A Trial of Degarelix in Patients With Prostate Cancer | NCT00946920

ID	Type	Description	Link
2008-005276-27	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Degarelix 240 mg/480 mg	Experimental		Drug: Degarelix
Goserelin acetate	Active Comparator		Drug: Goserelin acetate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Degarelix	Drug	The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix	This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.	From Day 28 to Day 364
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin	This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.	Day 3 to Day 364

Secondary Outcomes

Measure	Description	Time Frame
Serum Levels of Testosterone Over Time	Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.	Baseline and after 1, 2, 3, 6 and 13 months
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time

Eligibility Module

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Urology Centers Of Alabama		Homewood	Alabama		United States
Arkansas Urology

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34350976	Derived	Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
BG001	Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00071.9± 8.3 BG00171.1± 7.9 BG00271.6± 8.2

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	BG00045 BG00125 BG002

Median Baseline Serum Testosterone Levels (ng/mL)

Median

Full Range

ng/mL

Title

Denominators

Categories

Title	Measurements
	BG0004.52(0.56 to 14.5) BG0014.62(0.07 to 13.2) BG002

Median Baseline Serum Prostate-specific Antigen Levels (ng/mL)

Median

Full Range

ng/mL

Title

Denominators

Categories

Title	Measurements
	BG00019.0(0.26 to 8762) BG00119.1(0.01 to 12961) BG002

Baseline Short Form-36 (SF-36) Total Scores

The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00049.7± 11.5 BG001

Baseline Total International Prostate Symptom Scores (IPSS)

IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and a score of 5 corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00011.8± 7.93 BG001

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

Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix

This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.

FAS.

Posted

Number

95% Confidence Interval

percentage of participants

From Day 28 to Day 364

ID	Title	Description
OG000	Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).

Units	Counts
Participants	OG000565

Title

Denominators

Categories

Title	Measurements
	OG00090.0(87.0 to 92.3)

Primary

Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin

This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.

FAS.

Posted

Number

95% Confidence Interval

percentage of participants

Day 3 to Day 364

ID	Title	Description
OG000	Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
OG001	Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Units

Secondary

Serum Levels of Testosterone Over Time

Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.

FAS.

Posted

Median

Full Range

ng/mL

Baseline and after 1, 2, 3, 6 and 13 months

ID	Title	Description
OG000	Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
OG001	Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Units	Counts
Participants

Secondary

Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time

Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.

FAS.

Posted

Mean

Standard Deviation

percent change

Baseline and after 1, 2, 3, 6 and 13 months

ID	Title	Description
OG000	Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
OG001	Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Units	Counts
Participants

Secondary

Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline

FAS.

Posted

Mean

Standard Deviation

units on a scale

At baseline, 10 months and 13 months

ID	Title	Description
OG000	Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
OG001	Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Secondary

Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline

FAS.

Posted

Mean

Standard Deviation

units on a scale

At baseline, 1 month, 4 months, 7 months and 13 months

ID	Title	Description
OG000	Degarelix 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
OG001	Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Arm/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 240 mg/480 mg	Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).			58	565	336	565
EG001	Goserelin Acetate	Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).			33	283	125	283

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0012 affected283 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0010 affected283 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0010 affected283 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0010 affected283 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0012 affected283 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0011 affected283 at risk
Angina unstable	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0011 affected283 at risk
Cardiac arrest	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0011 affected283 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Cataract	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Eye pain	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0010 affected283 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0011 affected283 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0010 affected283 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Death	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Oedema peripheral	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Sudden cardiac death	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Sudden death	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Lobar pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0012 affected283 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0012 affected283 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Infective exacerbation of chronic obstructive airways	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Injection site abscess	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Lung abscess	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Pyothorax	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Sepsis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0011 affected283 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Staphylococcal infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Coronary artery reocclusion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0010 affected283 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Insulin-requiring type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0012 affected283 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0010 affected283 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0010 affected283 at risk
Chronic myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Tumour local invasion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected565 at risk EG0011 affected283 at risk
Syncope	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected565 at risk EG0010 affected283 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Encephalopathy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Parkinson's disease	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Delirium	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Haematuria	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0011 affected283 at risk
Renal failure	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Urinary retention	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0011 affected283 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0003 affected565 at risk EG0013 affected283 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected565 at risk EG0012 affected283 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0011 affected283 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected565 at risk EG0011 affected283 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk
Peripheral embolism	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0011 affected283 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected565 at risk EG0010 affected283 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hot flush	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG000175 events160 affected565 at risk EG00180 events76 affected283 at risk
Injection site pain	General disorders	MedDRA 13.0	Systematic Assessment	EG000429 events173 affected565 at risk EG0014 events4 affected283 at risk
Injection site erythema	General disorders	MedDRA 13.0	Systematic Assessment	EG000323 events122 affected565 at risk EG0010 events0 affected283 at risk
Injection site nodule	General disorders	MedDRA 13.0	Systematic Assessment	EG000112 events51 affected565 at risk EG0010 events0 affected283 at risk
Weight increased	Investigations	MedDRA 13.0	Systematic Assessment	EG00026 events26 affected565 at risk EG00124 events24 affected283 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00030 events24 affected565 at risk EG00124 events18 affected283 at risk
Fatigue	General disorders	MedDRA 13.0	Systematic Assessment	EG00028 events26 affected565 at risk EG00115 events15 affected283 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00021 events19 affected565 at risk EG00127 events21 affected283 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG00024 events22 affected565 at risk EG00121 events18 affected283 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG00040 events31 affected565 at risk EG0017 events7 affected283 at risk
Injection site swelling	General disorders	MedDRA 13.0	Systematic Assessment	EG000102 events34 affected565 at risk EG0010 events0 affected283 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	Term
C431566	acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide
D017273	Goserelin