Trial Outcomes & Findings for Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer (NCT NCT00117286)

Last Updated: 2025-12-18

Results Overview

This outcome measure 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

57 participants

Primary outcome timeframe

5 years

Results posted on

2025-12-18

Participant Flow

Participants who completed the main FE200486 CS14 study were asked to continue into the FE200486 CS14A extension study.

127 participants started and 87 participants completed the main CS14 study. Of these, 57 participants were recruited into the extension study CS14A and 34 participants signed the informed consent for dose shift.

Participant milestones

Participant milestones
Measure	Degarelix (60 mg to 160 mg) Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix (80 mg to 160 mg) Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Overall Study STARTED	30	27
Overall Study Switched to Higher Dose	17	17
Overall Study COMPLETED	2	6
Overall Study NOT COMPLETED	28	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Degarelix (60 mg to 160 mg) Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix (80 mg to 160 mg) Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Overall Study Adverse Event	12	6
Overall Study Lost to Follow-up	2	0
Overall Study Protocol Violation	3	3
Overall Study Withdrawal by Subject	6	2
Overall Study Physician Decision	3	7
Overall Study Lack of Efficacy	2	1
Overall Study Research site closing	0	2

Baseline Characteristics

Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Degarelix (60 mg to 160 mg) n=30 Participants Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix (80 mg to 160 mg) n=27 Participants Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Total n=57 Participants Total of all reporting groups
Age, Continuous	76.0 years STANDARD_DEVIATION 6.63 • n=47 Participants	74.1 years STANDARD_DEVIATION 8.85 • n=41 Participants	75.1 years STANDARD_DEVIATION 7.75 • n=88 Participants
Sex: Female, Male Female	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants
Sex: Female, Male Male	30 Participants n=47 Participants	27 Participants n=41 Participants	57 Participants n=88 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Asian	1 Participants n=47 Participants	0 Participants n=41 Participants	1 Participants n=88 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Black or African American	5 Participants n=47 Participants	2 Participants n=41 Participants	7 Participants n=88 Participants
Race (NIH/OMB) White	24 Participants n=47 Participants	25 Participants n=41 Participants	49 Participants n=88 Participants
Race (NIH/OMB) More than one race	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants
Body weight	79.0 kilogram STANDARD_DEVIATION 11.4 • n=47 Participants	81.3 kilogram STANDARD_DEVIATION 13.3 • n=41 Participants	80.1 kilogram STANDARD_DEVIATION 12.2 • n=88 Participants
Body mass index	26.5 kilogram per square meter STANDARD_DEVIATION 3.64 • n=47 Participants	26.6 kilogram per square meter STANDARD_DEVIATION 4.63 • n=41 Participants	26.5 kilogram per square meter STANDARD_DEVIATION 4.10 • n=88 Participants
Curative Intent Yes	11 participants n=47 Participants	11 participants n=41 Participants	22 participants n=88 Participants
Curative Intent No	19 participants n=47 Participants	16 participants n=41 Participants	35 participants n=88 Participants
Gleason Score 2-4	2 participants n=47 Participants	1 participants n=41 Participants	3 participants n=88 Participants
Gleason Score 5-6	5 participants n=47 Participants	8 participants n=41 Participants	13 participants n=88 Participants
Gleason Score 7-10	23 participants n=47 Participants	18 participants n=41 Participants	41 participants n=88 Participants
Stage of Prostate Cancer Localized	14 participants n=47 Participants	7 participants n=41 Participants	21 participants n=88 Participants
Stage of Prostate Cancer Locally advanced	3 participants n=47 Participants	5 participants n=41 Participants	8 participants n=88 Participants
Stage of Prostate Cancer Metastatic	5 participants n=47 Participants	5 participants n=41 Participants	10 participants n=88 Participants
Stage of Prostate Cancer Not classifiable	8 participants n=47 Participants	10 participants n=41 Participants	18 participants n=88 Participants
Time since Prostate Cancer Diagnosis	1253 days STANDARD_DEVIATION 1565 • n=47 Participants	1349 days STANDARD_DEVIATION 1625 • n=41 Participants	1299 days STANDARD_DEVIATION 1580 • n=88 Participants

PRIMARY outcome

Timeframe: 5 years

Population: The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.

Outcome measures

Outcome measures
Measure	Degarelix (60 mg to 160 mg) n=30 Participants Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix (80 mg to 160 mg) n=27 Participants Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 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	9 participants	4 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Diastolic blood pressure >=105 and increase >=15	3 participants	3 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Systolic blood pressure <=90 and decrease >=20	3 participants	7 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Systolic blood pressure >=180 and increase >=20	5 participants	4 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Heart rate <=50 and decrease >=15	2 participants	6 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Heart rate >=120 and increase >=15	1 participants	0 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Body weight decrease of >=7 percent	6 participants	4 participants
Participants With Markedly Abnormal Change in Vital Signs and Body Weight Body weight increase of >=7 percent	6 participants	5 participants

PRIMARY outcome

Timeframe: 5 years

Population: The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.

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 (60 mg to 160 mg) n=30 Participants Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix (80 mg to 160 mg) n=27 Participants Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Liver Function Tests ALAT >3x ULN, bilirubin >1.5x ULN	0 participants	0 participants
Liver Function Tests Abnormal aspartate aminotransferase	5 participants	4 participants
Liver Function Tests Abnormal bilirubin	7 participants	5 participants
Liver Function Tests ALAT >3x upper limit of normal (ULN)	0 participants	0 participants
Liver Function Tests Abnormal alanine aminotransferase (ALAT)	8 participants	11 participants

Adverse Events

Degarelix (60 mg to 160 mg)

Serious events: 11 serious events

Other events: 29 other events

Deaths: 0 deaths

Degarelix (80 mg to 160 mg)

Serious events: 7 serious events

Other events: 26 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

Measure	Degarelix (60 mg to 160 mg) n=30 participants at risk Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	Degarelix (80 mg to 160 mg) n=27 participants at risk Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Cardiac disorders Cardiac failure congestive	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Cardiac disorders Coronary artery disease	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Ear and labyrinth disorders Vertigo	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Gastrointestinal disorders Hiatus hernia	6.7% 2/30 • Number of events 2 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Gastrointestinal disorders Diverticulum	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Gastrointestinal disorders Nausea	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
General disorders Asthenia	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
General disorders General physcial health deterioration	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Infections and infestations Pneumonia	10.0% 3/30 • Number of events 3 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Infections and infestations Appendiceal abscess	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Infections and infestations Appendicitis perforated	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Infections and infestations Gastroenteritis viral	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Infections and infestations Respiratory tract infection	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Injury, poisoning and procedural complications Pelvic fracture	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Musculoskeletal and connective tissue disorders Muscular weakness	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis to central nervous system	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Nervous system disorders Carotid artery occlusion	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Nervous system disorders Subarachnoid haemorrhage	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Nervous system disorders Transient ischaemic attack	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.
Renal and urinary disorders Urinary retention	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.3% 1/30 • Number of events 4 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 2 • 5 years. Each participant'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 participant's Case Report Form.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Vascular disorders Aortic aneurysm	0.00% 0/30 • 5 years. Each participant'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 participant's Case Report Form.	3.7% 1/27 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.
Vascular disorders Deep vein thrombosis	3.3% 1/30 • Number of events 1 • 5 years. Each participant'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 participant's Case Report Form.	0.00% 0/27 • 5 years. Each participant'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 participant's Case Report Form.