022 events2 affected44 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected45 at risk EG0011 events1 affected48 at risk EG0023 events3 affected44 at risk
Prostatism	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected45 at risk EG0010 events0 affected48 at risk EG0022 events2 affected44 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0010 events0 affected48 at risk EG0021 events1 affected44 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected45 at risk EG0013 events2 affected48 at risk EG00211 events8 affected44 at risk
Dyspnoea	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0014 events3 affected48 at risk EG0024 events3 affected44 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events1 affected45 at risk EG0011 events1 affected48 at risk EG0022 events2 affected44 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0012 events2 affected48 at risk EG0022 events2 affected44 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0023 events2 affected44 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0012 events2 affected48 at risk EG0029 events3 affected44 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected45 at risk EG0011 events1 affected48 at risk EG0021 events1 affected44 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events1 affected45 at risk EG0010 events0 affected48 at risk EG0023 events2 affected44 at risk
Hot flush	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG00027 events19 affected45 at risk EG00118 events18 affected48 at risk EG00220 events17 affected44 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected45 at risk EG0013 events3 affected48 at risk EG0024 events3 affected44 at risk
Orthostatic hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected48 at risk EG0022 events2 affected44 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events3 affected48 at risk EG0023 events3 affected44 at risk

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Title	Description
BG000	Degarelix 80 mg	Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
BG001	Degarelix 120 mg	Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
BG002	Degarelix 160 mg	Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Degarelix 80 mg	Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	19	45	35	45
EG001	Degarelix 120 mg	Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	20	48	41	48
EG002	Degarelix 160 mg	Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	10	44	38	44