Trial Outcomes & Findings for A Degarelix Trial in Patients With Prostate Cancer (NCT NCT01242748)

NCT ID: NCT01242748

Last Updated: 2015-06-03

Results Overview

PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 288 participants
• Primary outcome timeframe: From baseline to 3 years
• Results posted on: 2015-06-03

Participant Flow

All participants who completed the main CS35 trial after initiation of the CS35A extension trial were eligible to enrol into CS35A.

Participants entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).

Participant milestones

Measure	Degarelix 240 mg/480 mg Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Overall Study STARTED	194	94
Overall Study CS35/CS35A Safety Analysis Set	565	283
Overall Study CS35/CS35A Full Analysis Set (FAS)	565	282
Overall Study COMPLETED	156	80
Overall Study NOT COMPLETED	38	14

Reasons for withdrawal

Measure	Degarelix 240 mg/480 mg Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Overall Study Adverse Event	10	5
Overall Study Lost to Follow-up	6	2
Overall Study Physician Decision	3	2
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	10	2
Overall Study Miscellaneous reasons	8	3

Baseline Characteristics

A Degarelix Trial in Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Degarelix 240 mg/480 mg n=194 Participants Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=94 Participants Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.	Total n=288 Participants Total of all reporting groups
Age, Continuous	73.1 years STANDARD_DEVIATION 8.4 • n=5 Participants	71.3 years STANDARD_DEVIATION 7.0 • n=7 Participants	72.5 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	194 Participants n=5 Participants	94 Participants n=7 Participants	288 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	34 Participants n=5 Participants	21 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	154 Participants n=5 Participants	68 Participants n=7 Participants	222 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Median Baseline Serum Testosterone Levels	4.41 nanogram per milliliter (ng/mL) n=5 Participants	4.65 nanogram per milliliter (ng/mL) n=7 Participants	4.52 nanogram per milliliter (ng/mL) n=5 Participants
Median Baseline Serum Prostate-specific Antigen Levels	20.6 ng/mL n=5 Participants	16.6 ng/mL n=7 Participants	18.7 ng/mL n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 3 years

Population: CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.

PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.

Outcome measures

Measure	Degarelix 240 mg/480 mg n=565 Participants Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=282 Participants Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin	75.5 percentage of no PSA-PFS Interval 69.1 to 80.7	75.4 percentage of no PSA-PFS Interval 64.5 to 83.4

SECONDARY outcome

Timeframe: From baseline to 3 years

Population: CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.

PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.

Outcome measures

Measure	Degarelix 240 mg/480 mg n=565 Participants Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=282 Participants Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin	71.5 percentage of no PFS failure Interval 66.0 to 76.2	69.0 percentage of no PFS failure Interval 58.0 to 77.7

SECONDARY outcome

Timeframe: From baseline to 3 years

Population: CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.

PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.

Outcome measures

Measure	Degarelix 240 mg/480 mg n=565 Participants Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=282 Participants Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin	77.5 percentage of no PSA failure Interval 71.0 to 82.7	79.6 percentage of no PSA failure Interval 68.9 to 86.9

SECONDARY outcome

Timeframe: From baseline to 3 years

Population: CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.

Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.

Outcome measures

Measure	Degarelix 240 mg/480 mg n=565 Participants Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=282 Participants Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin	83.7 percentage of no testosterone escape Interval 77.4 to 88.4	96.7 percentage of no testosterone escape Interval 93.7 to 98.2

SECONDARY outcome

Timeframe: From baseline to 3 years

Population: CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.

Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.

Outcome measures

Measure	Degarelix 240 mg/480 mg n=565 Participants Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=282 Participants Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin	84.5 percentage of no additional therapy Interval 80.0 to 88.1	83.4 percentage of no additional therapy Interval 77.3 to 88.0

SECONDARY outcome

Timeframe: From baseline to 3 years

Population: CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.

The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.

Outcome measures

Measure	Degarelix 240 mg/480 mg n=565 Participants Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=282 Participants Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin	4.6 percentage of deaths Interval 2.4 to 8.5	5.3 percentage of deaths Interval 2.6 to 10.5

SECONDARY outcome

Timeframe: Baseline and after 1, 6, 12, 19, and 22 months

Population: CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.

Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.

Outcome measures

Measure	Degarelix 240 mg/480 mg n=565 Participants Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=282 Participants Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin Baseline	4.52 ng/mL Interval 0.56 to 14.5	4.62 ng/mL Interval 0.07 to 13.2
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin Month 1	0.10 ng/mL Interval 0.015 to 3.85	0.16 ng/mL Interval 0.04 to 1.77
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin Month 6	0.09 ng/mL Interval 0.015 to 1.57	0.09 ng/mL Interval 0.015 to 0.32
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin Month 12	0.10 ng/mL Interval 0.015 to 1.1	0.09 ng/mL Interval 0.015 to 0.44
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin Month 19	0.11 ng/mL Interval 0.05 to 2.22	0.05 ng/mL Interval 0.05 to 0.43
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin Month 22	0.11 ng/mL Interval 0.05 to 3.4	0.05 ng/mL Interval 0.05 to 0.23

SECONDARY outcome

Timeframe: Baseline and after 1, 6, 12, 19, and 22 months

Population: CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.

Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.

Outcome measures

Measure	Degarelix 240 mg/480 mg n=565 Participants Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=282 Participants Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin Baseline	19 ng/mL Interval 0.26 to 8762.0	19.1 ng/mL Interval 0.005 to 12961.0
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin Month 1	3.79 ng/mL Interval 0.03 to 1540.0	6.5 ng/mL Interval 0.005 to 645.0
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin Month 6	0.82 ng/mL Interval 0.005 to 2648.0	0.73 ng/mL Interval 0.005 to 607.0
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin Month 12	0.6 ng/mL Interval 0.005 to 6889.0	0.43 ng/mL Interval 0.005 to 1802.0
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin Month 19	0.54 ng/mL Interval 0.005 to 712.0	0.28 ng/mL Interval 0.005 to 1150.0
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin Month 22	0.535 ng/mL Interval 0.005 to 252.0	0.26 ng/mL Interval 0.005 to 646.0

Adverse Events

Degarelix 240 mg/480 mg

Serious events: 58 serious events

Other events: 430 other events

Deaths: 0 deaths

Goserelin Acetate

Serious events: 33 serious events

Other events: 197 other events

Deaths: 0 deaths

Serious adverse events

Measure	Degarelix 240 mg/480 mg n=565 participants at risk Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=283 participants at risk Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Blood and lymphatic system disorders Anaemia	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.71% 2/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Acute myocardial infarction	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.71% 2/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Cardiac failure	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Coronary artery disease	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Angina pectoris	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Atrial fibrillation	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Cardiac failure acute	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Myocardial infarction	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Supraventricular tachycardia	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.71% 2/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Angina unstable	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Cardiac arrest	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Cardiac failure congestive	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Cardiac disorders Cardiopulmonary failure	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Congenital, familial and genetic disorders Phimosis	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Eye disorders Blindness transient	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Eye disorders Cataract	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Eye disorders Eye pain	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.53% 3/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Inguinal hernia	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Intestinal obstruction	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Abdominal hernia	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Dyspepsia	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Pancreatitis	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Sudden death	0.53% 3/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Asthenia	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Death	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Non-cardiac chest pain	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Oedema peripheral	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Pyrexia	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Sudden cardiac death	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Hepatobiliary disorders Cholecystitis	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Lobar pneumonia	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.71% 2/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Pneumonia	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.71% 2/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Sepsis	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Bronchopneumonia	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Cellulitis	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Gastroenteritis	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Injection site abscess	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Lung abscess	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Pyelonephritis acute	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Pyothorax	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Staphylococcal bacteraemia	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Staphylococcal infection	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Urinary tract infection	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Injury, poisoning and procedural complications Coronary artery reocclusion	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Injury, poisoning and procedural complications Dislocation of joint prosthesis	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Injury, poisoning and procedural complications Humerus fracture	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Metabolism and nutrition disorders Dehydration	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Metabolism and nutrition disorders Cachexia	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Metabolism and nutrition disorders Insulin-requiring type 2 diabetes mellitus	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Musculoskeletal and connective tissue disorders Back pain	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Musculoskeletal and connective tissue disorders Muscular weakness	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.71% 2/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Musculoskeletal and connective tissue disorders Prostate cancer	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour local invasion	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Nervous system disorders Ischaemic stroke	0.53% 3/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Nervous system disorders Syncope	0.53% 3/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Nervous system disorders Carotid artery stenosis	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Nervous system disorders Cerebrovascular accident	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Nervous system disorders Encephalopathy	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Nervous system disorders Haemorrhagic stroke	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Nervous system disorders Parkinson's disease	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Nervous system disorders Presyncope	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Nervous system disorders Transient ischaemic attack	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Psychiatric disorders Delirium	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Renal and urinary disorders Urinary retention	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Renal and urinary disorders Calculus bladder	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Renal and urinary disorders Haematuria	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Renal and urinary disorders Renal failure acute	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Renal and urinary disorders Acute prerenal failure	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Renal and urinary disorders Renal failure	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Renal and urinary disorders Renal failure chronic	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Renal and urinary disorders Urinary tract obstruction	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.71% 4/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	1.1% 3/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.35% 2/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.71% 2/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Vascular disorders Peripheral embolism	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.35% 1/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Vascular disorders Deep vein thrombosis	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Vascular disorders Hypertension	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Vascular disorders Peripheral ischaemia	0.18% 1/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.

Other adverse events

Measure	Degarelix 240 mg/480 mg n=565 participants at risk Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.	Goserelin Acetate n=283 participants at risk Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
General disorders Injection site pain	30.8% 174/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	1.4% 4/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Injection site erythema	21.8% 123/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Injection site nodule	9.2% 52/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Fatigue	4.8% 27/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	5.3% 15/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Pyrexia	5.5% 31/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	2.8% 8/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Injection site swelling	6.4% 36/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	0.00% 0/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
General disorders Oedema peripheral	2.3% 13/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	5.7% 16/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Infections and infestations Urinary tract infection	4.6% 26/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	6.4% 18/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Investigations Weight increased	4.8% 27/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	8.5% 24/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Musculoskeletal and connective tissue disorders Back pain	4.1% 23/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	8.1% 23/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Vascular disorders Hot flush	28.5% 161/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	26.9% 76/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Vascular disorders Hypertension	4.1% 23/565 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.	7.1% 20/283 • Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment). Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

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Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
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Restriction type: OTHER