Extension Study Investigating the Long-Term Safety of Deg... | NCT00117286

Label	Type	Description	Intervention Names
Degarelix (60 mg to 160 mg)	Experimental	Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Drug: Degarelix
Degarelix (80 mg to 160 mg)	Experimental	Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	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	This outcome measure 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
Urology Centers of Alabama		Homewood	Alabama	35209	United States
Advanced Urology Medical Center

ID	Title	Description
FG000	Degarelix (60 mg to 160 mg)	Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
FG001	Degarelix (80 mg to 160 mg)

ID	Title	Description
BG000	Degarelix (60 mg to 160 mg)	Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
BG001	Degarelix (80 mg to 160 mg)	Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00030 BG00127 BG00257

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Safety analysis set

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00076.0± 6.63 BG00174.1± 8.85 BG00275.1± 7.75

Sex: Female, Male

Safety analysis set

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Race (NIH/OMB)

Safety analysis set

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Body weight

Safety analysis set

Mean

Standard Deviation

kilogram

Title

Denominators

Categories

Title	Measurements
	BG00079.0± 11.4 BG00181.3± 13.3 BG002

Body mass index

Safety analysis set

Mean

Standard Deviation

kilogram per square meter

Title

Denominators

Categories

Title	Measurements
	BG00026.5± 3.64 BG00126.6± 4.63 BG002

Curative Intent

Safety analysis set. A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00011 BG00111 BG002

Gleason Score

Safety analysis set. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.

Number

participants

Title

Denominators

Categories

2-4

Title	Measurements
	BG0002 BG001

Stage of Prostate Cancer

Safety analysis set. Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.

Number

participants

Title

Denominators

Categories

Localized

Title	Measurements
	BG00014 BG001

Time since Prostate Cancer Diagnosis

Safety analysis set

Mean

Standard Deviation

days

Title

Denominators

Categories

Title	Measurements
	BG0001253± 1565 BG0011349± 1625 BG002

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

This outcome measure 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 CS14) and the extension study FE200486 CS14A.

Posted

Number

participants

5 years

ID	Title	Description
OG000	Degarelix (60 mg to 160 mg)	Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
OG001	Degarelix (80 mg to 160 mg)	Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.

Units	Counts
Participants	OG00030 OG00127

Title

Denominators

Categories

Diastolic blood pressure <=50 and decrease >=15

Title	Measurements
	OG0009 OG0014

Diastolic blood pressure >=105 and increase >=15

Title	Measurements
	OG000

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 CS14) and the extension study FE200486 CS14A.

Posted

Number

participants

5 years

ID	Title	Description
OG000	Degarelix (60 mg to 160 mg)	Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
OG001	Degarelix (80 mg to 160 mg)	Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Coronary artery disease	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Asthenia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
General physcial health deterioration	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected27 at risk
Appendiceal abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Appendicitis perforated	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Metastasis to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 at risk
Urinary retention	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events1 affected30 at risk EG0012 events1 affected27 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Aortic aneurysm	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected27 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected27 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	EG0004 events4 affected30 at risk EG0012 events2 affected27 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected27 at risk
Myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected27 at risk
Bundle branch block left	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected27 at risk
Cataract	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected30 at risk EG0014 events4 affected27 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0015 events5 affected27 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events5 affected30 at risk EG0012 events2 affected27 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0013 events3 affected27 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected27 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected30 at risk EG0010 events0 affected27 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Fatigue	General disorders	MedDRA (12.0)	Systematic Assessment	EG00011 events8 affected30 at risk EG0019 events5 affected27 at risk
Injection site pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG00018 events7 affected30 at risk EG00119 events6 affected27 at risk
Injection site nodule	General disorders	MedDRA (12.0)	Systematic Assessment	EG00016 events7 affected30 at risk EG00114 events5 affected27 at risk
Injection site erythema	General disorders	MedDRA (12.0)	Systematic Assessment	EG00018 events3 affected30 at risk EG00114 events5 affected27 at risk
Chills	General disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events2 affected30 at risk EG0018 events5 affected27 at risk
Injection site induration	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0016 events4 affected27 at risk
Oedema peripheral	General disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0015 events2 affected27 at risk
Injection site haematoma	General disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0014 events1 affected27 at risk
Injection site mass	General disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events1 affected30 at risk EG0012 events2 affected27 at risk
Injection site reaction	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0013 events2 affected27 at risk
Pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected30 at risk EG0012 events1 affected27 at risk
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0013 events2 affected27 at risk
Asthenia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected27 at risk
Chest discomfort	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0013 events2 affected27 at risk
Injection site warmth	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected27 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0009 events5 affected30 at risk EG0018 events6 affected27 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected30 at risk EG0017 events6 affected27 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected30 at risk EG0011 events1 affected27 at risk
Bronchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected27 at risk
Tooth abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected27 at risk
Influenza	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected30 at risk EG0010 events0 affected27 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected27 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected27 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Weight increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected30 at risk EG0017 events7 affected27 at risk
Prostatic specific antigen increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected30 at risk EG0011 events1 affected27 at risk
Weight decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected30 at risk EG0012 events2 affected27 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected30 at risk EG0011 events1 affected27 at risk
Haemoglobin decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected27 at risk
Blood creatinine increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Cardiac murmur	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected27 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected30 at risk EG0012 events2 affected27 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected30 at risk EG0012 events2 affected27 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected27 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected27 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected30 at risk EG0015 events5 affected27 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0016 events6 affected27 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0014 events4 affected27 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0013 events3 affected27 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected27 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected27 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0013 events2 affected27 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events4 affected30 at risk EG0016 events5 affected27 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0013 events2 affected27 at risk
Insomnia	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected30 at risk EG0013 events3 affected27 at risk
Anxiety	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected27 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected30 at risk EG0013 events3 affected27 at risk
Dysuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0015 events4 affected27 at risk
Micturition urgency	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0014 events3 affected27 at risk
Nocturia	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0018 events5 affected27 at risk
Haematuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0012 events2 affected27 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected27 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected30 at risk EG0010 events0 affected27 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0014 events2 affected27 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected27 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0012 events2 affected27 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected30 at risk EG0012 events2 affected27 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events4 affected30 at risk EG0013 events1 affected27 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0013 events3 affected27 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events5 affected30 at risk EG0016 events5 affected27 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0012 events2 affected27 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected27 at risk
Hot flush	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG00015 events12 affected30 at risk EG00119 events15 affected27 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected30 at risk EG0016 events4 affected27 at risk
Hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0014 events4 affected27 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	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Degarelix (60 mg to 160 mg)	Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.			11	30	29	30
EG001	Degarelix (80 mg to 160 mg)	Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.			7	27	26	27