Trial Outcomes & Findings for Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients (NCT NCT01215513)
NCT ID: NCT01215513
Last Updated: 2013-05-22
Results Overview
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 participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
127 participants
Primary outcome timeframe
From baseline (day 0) to end of treatment (up to day 364)
Results posted on
2013-05-22
Participant Flow
The participants were recruited from 9 sites in Korea. All participants had completed the 7-month main study (CS42, NCT01071915) prior to enrollment into this extension study (CS42A). The CS42A study was conducted between 20 September 2010 (FPFV) and 25 April 2012 (LPLV).
Participant milestones
| Measure |
Degarelix
80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
|
|---|---|
|
Overall Study
STARTED
|
157
|
|
Overall Study
CS42 and CS42A Safety Analysis Set
|
156
|
|
Overall Study
CS42 and CS42A Full Analysis Set
|
155
|
|
Overall Study
CS42A Safety Analysis Set
|
127
|
|
Overall Study
COMPLETED
|
112
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Degarelix
80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
|
|---|---|
|
Overall Study
Not completed CS42
|
9
|
|
Overall Study
Not enrolled from CS42 to CS42A
|
21
|
|
Overall Study
Adverse event (CS42A)
|
2
|
|
Overall Study
Physician decision (CS42A)
|
6
|
|
Overall Study
Withdrawal by subject (CS42A)
|
5
|
|
Overall Study
Miscellaneous reasons (CS42A)
|
2
|
Baseline Characteristics
Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients
Baseline characteristics by cohort
| Measure |
Degarelix
n=156 Participants
80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
|
|---|---|
|
Age Continuous
|
72.6 years
STANDARD_DEVIATION 8.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
156 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline (day 0) to end of treatment (up to day 364)Population: Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).
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 participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal
Outcome measures
| Measure |
Degarelix
n=156 Participants
80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
|
|---|---|
|
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-Cholesterol (mmol/L) >=8.0
|
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-Total bilirubin (micromol/L) >1.5xULN
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
S-Urea nitrogen (mmol/L) >=10.7
|
10 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-Basophils (%) >=5
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-Eosinophils (%) >=10
|
7 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-Haematocrit (ratio) <=0.37
|
83 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-Haemoglobin (g/L) <=115
|
9 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-Neutrophils (%) >=90
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
B-Red blood cell count (10^12/L) <=3.5
|
25 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
|
PRIMARY outcome
Timeframe: From baseline (day 0) to end of treatment (up to day 364)Population: Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Outcome measures
| Measure |
Degarelix
n=156 Participants
80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
|
|---|---|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Diastolic blood pressure <=50 and decrease >=15
|
13 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
|
20 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
Pulse rate <=50 and decrease >=15
|
10 Participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Pulse 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% from baseline
|
4 Participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Body weight increase of >=7% from baseline
|
12 Participants
|
PRIMARY outcome
Timeframe: From baseline (day 0) to end of treatment (up to day 364)Population: Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).
This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Outcome measures
| Measure |
Degarelix
n=156 Participants
80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
|
|---|---|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
PR interval (msec) <=120
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
PR interval (msec) >=220
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QRS interval (msec) >=120
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QT interval (msec) >=450
|
27 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QT interval (msec) >=480
|
6 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QT interval (msec) >=500
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QT interval increase of >=30 from baseline
|
69 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QT interval increase of >=60 from baseline
|
20 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QTcF (msec) >=450
|
25 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QTcF (msec) >=480
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QTcF (msec) >=500
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QTcF increase of >=30 from baseline
|
39 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
QTcF increase of >=60 from baseline
|
8 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
Ventricular rate (beats/min) <=50
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values in ECG Variables
Ventricular rate (beats/min) >=120
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 0, day 196, day 280, and day 364Population: CS42 and CS42A full analysis set (data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing). The figures present the median of the absolute values at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).
PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).
Outcome measures
| Measure |
Degarelix
n=155 Participants
80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
|
|---|---|
|
Serum Levels of Prostate Specific Antigen (PSA) Over Time
Day 196
|
0.67 ng/mL
Interval 0.1 to 100.0
|
|
Serum Levels of Prostate Specific Antigen (PSA) Over Time
Day 280
|
0.52 ng/mL
Interval 0.1 to 100.0
|
|
Serum Levels of Prostate Specific Antigen (PSA) Over Time
Day 364
|
0.46 ng/mL
Interval 0.1 to 100.0
|
|
Serum Levels of Prostate Specific Antigen (PSA) Over Time
Baseline (Day 0)
|
19.2 ng/mL
Interval 1.59 to 100.0
|
Adverse Events
Degarelix
Serious events: 25 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix
n=156 participants at risk
80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Cardiac disorders
Angina unstable
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Eye disorders
Diabetic retinopathy
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Eye disorders
Hypermetropia
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
General disorders
Asthenia
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
General disorders
Disease progression
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
General disorders
Sudden death
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Infections and infestations
Appendicitis
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Infections and infestations
Herpes zoster
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Infections and infestations
Influenza
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.3%
2/156 • Number of events 2 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to prostate
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Nervous system disorders
Dizziness
|
0.64%
1/156 • Number of events 2 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Nervous system disorders
Paraplegia
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Nervous system disorders
Spinal cord compression
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Renal and urinary disorders
Dysuria
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Renal and urinary disorders
Haematuria
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Renal and urinary disorders
Urinary retention
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Reproductive system and breast disorders
Penile pain
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Surgical and medical procedures
Ureteral stent removal
|
0.64%
1/156 • Number of events 1 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
Other adverse events
| Measure |
Degarelix
n=156 participants at risk
80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
|
|---|---|
|
General disorders
Injection site pain
|
25.0%
39/156 • Number of events 55 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.2%
19/156 • Number of events 21 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.0%
14/156 • Number of events 16 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
13/156 • Number of events 13 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
General disorders
Injection site erythema
|
8.3%
13/156 • Number of events 13 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
11/156 • Number of events 15 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Nervous system disorders
Dizziness
|
7.1%
11/156 • Number of events 13 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Renal and urinary disorders
Nocturia
|
7.1%
11/156 • Number of events 11 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Nervous system disorders
Headache
|
6.4%
10/156 • Number of events 13 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Renal and urinary disorders
Pollakiuria
|
5.8%
9/156 • Number of events 10 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
8/156 • Number of events 10 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
|
Psychiatric disorders
Insomnia
|
5.1%
8/156 • Number of events 9 • From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
|
Additional Information
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.
- Publication restrictions are in place
Restriction type: OTHER