A Parallel Group Comparison of the Efficacy and Safety of... | NCT00116779

Label	Type	Description	Intervention Names
Degarelix 60mg	Experimental	Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.	Drug: Degarelix
Degarelix 80mg	Experimental	Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.	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. Maintenance dose given in twelve 28-day cycles.	Degarelix 60mg

Measure	Description	Time Frame
Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364	Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364	Day 28 to Day 364
Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28	Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.	Day 28 - Day 364

Measure	Description	Time Frame
Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.	Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.	Day 3
Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study.

Has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention.
Male patient aged 18 years or over.
Has a baseline testosterone above the lower limit of normal range.
Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2.
Has a PSA value of greater than or equal to 2ng/mL.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered into the study.

Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens). However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit.
Currently or recently (within the last 12 weeks preceding the Screening Visit) under treatment with any other drug modifying testosterone level or function.
Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit.
Has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or Quincke's Edema.
Has hypersensitivity towards any component of the investigational products (degarelix or mannitol).
Has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
Has elevated serum ALT level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the Screening Visit.
Has known or suspect hepatic disease of any sort. Patients with liver disease are not to be enrolled in this study.
Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results.
Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator.
Has a mental incapacity or language barriers precluding adequate understanding or cooperation.
Has received an investigational drug within the last 12 weeks preceding Screening Visit.
Has previously participated in any degarelix study

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
Alaska Clinical Research Center, LLC

PubMed Identifier	Type	Citation	Retractions
18801505	Result	Gittelman M, Pommerville PJ, Persson BE, Jensen JK, Olesen TK; Degarelix Study Group. A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America. J Urol. 2008 Nov;180(5):1986-92. doi: 10.1016/j.juro.2008.07.033. Epub 2008 Sep 17.

ID	Title	Description
FG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
FG001	Degarelix 80mg

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00074.8± 8.73 BG00174.9± 9.55 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Curative Intent

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

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG00041 BG00140 BG002

Participant Counts by Gleason Score

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
	BG0003 BG001

The Number of Participants at Each Stage of Prostate Cancer

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
	BG00031 BG001

Body Mass Index

Body mass index is a measure of body fat based on height and weight.

Mean

Full Range

kilogram per square meter

Title

Denominators

Categories

Title	Measurements
	BG00027.3± 4.1(19.1 to 39.2) BG00126.7± 3.98

Days Since Diagnosis of Prostate Cancer

The number of days passed since a diagnosis of prostate cancer was made for each participant.

Mean

Standard Deviation

days

Title

Denominators

Categories

Title	Measurements
	BG0001213± 1597 BG0011256± 1550

Serum Prostate-Specific Antigen

Prostate-specific antigen (PSA) is a protein produced by the cells of the prostate gland. The PSA test measures the level of PSA in the blood. High PSA levels have a postive corrolation to prostate cancer.

Median

Full Range

nanograms/milliliter

Title

Denominators

Categories

Title	Measurements
	BG00012.7(2.7 to 759) BG001

Serum Testosterone level

Testosterone is a steroid hormone from the androgen group, and the principal male sex hormone. This test measures the amount of testosterone in the blood. Androgen deprivation is used to manage prostate cancer.

Median

Full Range

nanograms/milliliter

Title

Denominators

Categories

Title	Measurements
	BG0004.1(1.51 to 11) BG001

Weight

Mean of Participants Weight in Kilograms

Mean

Standard Deviation

Kilograms

Title

Denominators

Categories

Title	Measurements
	BG00083± 14.6 BG00181.2± 12.7 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

Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364

Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364

ITT population of patients who completed the study and had testosterone <=0.5 nanogram per milliliter at Day 28.

Posted

Number

participants

Day 28 to Day 364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG00049 OG00153

Title

Denominators

Categories

Title	Measurements
	OG00042(73 to 94) OG00141(64 to 88)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000						Percentage of participants	86				95	73	94			The 95% confidence interval was calculated by Clopper-Pearson method.	No	Superiority or Other
OG001

Secondary

Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.

Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.

ITT population

Posted

Number

participants

Day 3

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Primary

Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28

Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.

ITT population of participants who completed the study and had a testosterone level of <=0.5 nanogram per milliliter at Day 28.

Posted

Number

participants

Day 28 - Day 364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants

Secondary

Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen

Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.

ITT population

Posted

Median

Full Range

days

Day 0 (post dose) to Day 364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Secondary

Days to Prostate-Specific Antigen Progression

Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.

ITT population. 5 patients in the 60 mg group and 4 patients in the 80 mg group had PSA progression.

Posted

Median

Full Range

days

Day 0 (post dose) to Day 364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Secondary

Median Di-Hydrotestosterone Levels At Various Study Timepoints

Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14

ITT population

Posted

Median

Full Range

picogram / milliliter

Baseline, Days 1, 3, 7, 14

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Secondary

Median Prostate-Specific Antigen Values at Various Study Timepoints

Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.

ITT population

Posted

Median

Full Range

nanogram / milliliter

Baseline, Days 3, 14, 28, 84, 364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Secondary

Median Luteinizing Hormone Levels at Various Study Timeframes

Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.

ITT population

Posted

Median

Full Range

international units / liter

Baseline, Days 1, 3, 7, 14

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Secondary

Median Testosterone Levels at Various Days During the Study

Testosterone levels at baseline and days 1, 3, 7, 14 and 364

ITT population

Posted

Median

Full Range

nanograms / milliliter

Baseline, Days 1,3,7,14,364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Abnormal Alanine Aminotransferase Values

Participants whose alanine aminotransferase values were at levels above the normal range.

ITT population

Posted

Number

participants

Day 1 through day 364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Abnormal Aspartate Aminotransferase Values

Participants with aspartate aminotransferase values that were above the normal range.

ITT population

Posted

Number

participants

Day 1 - 364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Abnormal Total Bilirubin Values

Participants with abnormal total bilirubin values

ITT population

Posted

Number

participants

Day 1 - 364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants	OG000

Secondary

Participants With Markedly Abnormal Changes in Vital Signs or Body Weight

Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.

ITT population. Diastolic blood pressure n=63,63 Pulse n=63,60 Systolic blood pressure n=63,64 Weight n=55,61

Posted

Number

participants

Day 364

ID	Title	Description
OG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
OG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial infarction	Cardiac disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0011 events1 affected64 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 7.0	Systematic Assessment	EG0000 events0 affected63 at risk EG0011 events1 affected64 at risk
Coronary artery disease	Cardiac disorders	MedDRA 7.0	Systematic Assessment	EG0000 events0 affected63 at risk EG0011 events1 affected64 at risk
Constipation	Gastrointestinal disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA 7.0	Systematic Assessment	EG0000 events0 affected63 at risk EG0011 events1 affected64 at risk
Injection site urticaria	General disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 7.0	Systematic Assessment	EG0000 events0 affected63 at risk EG0011 events1 affected64 at risk
Pneumonia	Infections and infestations	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0011 events1 affected64 at risk
Orchitis	Infections and infestations	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Perirectal abscess	Infections and infestations	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 7.0	Systematic Assessment	EG0000 events0 affected63 at risk EG0012 events1 affected64 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected64 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 7.0	Systematic Assessment	EG0003 events3 affected63 at risk EG0012 events2 affected64 at risk
Constipation	Gastrointestinal disorders	MedDRA 7.0	Systematic Assessment	EG0004 events4 affected63 at risk EG0014 events4 affected64 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 7.0	Systematic Assessment	EG0003 events3 affected63 at risk EG0012 events2 affected64 at risk
Nausea	Gastrointestinal disorders	MedDRA 7.0	Systematic Assessment	EG0004 events3 affected63 at risk EG0012 events2 affected64 at risk
Fatigue	General disorders	MedDRA 7.0	Systematic Assessment	EG00012 events10 affected63 at risk EG00118 events15 affected64 at risk
Injection site pain	General disorders	MedDRA 7.0	Systematic Assessment	EG0005 events4 affected63 at risk EG0019 events5 affected64 at risk
Asthenia	General disorders	MedDRA 7.0	Systematic Assessment	EG0002 events2 affected63 at risk EG0015 events4 affected64 at risk
Nasopharyngitis	Infections and infestations	MedDRA 7.0	Systematic Assessment	EG00010 events7 affected63 at risk EG0017 events7 affected64 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0016 events5 affected64 at risk
Urinary tract infection	Infections and infestations	MedDRA 7.0	Systematic Assessment	EG0004 events3 affected63 at risk EG0013 events2 affected64 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0013 events3 affected64 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 7.0	Systematic Assessment	EG0003 events3 affected63 at risk EG0010 events0 affected64 at risk
Weight increased	Investigations	MedDRA 7.0	Systematic Assessment	EG0004 events4 affected63 at risk EG0014 events4 affected64 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 7.0	Systematic Assessment	EG0002 events1 affected63 at risk EG0013 events3 affected64 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 7.0	Systematic Assessment	EG0004 events3 affected63 at risk EG0014 events4 affected64 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 7.0	Systematic Assessment	EG0002 events2 affected63 at risk EG0015 events5 affected64 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 7.0	Systematic Assessment	EG0000 events0 affected63 at risk EG0014 events3 affected64 at risk
Dizziness	Nervous system disorders	MedDRA 7.0	Systematic Assessment	EG00011 events7 affected63 at risk EG0017 events6 affected64 at risk
Insomnia	Psychiatric disorders	MedDRA 7.0	Systematic Assessment	EG0002 events2 affected63 at risk EG0016 events5 affected64 at risk
Anxiety	Psychiatric disorders	MedDRA 7.0	Systematic Assessment	EG0003 events3 affected63 at risk EG0012 events1 affected64 at risk
Nocturia	Renal and urinary disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0017 events7 affected64 at risk
Dysuria	Renal and urinary disorders	MedDRA 7.0	Systematic Assessment	EG0003 events3 affected63 at risk EG0014 events3 affected64 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 7.0	Systematic Assessment	EG0001 events1 affected63 at risk EG0015 events4 affected64 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 7.0	Systematic Assessment	EG0004 events4 affected63 at risk EG0011 events1 affected64 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 7.0	Systematic Assessment	EG0004 events4 affected63 at risk EG0016 events6 affected64 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 7.0	Systematic Assessment	EG0003 events3 affected63 at risk EG0014 events3 affected64 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 7.0	Systematic Assessment	EG0004 events3 affected63 at risk EG0013 events3 affected64 at risk
Hot flush	Vascular disorders	MedDRA 7.0	Systematic Assessment	EG00026 events24 affected63 at risk EG00137 events31 affected64 at risk
Hypertension	Vascular disorders	MedDRA 7.0	Systematic Assessment	EG0004 events4 affected63 at risk EG0014 events4 affected64 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 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
BG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Degarelix 60mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.			9		55
EG001	Degarelix 80mg	Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.			6		52