Trial Outcomes & Findings for An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer (NCT NCT00215683)

Last Updated: 2015-04-01

Results Overview

Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

137 participants

Primary outcome timeframe

5 years

Results posted on

2015-04-01

Participant Flow

Participants who completed the main FE200486 CS12 study were asked to continue into the FE200486 CS12A extension study.

189 participants were randomized into the main study CS12 and 147 patients completed CS12. Of these, 137 participants were recruited into the extension study CS12A and 109 participants signed the informed consent for dose shift.

Participant milestones

Participant milestones
Measure	Degarelix 80 mg Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 120 mg Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 160 mg Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Overall Study STARTED	45	48	44
Overall Study Switched to 160 mg	32	41	36
Overall Study COMPLETED	16	22	12
Overall Study NOT COMPLETED	29	26	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Degarelix 80 mg Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 120 mg Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 160 mg Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Overall Study Adverse Event	15	16	15
Overall Study Lack of Efficacy	5	1	2
Overall Study Lost to Follow-up	0	2	1
Overall Study Withdrawal by Subject	9	4	13
Overall Study Physician Decision	0	0	1
Overall Study Difficult to attend visits	0	1	0
Overall Study No study drug available	0	1	0
Overall Study Intermittent therapy required	0	1	0

Baseline Characteristics

An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Degarelix 80 mg n=45 Participants Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 120 mg n=48 Participants Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 160 mg n=44 Participants Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Total n=137 Participants Total of all reporting groups
Age, Continuous	71.0 years STANDARD_DEVIATION 7.9 • n=5 Participants	70.8 years STANDARD_DEVIATION 6.3 • n=7 Participants	72.4 years STANDARD_DEVIATION 7.7 • n=5 Participants	71.4 years STANDARD_DEVIATION 7.3 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	48 Participants n=7 Participants	44 Participants n=5 Participants	137 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	44 Participants n=7 Participants	44 Participants n=5 Participants	133 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Body Weight	79.4 kilogram STANDARD_DEVIATION 15.9 • n=5 Participants	79.1 kilogram STANDARD_DEVIATION 13.2 • n=7 Participants	76.8 kilogram STANDARD_DEVIATION 12.4 • n=5 Participants	78.4 kilogram STANDARD_DEVIATION 13.9 • n=4 Participants
Body Mass Index	26.4 kilogram per square meter STANDARD_DEVIATION 4.5 • n=5 Participants	26.4 kilogram per square meter STANDARD_DEVIATION 3.4 • n=7 Participants	25.7 kilogram per square meter STANDARD_DEVIATION 3.4 • n=5 Participants	26.2 kilogram per square meter STANDARD_DEVIATION 3.8 • n=4 Participants
Curative Intent Yes	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	9 participants n=4 Participants
Curative Intent No	42 participants n=5 Participants	45 participants n=7 Participants	41 participants n=5 Participants	128 participants n=4 Participants
Gleason Score 2-4	10 participants n=5 Participants	11 participants n=7 Participants	5 participants n=5 Participants	26 participants n=4 Participants
Gleason Score 5-6	18 participants n=5 Participants	22 participants n=7 Participants	16 participants n=5 Participants	56 participants n=4 Participants
Gleason Score 7-10	17 participants n=5 Participants	15 participants n=7 Participants	22 participants n=5 Participants	54 participants n=4 Participants
Stage of Prostate Cancer Localized	10 participants n=5 Participants	14 participants n=7 Participants	8 participants n=5 Participants	32 participants n=4 Participants
Stage of Prostate Cancer Locally advanced	16 participants n=5 Participants	15 participants n=7 Participants	18 participants n=5 Participants	49 participants n=4 Participants
Stage of Prostate Cancer Metastatic	5 participants n=5 Participants	7 participants n=7 Participants	6 participants n=5 Participants	18 participants n=4 Participants
Stage of Prostate Cancer Not classifiable	14 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	38 participants n=4 Participants
Time since Prostate Cancer Diagnosis	355 days STANDARD_DEVIATION 645 • n=5 Participants	227 days STANDARD_DEVIATION 590 • n=7 Participants	457 days STANDARD_DEVIATION 1086 • n=5 Participants	343 days STANDARD_DEVIATION 798 • n=4 Participants

PRIMARY outcome

Timeframe: 5 years

Population: The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.

Outcome measures

Outcome measures
Measure	Degarelix 80 mg n=45 Participants Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 120 mg n=48 Participants Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 160 mg n=44 Participants Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Diastolic blood pressure <=50 and decrease >=15	3 participants	5 participants	10 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Diastolic blood pressure >=105 and increase >=15	9 participants	5 participants	9 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Systolic blood pressure <=90 and decrease >=20	1 participants	2 participants	2 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Systolic blood pressure >=180 and increase >=20	4 participants	9 participants	8 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Heart rate <=50 and decrease >=15	3 participants	5 participants	5 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Heart rate >=120 and increase >=15	1 participants	1 participants	0 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Body weight decrease of >=7 percent	4 participants	10 participants	8 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Body weight increase of >=7 percent	18 participants	19 participants	14 participants

PRIMARY outcome

Timeframe: 5 years

Population: The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.

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

Outcome measures

Outcome measures
Measure	Degarelix 80 mg n=45 Participants Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 120 mg n=48 Participants Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 160 mg n=44 Participants Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Liver Function Tests Abnormal alanine aminotransferase (ALAT)	19 participants	18 participants	23 participants
Liver Function Tests Abnormal aspartate aminotransferase	18 participants	23 participants	21 participants
Liver Function Tests Abnormal bilirubin	8 participants	11 participants	3 participants
Liver Function Tests ALAT >3x upper limit of normal (ULN)	3 participants	3 participants	3 participants
Liver Function Tests ALAT >3x ULN, bilirubin >1.5x ULN	0 participants	0 participants	0 participants

Adverse Events

Degarelix 80 mg

Serious events: 19 serious events

Other events: 35 other events

Deaths: 0 deaths

Degarelix 120 mg

Serious events: 20 serious events

Other events: 41 other events

Deaths: 0 deaths

Degarelix 160 mg

Serious events: 10 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Ferring Pharmaceuticals

Clinical Development Support

Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Degarelix 80 mg n=45 participants at risk Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 120 mg n=48 participants at risk Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 160 mg n=44 participants at risk Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Infections and infestations Bronchitis	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Bronchopneumonia	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Gastrointestinal disorders Gastroenteritis	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Musculoskeletal and connective tissue disorders Intravertebral disc compression	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Gastroenteritis viral	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Sepsis	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Urinary tract infection	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Injury, poisoning and procedural complications Femoral neck fracture	4.4% 2/45 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.2% 3/48 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	4.4% 2/45 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Musculoskeletal and connective tissue disorders Acoustic neuroma	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign colonic neoplasm	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Injury, poisoning and procedural complications Spinal compression fracture	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Investigations Angiogram	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Investigations Blood potassium increased	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Metabolism and nutrition disorders Dehydration	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ of eye	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Musculoskeletal and connective tissue disorders Back pain	4.4% 2/45 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Blood and lymphatic system disorders Anaemia	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Angina pectoris	4.4% 2/45 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Atrial fibrillation	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Cardiopulmonary failure	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Ventricular tachycardia	2.2% 1/45 • Number of events 10 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Acute myocardial infarction	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Atrioventricular block	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Cardiac failure	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Cardiac failure acute	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Myocardial infarction	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Supraventricular tachycardia	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Tachyarrhythmia	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Eye disorders Corneal defect	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Eye disorders Neurotrophic keratopathy	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Eye disorders Ulcerative keratitis	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 8 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.

Other adverse events
Measure	Degarelix 80 mg n=45 participants at risk Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 120 mg n=48 participants at risk Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix 160 mg n=44 participants at risk Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Skin and subcutaneous tissue disorders Alopecia	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.2% 3/48 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.8% 3/44 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Skin and subcutaneous tissue disorders Pruritus	6.7% 3/45 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.2% 1/45 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Vascular disorders Hot flush	42.2% 19/45 • Number of events 27 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	37.5% 18/48 • Number of events 18 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	38.6% 17/44 • Number of events 20 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Vascular disorders Orthostatic hypertension	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Vascular disorders Hypertension	6.7% 3/45 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.2% 3/48 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.8% 3/44 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Blood and lymphatic system disorders Anaemia	6.7% 3/45 • Number of events 6 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Atrial fibrillation	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	8.3% 4/48 • Number of events 5 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Atrioventricular block first degree	6.7% 3/45 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.2% 3/48 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Myocardial ischaemia	4.4% 2/45 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.2% 2/48 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Bradycardia	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Cardiac disorders Ventricular extrasystoles	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	8.3% 4/48 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Ear and labyrinth disorders Vertigo	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Eye disorders Cataract	4.4% 2/45 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.2% 2/48 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.8% 3/44 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Gastrointestinal disorders Constipation	15.6% 7/45 • Number of events 9 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.2% 2/48 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Gastrointestinal disorders Diarrhoea	6.7% 3/45 • Number of events 6 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	10.4% 5/48 • Number of events 5 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	13.6% 6/44 • Number of events 7 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Gastrointestinal disorders Nausea	11.1% 5/45 • Number of events 7 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	9.1% 4/44 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Gastrointestinal disorders Abdominal pain	4.4% 2/45 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Gastrointestinal disorders Dyspepsia	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.2% 3/48 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/44 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Injection site pain	13.3% 6/45 • Number of events 28 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	22.9% 11/48 • Number of events 22 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	29.5% 13/44 • Number of events 48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Fatigue	13.3% 6/45 • Number of events 8 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.2% 3/48 • Number of events 7 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	13.6% 6/44 • Number of events 9 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Pyrexia	13.3% 6/45 • Number of events 7 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.2% 3/48 • Number of events 6 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	13.6% 6/44 • Number of events 11 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Injection site erythema	6.7% 3/45 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.2% 2/48 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	20.5% 9/44 • Number of events 15 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Injection site nodule	6.7% 3/45 • Number of events 7 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	10.4% 5/48 • Number of events 6 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	11.4% 5/44 • Number of events 5 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Injection site swelling	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	8.3% 4/48 • Number of events 9 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	13.6% 6/44 • Number of events 13 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Oedema peripheral	8.9% 4/45 • Number of events 6 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	8.3% 4/48 • Number of events 6 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Asthenia	8.9% 4/45 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.2% 2/48 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Injection site inflammation	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.2% 3/48 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	9.1% 4/44 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Chest pain	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Hyperthermia	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.1% 1/48 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Injection site haematoma	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
General disorders Injection site reaction	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.8% 3/44 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Influenza	13.3% 6/45 • Number of events 8 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	18.8% 9/48 • Number of events 15 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	18.2% 8/44 • Number of events 9 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Urinary tract infection	8.9% 4/45 • Number of events 6 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	12.5% 6/48 • Number of events 11 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	9.1% 4/44 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Bronchitis	8.9% 4/45 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.2% 2/48 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	11.4% 5/44 • Number of events 8 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Nasopharyngitis	4.4% 2/45 • Number of events 7 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.2% 2/48 • Number of events 4 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	9.1% 4/44 • Number of events 8 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Pneumonia	6.7% 3/45 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.2% 2/48 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.8% 3/44 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Gastroenteritis	4.4% 2/45 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	6.2% 3/48 • Number of events 3 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	4.5% 2/44 • Number of events 2 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Rhinitis	2.2% 1/45 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	0.00% 0/48 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	9.1% 4/44 • Number of events 5 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.
Infections and infestations Upper respiratory tract infection	0.00% 0/45 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	8.3% 4/48 • Number of events 5 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.	2.3% 1/44 • Number of events 1 • 5 years Each patient's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the patient's Case Report Form.