Trial Outcomes & Findings for GP Extended Action Triptorelin (NCT NCT01673984)
NCT ID: NCT01673984
Last Updated: 2025-05-23
Results Overview
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
6 months
Results posted on
2025-05-23
Participant Flow
35 subjects screened and 27 subjects were enrolled. Following enrollment, 21 patients were randomised before the study was prematurely discontinued.
Participant milestones
| Measure |
Decapeptyl® SR 22.5mg
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
7
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
Decapeptyl® SR 22.5mg
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Study termination
|
9
|
6
|
Baseline Characteristics
GP Extended Action Triptorelin
Baseline characteristics by cohort
| Measure |
Decapeptyl® SR 22.5mg
n=14 Participants
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
n=7 Participants
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.2 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
78.7 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
77.7 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Employment status/Occupation
Employed
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Employment status/Occupation
Retired
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Analysis based on intent-to-treat (ITT) population comprised of 21 patients.
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
Outcome measures
| Measure |
Decapeptyl® SR 22.5mg
n=14 Participants
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
n=7 Participants
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Percentage of Participants Maintaining Biochemical Castration
|
92.9 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis based on the number of subjects with a valid value in the ITT population comprised of 21 patients.
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..
Outcome measures
| Measure |
Decapeptyl® SR 22.5mg
n=9 Participants
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
n=4 Participants
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.
|
22.2 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population which comprised of 21 patients.
Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.
Outcome measures
| Measure |
Decapeptyl® SR 22.5mg
n=13 Participants
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
n=7 Participants
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels
6 months (n = 13, 7)
|
84.6 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels
12 months (n = 2, 1)
|
50 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.
The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).
Outcome measures
| Measure |
Decapeptyl® SR 22.5mg
n=3 Participants
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
n=2 Participants
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.
|
71.7 units on a scale
Interval 40.4 to 102.9
|
70.0 units on a scale
Interval -57.1 to 197.1
|
SECONDARY outcome
Timeframe: 6 and 12 monthPopulation: Analysis based on the number (n) of subjects with a valid value in each arm of the ITT population which comprised of 21 patients.
TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.
Outcome measures
| Measure |
Decapeptyl® SR 22.5mg
n=14 Participants
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
n=7 Participants
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Baseline to 6 months - Effectiveness (n= 13, 7)
|
3.2 units on a scale
Interval -12.5 to 18.9
|
13.1 units on a scale
Interval -10.8 to 37.0
|
|
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Baseline to 12 months - Effectiveness (n= 3, 2)
|
-33.3 units on a scale
Interval -74.7 to 8.1
|
-12.5 units on a scale
Interval -383.1 to 358.1
|
|
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Baseline to 6 months - Side Effects (n= 13, 7)
|
-2.6 units on a scale
Interval -12.9 to 7.8
|
4.8 units on a scale
Interval -6.0 to 15.5
|
|
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Baseline to 12 months - Side Effects (n= 3, 2)
|
-25.0 units on a scale
Interval -115.2 to 65.2
|
12.5 units on a scale
Interval -146.3 to 171.3
|
|
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Baseline to 6 months - Convenience (n= 13, 7)
|
4.7 units on a scale
Interval -6.3 to 15.7
|
2.0 units on a scale
Interval -9.8 to 13.7
|
|
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Baseline to 12 months - Convenience (n= 3, 2)
|
-1.9 units on a scale
Interval -36.6 to 32.9
|
2.8 units on a scale
Interval -103.1 to 108.7
|
|
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Baseline to 6months -Global Satisfaction(n= 12, 6)
|
-0.7 units on a scale
Interval -15.9 to 14.5
|
-4.2 units on a scale
Interval -11.5 to 3.2
|
|
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
Baseline to 12months -Global Satisfaction(n= 2, 2)
|
-12.5 units on a scale
Interval -171.3 to 146.3
|
4.2 units on a scale
Interval -48.8 to 57.1
|
SECONDARY outcome
Timeframe: Month 12Population: No participant analysis as no data was collected due to low number of participants recruited in the study.
Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Population: Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.
Outcome measures
| Measure |
Decapeptyl® SR 22.5mg
n=5 Participants
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
n=3 Participants
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Percentage of Participants Who Changed Injection Frequency After Completion of the Study
|
80 percentage of participants
|
0 percentage of participants
|
Adverse Events
Decapeptyl® SR 22.5mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Current 3-monthly LHRH Agonist
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decapeptyl® SR 22.5mg
n=14 participants at risk
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
n=7 participants at risk
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
General disorders
Disease progression
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
Other adverse events
| Measure |
Decapeptyl® SR 22.5mg
n=14 participants at risk
Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).
|
Current 3-monthly LHRH Agonist
n=7 participants at risk
One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Cardiac disorders
Bundle branch block right
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Ear and labyrinth disorders
Deafness
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Eye disorders
Cataract
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Colitis microscopic
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Glossodynia
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Oesophagitis
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
General disorders
Gait disturbance
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
General disorders
Oedema peripheral
|
14.3%
2/14 • Number of events 2 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
General disorders
Suprapubic pain
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
Ear infection
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Eye infection bacterial
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Urinary tract infection
|
14.3%
2/14 • Number of events 2 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Viral infection
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Laceration
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Investigations
Haemoglobin decreased
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Investigations
Serum ferritin increased
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
3/14 • Number of events 3 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Nervous system disorders
Dizziness
|
35.7%
5/14 • Number of events 5 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Nervous system disorders
Hemiparesis
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Nervous system disorders
Sciatica
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Renal and urinary disorders
Dysuria
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Renal and urinary disorders
Haematuria
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Renal and urinary disorders
Micturition urgency
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Reproductive system and breast disorders
Penile pain
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Reproductive system and breast disorders
Prostatitis
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
14.3%
2/14 • Number of events 2 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.4%
3/14 • Number of events 3 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
2/14 • Number of events 2 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Vascular disorders
Hot flush
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Vascular disorders
Peripheral vascular disorder
|
7.1%
1/14 • Number of events 1 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/14 • Up to 12 months
|
14.3%
1/7 • Number of events 1 • Up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place