The Efficacy and Safety of Degarelix One Month Dosing Reg... | NCT00295750

Label	Type	Description	Intervention Names
degarelix 240/160 mg	Experimental	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.	Drug: Degarelix
degarelix 240/80 mg	Experimental	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.	Drug: Degarelix
Leuprolide 7.5 mg	Active Comparator	Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.	Drug: Leuprolide 7.5 mg

Name	Type	Description	Arm Group Labels	Other Names
Degarelix	Drug	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.	degarelix 240/160 mg

Measure	Description	Time Frame
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364	Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.	12 months

Measure	Description	Time Frame
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment	A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).	2 weeks
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3

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
19035858	Result	Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
34350976

ID	Title	Description
FG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
FG001	Degarelix 240/80 mg

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Intent-to-treat (ITT) population.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age Continuous

ITT population.

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00072± 8.47(50 to 88) BG00172± 8.12(51 to 89)

Sex: Female, Male

ITT population.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Race (NIH/OMB)

ITT population

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00022 BG00118 BG002

Region of Enrollment

ITT population

Number

participants

Title

Denominators

Categories

North America

Title	Measurements
	BG00084 BG00187 BG002

Curative Intent

ITT population. Curative intent refers to radical prostatectomy or radiotherapy.

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00024 BG00130 BG002

Gleason Score

ITT population. 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. Gleason scores were unavailable for 3 patients.

Number

participants

Title

Denominators

Categories

2-4

Title	Measurements
	BG00021 BG001

Stage of Prostate Cancer

ITT population. Stage of prostate cancer was classified according to the Tumour, Nodule and Metastatic classification that is a cancer staging system that describes the extent of cancer. T describes the size of the tumor and whether it has invaded nearby tissue, N describes regional lymph nodes that are involved, and M describes distant metastasis

Number

participants

Title

Denominators

Categories

Localized

Title	Measurements
	BG00059 BG001

Body Mass Index

ITT population

Mean

Standard Deviation

kilogram per square meter

Title

Denominators

Categories

Title	Measurements
	BG00026.6± 3.70 BG00126.7± 4.21 BG002

Serum Prostate-specific Antigen Levels

Median

Inter-Quartile Range

nanogram per milliliter

Title

Denominators

Categories

Title	Measurements
	BG00019.9(8.2 to 68) BG00119.8(9.4 to 46) BG002

Serum Testosterone Levels

Median

Inter-Quartile Range

nanogram per milliliter

Title

Denominators

Categories

Title	Measurements
	BG0003.78(2.86 to 5.05) BG0014.11(3.05 to 5.32) BG002

Time Since Prostate Cancer Diagnosis

ITT population.

Mean

Standard Deviation

days

Title

Denominators

Categories

Title	Measurements
	BG000485± 1109 BG001491± 994 BG002

Weight

ITT population

Mean

Standard Deviation

kilogram

Title

Denominators

Categories

Title	Measurements
	BG00078.7± 13.0 BG00179.8± 14.9 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

Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364

Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.

Intent-to-treat (ITT) population.

Posted

Mean

95% Confidence Interval

percentage of patients

12 months

ID	Title	Description
OG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
OG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
OG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Units	Counts
Participants	OG000202 OG001207 OG002201

Title

Denominators

Categories

Title	Measurements
	OG00098.3(94.8 to 99.4) OG00197.2(93.5 to 98.8) OG00296.4(92.5 to 98.2)

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 OG002	A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364.					Difference in cumulative probability	1.9				97.5	-1.8	5.7				Yes	Non-Inferiority or Equivalence	The non-inferiority limit was -10 percentage points.

Secondary

Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment

A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).

ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.

Posted

Mean

95% Confidence Interval

percentage of patients

2 weeks

ID	Title	Description
OG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
OG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
OG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Secondary

Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3

This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.

ITT population.

Posted

Mean

95% Confidence Interval

percentage of patients

3 days

ID	Title	Description
OG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
OG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
OG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Units	Counts
Participants

Secondary

Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252

Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of <=-0.25, >-0.25-0, >0-0.25, >0.25-0.5 and >0.5 ng/mL from mean testosterone levels on Day 252.

ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.

Posted

Number

participants

Day 252, Day 255, and Day 259

ID	Title	Description
OG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
OG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
OG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Secondary

Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28

Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.

ITT population.

Posted

Median

Inter-Quartile Range

percent change

Days 14 and 28

ID	Title	Description
OG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
OG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
OG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Units	Counts
Participants

Secondary

Participants Grouped by Time to Prostate-specific Antigen Failure

The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.

ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.

Posted

Number

participants

12 months

ID	Title	Description
OG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
OG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
OG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Secondary

Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)

Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.

ITT population

Posted

Number

participants

Baseline to Day 364

ID	Title	Description
OG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
OG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
OG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Units	Counts
Participants

Secondary

The Mean Value of QTc Interval as Measured by Electrocardiogram

The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.

ITT population. End of Study values obtained at day 364 (+-7 days) for patients who completed. Patients who withdrew early had variable timeframes for the end of study value.

Posted

Mean

Standard Deviation

milliseconds

12 months

ID	Title	Description
OG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
OG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
OG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Secondary

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study 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 patients in each group with normal baseline and markedly abnormal value post-baseline.

ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.

Posted

Number

participants

12 months

ID	Title	Description
OG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
OG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
OG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected202 at risk EG0010 events0 affected207 at risk EG0023 events3 affected201 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Cardiac arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0012 events2 affected207 at risk EG0020 events0 affected201 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Angina unstable	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Bradycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Cardiac failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Coronary artery disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0021 events1 affected201 at risk
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0022 events2 affected201 at risk
Cardiac disorder	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Myopericarditis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Cataract	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Bronchopneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Ear infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Lobar pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Post procedural cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Prostate examination abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Blood creatinine increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Electrocardiogram (ECG) signs of myocardial ischaemia	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0011 events1 affected207 at risk EG0021 events1 affected201 at risk
Malignant lymphoma unclassifiable	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Linitis plastica	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Pleural mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Cerebral infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Hyperkinesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0012 events2 affected207 at risk EG0021 events1 affected201 at risk
Urinary retention	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected202 at risk EG0010 events0 affected207 at risk EG0022 events2 affected201 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Renal failure	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0020 events0 affected201 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0011 events1 affected207 at risk EG0020 events0 affected201 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected202 at risk EG0010 events0 affected207 at risk EG0021 events1 affected201 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected202 at risk EG0010 events0 affected207 at risk EG0023 events2 affected201 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00015 events11 affected202 at risk EG00110 events9 affected207 at risk EG0029 events8 affected201 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected202 at risk EG00112 events11 affected207 at risk EG00211 events10 affected201 at risk
Injection site pain	General disorders	MedDRA 10.0	Systematic Assessment	EG000108 events61 affected202 at risk EG001114 events58 affected207 at risk EG0021 events1 affected201 at risk
Injection site erythema	General disorders	MedDRA 10.0	Systematic Assessment	EG00063 events48 affected202 at risk EG00156 events36 affected207 at risk EG0020 events0 affected201 at risk
Injection site swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG00023 events14 affected202 at risk EG00117 events13 affected207 at risk EG0020 events0 affected201 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG00014 events13 affected202 at risk EG00111 events7 affected207 at risk EG00214 events13 affected201 at risk
Injection site induration	General disorders	MedDRA 10.0	Systematic Assessment	EG00014 events11 affected202 at risk EG00111 events8 affected207 at risk EG0020 events0 affected201 at risk
Injection site nodule	General disorders	MedDRA 10.0	Systematic Assessment	EG00024 events13 affected202 at risk EG0018 events6 affected207 at risk EG0020 events0 affected201 at risk
Chills	General disorders	MedDRA 10.0	Systematic Assessment	EG0009 events7 affected202 at risk EG00119 events11 affected207 at risk EG0020 events0 affected201 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected202 at risk EG00114 events10 affected207 at risk EG00225 events18 affected201 at risk
Weight increased	Investigations	MedDRA 10.0	Systematic Assessment	EG00022 events22 affected202 at risk EG00118 events18 affected207 at risk EG00224 events24 affected201 at risk
Alanine aminotransferase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG00017 events17 affected202 at risk EG00122 events20 affected207 at risk EG00211 events11 affected201 at risk
Aspartate aminostransferase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG00011 events10 affected202 at risk EG00112 events11 affected207 at risk EG0026 events6 affected201 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00012 events12 affected202 at risk EG0017 events7 affected207 at risk EG0025 events5 affected201 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00013 events12 affected202 at risk EG00112 events12 affected207 at risk EG00219 events17 affected201 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected202 at risk EG00112 events11 affected207 at risk EG00220 events18 affected201 at risk
Hot flush	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00059 events53 affected202 at risk EG00171 events53 affected207 at risk EG00250 events43 affected201 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00016 events14 affected202 at risk EG00112 events11 affected207 at risk EG0028 events8 affected201 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	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009479	Neuropeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009842	Oligopeptides
D009419	Nerve Tissue Proteins
D011506	Proteins

ID	Title	Description
BG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
BG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
BG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Other Events (Affected)
EG000	Degarelix 240/160 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.	24	165
EG001	Degarelix 240/80 mg	Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.	21	162
EG002	Leuprolide 7.5 mg	Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.	28	153

ID	Term
C431566	acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide
D016729	Leuprolide