A Long-term Extension Study Evaluating a One-Month Dosing... | NCT00451958

ID	Type	Description	Link
2006-006913-34	EudraCT Number

Label	Type	Description	Intervention Names
Degarelix 80 mg / Degarelix 80 mg	Experimental	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.	Drug: Degarelix 80 mg / Degarelix 80 mg
Degarelix 160 mg / Degarelix 160 mg	Experimental	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.	Drug: Degarelix 160 mg / Degarelix 160 mg
Leuprolide 7.5 mg / Degarelix 80 mg	Experimental	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Name	Type	Description	Arm Group Labels	Other Names
Degarelix 80 mg / Degarelix 80 mg	Drug		Degarelix 80 mg / Degarelix 80 mg	Firmagon

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 changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.	Up to 4 years of treatment
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.	Up to 4 years of treatment

Measure	Description	Time Frame
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression	PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).

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
South Orange County Medical Research Center

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.

ID	Title	Description
FG000	Degarelix 80 mg / Degarelix 80 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.

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 changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.

The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.

Posted

Number

participants

Up to 4 years of treatment

ID	Title	Description
OG000	Degarelix 80 mg / Degarelix 80 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
OG001	Degarelix 160 mg / Degarelix 160 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
OG002	Leuprolide 7.5 mg / Degarelix 80 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
OG003	Leuprolide 7.5 mg / Degarelix 160 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Units	Counts
Participants	OG000125 OG001126 OG00269 OG003

Title

Denominators

Categories

Diastolic blood pressure <=50 and decrease >=15

Title	Measurements
	OG0003 OG0016 OG0023 OG003

Primary

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.

The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.

Posted

Number

participants

Up to 4 years of treatment

ID	Title	Description
OG000	Degarelix 80 mg / Degarelix 80 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
OG001	Degarelix 160 mg / Degarelix 160 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Secondary

Percentage of Participants With no Prostate-specific Antigen (PSA) Progression

PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).

CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).

Posted

Number

95% Confidence Interval

percentage of participants

Until all participants have received at least 5 years of treatment and at a frequency of every 3 months

ID	Title	Description
OG000	Degarelix 80 mg / Degarelix 80 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
OG001	Degarelix 160 mg / Degarelix 160 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Secondary

Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards

The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.

In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study.

CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).

Posted

Number

95% Confidence Interval

percentage

Until all participants have received at least 5 years of treatment and at a frequency of every 6 months

ID	Title	Description
OG000	Degarelix 80 mg / Degarelix 80 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
OG001	Degarelix 160 mg / Degarelix 160 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Secondary

Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56

All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.

Posted

Median

Full Range

ng/mL

From time of switch to Day 56

ID	Title	Description
OG000	Leuprolide 7.5 mg/ Degarelix 240/80 mg	During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
OG001	Leuprolide 7.5 mg/ Degarelix 240/160 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Secondary

Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56

All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.

Posted

Median

Full Range

ng/mL

From time of switch to Day 56

ID	Title	Description
OG000	Leuprolide 7.5 mg/ Degarelix 240/80 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
OG001	Leuprolide 7.5 mg/ Degarelix 240/160 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Secondary

Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56

All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.

Posted

Median

Full Range

International units/Liter (IU/L)

From time of switch to Day 56

ID	Title	Description
OG000	Leuprolide 7.5 mg/ Degarelix 240/80 mg	During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
OG001	Leuprolide 7.5 mg/ Degarelix 240/160 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Secondary

Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56

All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.

Posted

Median

Full Range

International units/Liter (IU/L)

From time of switch to Day 56

ID	Title	Description
OG000	Leuprolide 7.5 mg/ Degarelix 240/80 mg	During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
OG001	Leuprolide 7.5 mg/ Degarelix 240/160 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0015 affected202 at risk EG0021 affected69 at risk EG0031 affected66 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Retroperitoneal lymphadenopathy	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0012 affected202 at risk EG0020 affected69 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0022 affected69 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0012 affected202 at risk EG0020 affected69 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0012 affected202 at risk EG0020 affected69 at risk EG003
Peritonitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Oedematous pancreatitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Rectal stenosis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Asthenia	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0022 affected69 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0021 affected69 at risk EG003
Accidental death	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Death	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Disease progression	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Feeling abnormal	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Multi-organ failure	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Oedema peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0012 affected202 at risk EG0020 affected69 at risk EG003
Arthritis infective	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Empyema	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Injection site abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Psoas abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Scrotal gangrene	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Septic shock	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Heart rate increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0022 affected69 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0003 affected207 at risk EG0014 affected202 at risk EG0021 affected69 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Colon cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Metastases to biliary tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Metastases to penis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Non-hodgkin's lymphoma unspecified histology indolent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Squamus cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0012 affected202 at risk EG0022 affected69 at risk EG003
Syncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0021 affected69 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0016 affected202 at risk EG0022 affected69 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0013 affected202 at risk EG0020 affected69 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0012 affected202 at risk EG0021 affected69 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0012 affected202 at risk EG0020 affected69 at risk EG003
Bladder obstruction	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0012 affected202 at risk EG0020 affected69 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0012 affected202 at risk EG0020 affected69 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Transurethral prostatectomy	Surgical and medical procedures	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0022 affected69 at risk EG003
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Pallor	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Varicose vein	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0021 affected69 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Myopericarditis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Inguinal hernia obstructive	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Ear infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Post procedural cellulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Blood creatinine increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
ECG signs of myocardial ischaemia	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Prostate examination abnormal	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0021 affected69 at risk EG003
Malignant lymphoma unclassifiable high grade	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Pleural mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Hyperkinesia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Urethral obstruction	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Hypotension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0021 affected69 at risk EG003
Squamus cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0011 affected202 at risk EG0020 affected69 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG00017 affected207 at risk EG00118 affected202 at risk EG00210 affected69 at risk EG0036 affected66 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0016 affected202 at risk EG0024 affected69 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0014 affected202 at risk EG0021 affected69 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00017 affected207 at risk EG00113 affected202 at risk EG00212 affected69 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00018 affected207 at risk EG00112 affected202 at risk EG0029 affected69 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00010 affected207 at risk EG00115 affected202 at risk EG0023 affected69 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected207 at risk EG0017 affected202 at risk EG0026 affected69 at risk EG003
Injection site pain	General disorders	MedDRA 14.0	Systematic Assessment	EG00065 affected207 at risk EG00167 affected202 at risk EG00220 affected69 at risk EG003
Injection site erythema	General disorders	MedDRA 14.0	Systematic Assessment	EG00040 affected207 at risk EG00151 affected202 at risk EG00210 affected69 at risk EG003
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG00020 affected207 at risk EG00122 affected202 at risk EG0028 affected69 at risk EG003
Injection site swelling	General disorders	MedDRA 14.0	Systematic Assessment	EG00017 affected207 at risk EG00116 affected202 at risk EG0026 affected69 at risk EG003
Fatigue	General disorders	MedDRA 14.0	Systematic Assessment	EG00012 affected207 at risk EG00115 affected202 at risk EG0029 affected69 at risk EG003
Asthenia	General disorders	MedDRA 14.0	Systematic Assessment	EG00013 affected207 at risk EG00113 affected202 at risk EG0028 affected69 at risk EG003
Injection site nodule	General disorders	MedDRA 14.0	Systematic Assessment	EG00013 affected207 at risk EG00117 affected202 at risk EG0024 affected69 at risk EG003
Injection site inflammation	General disorders	MedDRA 14.0	Systematic Assessment	EG0007 affected207 at risk EG0015 affected202 at risk EG0026 affected69 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00012 affected207 at risk EG00110 affected202 at risk EG00214 affected69 at risk EG003
Influenza	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00012 affected207 at risk EG00110 affected202 at risk EG0028 affected69 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00011 affected207 at risk EG0017 affected202 at risk EG0025 affected69 at risk EG003
Weight decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG00020 affected207 at risk EG00124 affected202 at risk EG00219 affected69 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 14.0	Systematic Assessment	EG00019 affected207 at risk EG00121 affected202 at risk EG0026 affected69 at risk EG003
Prostatic specific antigen increased	Investigations	MedDRA 14.0	Systematic Assessment	EG00016 affected207 at risk EG00120 affected202 at risk EG00210 affected69 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 14.0	Systematic Assessment	EG00015 affected207 at risk EG00114 affected202 at risk EG0027 affected69 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0008 affected207 at risk EG00115 affected202 at risk EG0027 affected69 at risk EG003
Blood creatinine increased	Investigations	MedDRA 14.0	Systematic Assessment	EG00011 affected207 at risk EG0019 affected202 at risk EG0025 affected69 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0007 affected207 at risk EG00111 affected202 at risk EG0023 affected69 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected207 at risk EG0014 affected202 at risk EG0027 affected69 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00020 affected207 at risk EG00120 affected202 at risk EG00210 affected69 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00018 affected207 at risk EG00114 affected202 at risk EG00214 affected69 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected207 at risk EG0019 affected202 at risk EG0027 affected69 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0008 affected207 at risk EG00145 affected202 at risk EG0024 affected69 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG00012 affected207 at risk EG00111 affected202 at risk EG0025 affected69 at risk EG003
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00013 affected207 at risk EG00114 affected202 at risk EG0025 affected69 at risk EG003
Headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00011 affected207 at risk EG00110 affected202 at risk EG0025 affected69 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG00010 affected207 at risk EG0019 affected202 at risk EG0022 affected69 at risk EG003
Depression	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected207 at risk EG00111 affected202 at risk EG0024 affected69 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected207 at risk EG00114 affected202 at risk EG0027 affected69 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG00010 affected207 at risk EG00111 affected202 at risk EG0024 affected69 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected207 at risk EG00111 affected202 at risk EG0026 affected69 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00014 affected207 at risk EG0018 affected202 at risk EG0025 affected69 at risk EG003
Hot flush	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG00062 affected207 at risk EG00163 affected202 at risk EG00220 affected69 at risk EG003
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG00019 affected207 at risk EG00127 affected202 at risk EG0028 affected69 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected207 at risk EG0012 affected202 at risk EG0021 affected69 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected207 at risk EG0018 affected202 at risk EG0021 affected69 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0015 affected202 at risk EG0024 affected69 at risk EG003
Chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0013 affected202 at risk EG0024 affected69 at risk EG003
Chills	General disorders	MedDRA 14.0	Systematic Assessment	EG00016 affected207 at risk EG00111 affected202 at risk EG0023 affected69 at risk EG003
Injection site induration	General disorders	MedDRA 14.0	Systematic Assessment	EG0009 affected207 at risk EG00113 affected202 at risk EG0021 affected69 at risk EG003
Oedema peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG0008 affected207 at risk EG0019 affected202 at risk EG0024 affected69 at risk EG003
Bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0008 affected207 at risk EG0016 affected202 at risk EG0024 affected69 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0004 affected207 at risk EG00110 affected202 at risk EG0025 affected69 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0006 affected207 at risk EG0018 affected202 at risk EG0024 affected69 at risk EG003
Blood urea increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0009 affected207 at risk EG0015 affected202 at risk EG0024 affected69 at risk EG003
Weight increased	Investigations	MedDRA 14.0	Systematic Assessment	EG00032 affected207 at risk EG00125 affected202 at risk EG00215 affected69 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00013 affected207 at risk EG00118 affected202 at risk EG0023 affected69 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected207 at risk EG0015 affected202 at risk EG0024 affected69 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected207 at risk EG0014 affected202 at risk EG0022 affected69 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected207 at risk EG0015 affected202 at risk EG0021 affected69 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0003 affected207 at risk EG0015 affected202 at risk EG0021 affected69 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0006 affected207 at risk EG0017 affected202 at risk EG0022 affected69 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0010 affected202 at risk EG0020 affected69 at risk EG003
Cystitis noninfective	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected207 at risk EG0012 affected202 at risk EG0020 affected69 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected207 at risk EG0015 affected202 at risk EG0022 affected69 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected207 at risk EG0014 affected202 at risk EG0022 affected69 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected207 at risk EG0014 affected202 at risk EG0023 affected69 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected207 at risk EG0014 affected202 at risk EG0021 affected69 at risk EG003

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 80 mg / Degarelix 80 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
BG001	Degarelix 160 mg / Degarelix 160 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
BG002	Leuprolide 7.5 mg / Degarelix 80 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
BG003	Leuprolide 7.5 mg / Degarelix 160 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Degarelix 80 mg / Degarelix 80 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.	43	207	181	207
EG001	Degarelix 160 mg / Degarelix 160 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.	60	202	177	202
EG002	Leuprolide 7.5 mg / Degarelix 80 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.	23	69	63	69
EG003	Leuprolide 7.5 mg / Degarelix 160 mg	During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.	22	66	58	66

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