Extension Study Investigating the Long-Term Safety of Deg... | NCT00268892

NCT00268892

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Degarelix 240/240@40(1-3-6-9)	Experimental	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).	Drug: Degarelix
Degarelix 240/240@60(1-3-6-9)	Experimental	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).	Drug: Degarelix
Degarelix 240/240@60(1-4-7-10)	Experimental	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).	Drug: Degarelix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Degarelix	Drug	Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL). Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.	Baseline and up to 4.5 years
Liver Function Tests	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.	4.5 years

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UZ Gasthuisberg Leuven		Leuven			Belgium
Helsinki University Hospital, Maria Hospital, Building 11

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Degarelix 240/240@40(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Degarelix 240/240@40(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
BG001	Degarelix 240/240@60(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
BG002	Degarelix 240/240@60(1-4-7-10)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00090 BG00195 BG00293 BG003278

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Safety analysis set.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00072.7± 6.55 BG00173.3± 7.00 BG00271.8± 7.05 BG003

Sex: Female, Male

Safety analysis set.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Race (NIH/OMB)

Safety analysis set.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Body Weight

Safety analysis set.

Mean

Standard Deviation

kilogram

Title

Denominators

Categories

Title	Measurements
	BG00076.7± 13.0 BG00176.9± 12.2 BG002

Body Mass Index

Safety analysis set.

Mean

Standard Deviation

kilogram per square meter

Title

Denominators

Categories

Title	Measurements
	BG00025.4± 4.14 BG00125.8± 3.93 BG002

Curative Intent

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

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00010 BG00112 BG002

Gleason Score

Safety analysis set. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive. A Gleason Score was missing for one participant in the Degarelix 240/240@60(1-3-6-9) group.

Number

participants

Title

Denominators

Categories

2-4

Title	Measurements
	BG00013 BG001

Stage of Prostate Cancer

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

Number

participants

Title

Denominators

Categories

Localized

Title	Measurements
	BG00034 BG001

Time since Prostate Cancer Diagnosis

Safety analysis set.

Mean

Standard Deviation

days

Title

Denominators

Categories

Title	Measurements
	BG000469± 1079 BG001347± 824 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 Markedly Abnormal Values in Vital Signs and Body Weight

This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.

The data include data from participants participating in both the main study (FE200486 CS15) and the extension study FE200486 CS15A.

Posted

Number

participants

Baseline and up to 4.5 years

ID	Title	Description
OG000	Degarelix 240/240@40(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
OG001	Degarelix 240/240@60(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
OG002	Degarelix 240/240@60(1-4-7-10)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).

Units	Counts
Participants	OG00090 OG00195 OG00293

Title

Denominators

Categories

Diastolic blood pressure <=50 and decrease >=15

Title	Measurements
	OG0005 OG0016 OG0024

Diastolic blood pressure >=105 and increase >=15

Primary

Liver Function Tests

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

Posted

Number

participants

4.5 years

ID	Title	Description
OG000	Degarelix 240/240@40(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
OG001	Degarelix 240/240@60(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
OG002	Degarelix 240/240@60(1-4-7-10)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Degarelix 240/240@40(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).	30	90	72	90
EG001	Degarelix 240/240@60(1-3-6-9)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).	24	95	75	95
EG002	Degarelix 240/240@60(1-4-7-10)	Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).	21	93	69	93

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial ischaemia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected95 at risk EG0021 events1 affected93 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Cardiac Failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Angina Pectoris	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Artrial Flutter	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Cardiac arrest	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Coronary artery disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Right ventricular failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Hypoparathyroidism	Endocrine disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Eye haemorrhage	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0012 events1 affected95 at risk EG0020 events0 affected93 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0021 events1 affected93 at risk
Volvulus	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0021 events1 affected93 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Ileus	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Disease progression	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Adverse drug reaction	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Sudden death	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Erysipelas	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0021 events1 affected93 at risk
Appendicitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Gastroenteritis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Mycotoxicosis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Pyelonephritis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Blood pressure increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Investigation	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Prostatic specific antigen increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Osteoarthiritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0022 events1 affected93 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected90 at risk EG0011 events1 affected95 at risk EG0021 events1 affected93 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0022 events2 affected93 at risk
Bladder transitional cell	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Metastates to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0021 events1 affected93 at risk
Cerebal infarction	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Hemiparesis	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Paraplegia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Agitation	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Confusional state	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected90 at risk EG0013 events3 affected95 at risk EG0020 events0 affected93 at risk
Haematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0012 events2 affected95 at risk EG0021 events1 affected93 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0014 events2 affected95 at risk EG0021 events1 affected93 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0021 events1 affected93 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Renal colic	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0022 events2 affected93 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0021 events1 affected93 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Arterial disorder	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected95 at risk EG0022 events1 affected93 at risk
Arterial stenosis limb	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected95 at risk EG0020 events0 affected93 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected95 at risk EG0020 events0 affected93 at risk
Presyncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected90 at risk EG0012 events1 affected95 at risk EG0020 events0 affected93 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events5 affected90 at risk EG0017 events7 affected95 at risk EG0026 events5 affected93 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG00012 events7 affected90 at risk EG00114 events9 affected95 at risk EG0026 events6 affected93 at risk
Cataract	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events6 affected90 at risk EG0011 events1 affected95 at risk EG0023 events3 affected93 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00010 events7 affected90 at risk EG0017 events6 affected95 at risk EG0024 events4 affected93 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events5 affected90 at risk EG00115 events10 affected95 at risk EG0022 events2 affected93 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected90 at risk EG0016 events6 affected95 at risk EG0028 events3 affected93 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected90 at risk EG0016 events4 affected95 at risk EG0028 events5 affected93 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events3 affected90 at risk EG0018 events5 affected95 at risk EG0025 events1 affected93 at risk
Injection Site Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG00055 events24 affected90 at risk EG00164 events24 affected95 at risk EG00236 events16 affected93 at risk
Injection Site Erythema	General disorders	MedDRA (10.0)	Systematic Assessment	EG00029 events15 affected90 at risk EG00132 events14 affected95 at risk EG0028 events6 affected93 at risk
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG00031 events12 affected90 at risk EG00120 events9 affected95 at risk EG00222 events7 affected93 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG00013 events10 affected90 at risk EG00114 events9 affected95 at risk EG0028 events8 affected93 at risk
Injection Site Swelling	General disorders	MedDRA (10.0)	Systematic Assessment	EG00012 events5 affected90 at risk EG00126 events10 affected95 at risk EG0023 events3 affected93 at risk
Injection Site Induration	General disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected90 at risk EG0015 events4 affected95 at risk EG0028 events4 affected93 at risk
Oedema Peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected90 at risk EG0016 events6 affected95 at risk EG0024 events4 affected93 at risk
Injection Site Nodule	General disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events6 affected90 at risk EG0017 events3 affected95 at risk EG0026 events4 affected93 at risk
Injection Site Mass	General disorders	MedDRA (10.0)	Systematic Assessment	EG00010 events5 affected90 at risk EG0012 events2 affected95 at risk EG0021 events1 affected93 at risk
Injection Site Pruritus	General disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events5 affected90 at risk EG0013 events2 affected95 at risk EG0027 events1 affected93 at risk
Urinary Tract Infection	General disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events6 affected90 at risk EG00117 events9 affected95 at risk EG0026 events6 affected93 at risk
Nasopharyngitis	General disorders	MedDRA (10.0)	Systematic Assessment	EG00010 events5 affected90 at risk EG00116 events9 affected95 at risk EG0025 events3 affected93 at risk
Influenza	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected90 at risk EG0015 events5 affected95 at risk EG0029 events7 affected93 at risk
Weight Increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG00012 events11 affected90 at risk EG00110 events9 affected95 at risk EG0027 events7 affected93 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected90 at risk EG0016 events5 affected95 at risk EG0025 events5 affected93 at risk
Weight Decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected90 at risk EG0017 events7 affected95 at risk EG0024 events4 affected93 at risk
Aspartate Aminotransferase Increase	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected90 at risk EG0014 events3 affected95 at risk EG0025 events5 affected93 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00013 events10 affected90 at risk EG00110 events7 affected95 at risk EG00214 events6 affected93 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00010 events9 affected90 at risk EG0017 events5 affected95 at risk EG00212 events6 affected93 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected90 at risk EG0012 events1 affected95 at risk EG0026 events3 affected93 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0009 events7 affected90 at risk EG00112 events9 affected95 at risk EG0026 events4 affected93 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events5 affected90 at risk EG0014 events4 affected95 at risk EG00220 events3 affected93 at risk
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events2 affected90 at risk EG0017 events7 affected95 at risk EG0021 events1 affected93 at risk
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected90 at risk EG0016 events5 affected95 at risk EG0022 events2 affected93 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events2 affected90 at risk EG0015 events5 affected95 at risk EG0024 events3 affected93 at risk
Hot Flush	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00033 events31 affected90 at risk EG00129 events27 affected95 at risk EG00238 events32 affected93 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events4 affected90 at risk EG0016 events6 affected95 at risk EG0025 events5 affected93 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events1 affected90 at risk EG0019 events5 affected95 at risk EG0020 events0 affected93 at risk

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

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