Trial Outcomes & Findings for Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer (NCT NCT01071915)

NCT ID: NCT01071915

Last Updated: 2013-02-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 157 participants
• Primary outcome timeframe: Day 28 to Day 196
• Results posted on: 2013-02-12

Participant Flow

The patients were recruited from 11 sites in Korea. The study was conducted between 08 March 2010 (FPFV) and 07 November 2011 (LPLV).

Participant milestones

Measure	Degarelix 240/80 mg The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Study STARTED	157
Overall Study Full Analysis Set (FAS)	155
Overall Study Safety Analysis Set	156
Overall Study COMPLETED	148
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Degarelix 240/80 mg The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Study Adverse Event	3
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	2
Overall Study Miscellaneous Reasons	2

Baseline Characteristics

Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Degarelix 240/80 mg n=155 Participants The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Age Continuous	72.6 years STANDARD_DEVIATION 8.08 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	155 Participants n=5 Participants
Region of Enrollment Korea, Republic of	155 participants n=5 Participants
Body Mass Index (BMI)	23.8 kilogram per square meter STANDARD_DEVIATION 2.98 • n=5 Participants
Gleason Score Gleason Score 2-4	0 Participants n=5 Participants
Gleason Score Gleason Score 5-6	24 Participants n=5 Participants
Gleason Score Gleason Score 7-10	130 Participants n=5 Participants
Stage of Prostate Cancer Localized	43 Participants n=5 Participants
Stage of Prostate Cancer Locally Advanced	60 Participants n=5 Participants
Stage of Prostate Cancer Metastatic	39 Participants n=5 Participants
Stage of Prostate Cancer Not Classifiable	13 Participants n=5 Participants
Serum Testosterone Level	4.03 nanograms per milliliter (ng/mL) n=5 Participants
Serum Protsate-Specific Antigen (PSA) Levels	19.2 ng/mL n=5 Participants

PRIMARY outcome

Timeframe: Day 28 to Day 196

Population: 152 participants for this outcome measure is the analysis population from day 28 to day 196

Outcome measures

Measure	Degarelix 240/80 mg n=152 Participants The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196	96.7 percent probability Interval 92.2 to 98.6

SECONDARY outcome

Timeframe: At day 3

Population: Observed cases

Outcome measures

Measure	Degarelix 240/80 mg n=154 Participants The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3	97.4 percent Interval 93.5 to 99.3

SECONDARY outcome

Timeframe: To Day 28

Population: 152 participants for this outcome measure is the analysis population from day 0 to day 28

Outcome measures

Measure	Degarelix 240/80 mg n=152 Participants The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28	-79.7 percent Interval -90.5 to -64.5

SECONDARY outcome

Timeframe: Day 56 to Day 196

Population: 152 participants for this outcome measure is the analysis population from day 56 to day 196

Outcome measures

Measure	Degarelix 240/80 mg n=152 Participants The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196	96.7 percent probability Interval 92.2 to 98.6

SECONDARY outcome

Timeframe: To Day 196

Population: 152 participants for this outcome measure is the analysis population from day 28 to day 196

PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.

Outcome measures

Measure	Degarelix 240/80 mg n=152 Participants The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Cumulative Probability of no PSA Failure From Day 28 to Day 196	97.3 percent probability Interval 93.1 to 99.0

SECONDARY outcome

Timeframe: To Day 196

Population: Safety analysis population

The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.

Outcome measures

Measure	Degarelix 240/80 mg n=156 Participants The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Haematocrit (Ratio) <=0.37	73 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Haemoglobin (g/L) <=115	5 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-White blood cell count (10^9/L) <=2.8	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-White blood cell count (10^9/L) >=16.0	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Red blood cell count (10^12/L) <=3.5	19 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Alanine aminotransferase (IU/L) >3xULN	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Potassium (mmol/L) >=5.8	10 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Sodium (mmol/L) <=130	2 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Urea nitrogen (mmol/L) >=10.7	8 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Lymphocytes (%) <=10	4 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Eosinophils (%) >=10	7 participants

SECONDARY outcome

Timeframe: To Day 196

Population: Safety analyis population

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

Outcome measures

Measure	Degarelix 240/80 mg n=156 Participants The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Diastolic blood pressure <=50 and decrease >=15	6 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Diastolic blood pressure >=105 and increase >=15	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Systolic blood pressure <=90 and decrease >=20	12 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Systolic blood pressure >=180 and increase >=20	1 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Heart rate <=50 and decrease >=15	4 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Heart rate >=120 and increase >=15	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Body weight decrease of >=7 percent	4 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Body weight increase of >=7 percent	12 participants

Adverse Events

Degarelix 240/80 mg

Serious events: 18 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Measure	Degarelix 240/80 mg n=156 participants at risk The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Cardiac disorders Angina pectoris	0.64% 1/156 • 7 months (196 days) 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 Angina unstable	0.64% 1/156 • 7 months (196 days) 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 Atrial fibrillation	0.64% 1/156 • 7 months (196 days) 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 occlusion	0.64% 1/156 • 7 months (196 days) 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 Myocardial ischaemia	0.64% 1/156 • 7 months (196 days) 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 Constipation	0.64% 1/156 • 7 months (196 days) 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	0.64% 1/156 • 7 months (196 days) 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	0.64% 1/156 • 7 months (196 days) 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 Disease progression	0.64% 1/156 • 7 months (196 days) 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	0.64% 1/156 • 7 months (196 days) 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 Herpes zoster	0.64% 1/156 • 7 months (196 days) 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 Influenza	0.64% 1/156 • 7 months (196 days) 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 Upper respiratory tract infection	0.64% 1/156 • 7 months (196 days) 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 Drug toxicity	0.64% 1/156 • 7 months (196 days) 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 Spinal compression fracture	0.64% 1/156 • 7 months (196 days) 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.
Metabolism and nutrition disorders Anorexia	0.64% 1/156 • 7 months (196 days) 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.
Metabolism and nutrition disorders Hyperglycaemia	0.64% 1/156 • 7 months (196 days) 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 Back pain	0.64% 1/156 • 7 months (196 days) 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 Flank pain	0.64% 1/156 • 7 months (196 days) 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) Metastases to prostate	0.64% 1/156 • 7 months (196 days) 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) Metastatic pain	0.64% 1/156 • 7 months (196 days) 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 Paraplegia	0.64% 1/156 • 7 months (196 days) 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 Spinal cord compression	0.64% 1/156 • 7 months (196 days) 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 Dysuria	0.64% 1/156 • 7 months (196 days) 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 Haematuria	0.64% 1/156 • 7 months (196 days) 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	0.64% 1/156 • 7 months (196 days) 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.
Reproductive system and breast disorders Pelvic pain	0.64% 1/156 • 7 months (196 days) 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.
Reproductive system and breast disorders Penile pain	0.64% 1/156 • 7 months (196 days) 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.
Reproductive system and breast disorders Perineal pain	0.64% 1/156 • 7 months (196 days) 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 Dyspnoea	0.64% 1/156 • 7 months (196 days) 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.
Surgical and medical procedures Ureteral stent removal	0.64% 1/156 • 7 months (196 days) 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.

Other adverse events

Measure	Degarelix 240/80 mg n=156 participants at risk The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Gastrointestinal disorders Constipation	8.3% 13/156 • 7 months (196 days) 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 Diarrhoea	4.5% 7/156 • 7 months (196 days) 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 Dyspepsia	3.2% 5/156 • 7 months (196 days) 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 Injection site pain	21.8% 34/156 • 7 months (196 days) 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 Injection site erythema	8.3% 13/156 • 7 months (196 days) 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 Injection site induration	3.8% 6/156 • 7 months (196 days) 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 Oedema peripheral	3.8% 6/156 • 7 months (196 days) 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 Fatigue	3.2% 5/156 • 7 months (196 days) 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 Upper respiratory tract	7.7% 12/156 • 7 months (196 days) 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 Back pain	3.2% 5/156 • 7 months (196 days) 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 Headache	4.5% 7/156 • 7 months (196 days) 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 Dizziness	3.8% 6/156 • 7 months (196 days) 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 Insomnia	4.5% 7/156 • 7 months (196 days) 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 Nocturia	6.4% 10/156 • 7 months (196 days) 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 Dysuria	3.8% 6/156 • 7 months (196 days) 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 Haematuria	3.2% 5/156 • 7 months (196 days) 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	9.0% 14/156 • 7 months (196 days) 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 Hot flush	3.2% 5/156 • 7 months (196 days) 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 Flushing	3.2% 5/156 • 7 months (196 days) 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.

Additional Information

Ferring Pharmaceuticals

Clinical Development Support

Email: DK0-Disclosure@ferring.com

Results disclosure agreements

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