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    Clinical Trial Results:
    A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

    Summary
    EudraCT number
    		 2017-002495-20
    Trial protocol
    		 SK   CZ   DE   GB   FR   GR   FI   PL  
    Global end of trial date
    29 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2022
    First version publication date
    06 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    000108
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02663908
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ferring Pharmaceuticals A/S
    Sponsor organisation address
    International PharmaScience Center, Amager Strandvej 405, Kastrup, Denmark, 2770
    Public contact
    Global Clinical Compliance, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Scientific contact
    Global Clinical Compliance, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the effect of a gonadotropin-releasing hormone (GnRH) receptor antagonist (degarelix) on the risk of occurrence of major adverse cardiovascular events (MACEs) (a composite of death due to any cause, non-fatal myocardial infarction or non-fatal stroke) as compared to a GnRH receptor agonist (leuprolide) in subjects with prostate cancer and concomitant cardiovascular disease (CVD).
    Protection of trial subjects
    The trial was performed in compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Good Clinical Practice (GCP).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Apr 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Slovakia: 82
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Czechia: 47
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    France: 30
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Greece: 30
    Country: Number of subjects enrolled
    Canada: 51
    Country: Number of subjects enrolled
    United States: 213
    Country: Number of subjects enrolled
    South Africa: 2
    Country: Number of subjects enrolled
    Russian Federation: 47
    Worldwide total number of subjects
    545
    EEA total number of subjects
    217
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    64
    From 65 to 84 years
    450
    85 years and over
    31

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was performed at 113 investigational sites in 12 countries between Apr 2016 to Mar 2021.

    Pre-assignment
    Screening details
    		 In total, 702 subjects were screened of which 545 subjects were randomised. Of the randomised subjects, 544 subjects were exposed to investigational medicinal product (IMP): 275 to Degarelix and 269 to Leuprolide. One subject was randomised in error and was not exposed to IMP.

    Period 1
    Period 1 title
    Randomised Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    A true double-blind design was considered difficult to apply, most importantly because of factors such as different doses and treatment regimens as well as expected differences in incidence of injection-site reactions. Instead, an assessor-blinded design was applied.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Degarelix 240 mg/80 mg
    Arm description
    		 Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two subcutaneous (SC) depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Degarelix 240 mg/80 mg
    Investigational medicinal product code
    Other name
    FIRMAGON
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two subcutaneous (SC) depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.

    Arm title
    		 Leuprolide 22.5 mg
    Arm description
    		 Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Leuprolide 22.5 mg
    Investigational medicinal product code
    Other name
    LUPRON DEPOT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: A true double-blind design was considered difficult to apply, most importantly because of factors such as different doses and treatment regimens as well as expected differences in incidence of injection-site reactions. Instead, an assessor-blinded design was implemented.
    Number of subjects in period 1 [2]
    		Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Started
    275
    269
    Completed
    244
    245
    Not completed
    31
    24
         Consent withdrawn by subject
    8
    5
         Lack of therapeutic response
    2
    -
         Adverse event, non-fatal
    13
    11
         Protocol violation
    1
    2
         COVID-19
    1
    -
         Death
    1
    -
         Subject discontinued treatment
    -
    1
         Subject ended trial (prohibited medication)
    1
    -
         Intolerance to FIRMAGON therapy
    1
    -
         Site closed
    1
    -
         Lost to follow-up
    1
    5
         Subject treated with an exclusionary medication
    1
    -
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In total, 702 subjects were screened of which 545 subjects were randomised. Of the randomised subjects, 544 subjects were exposed to the IMP: 275 to Degarelix and 269 to Leuprolide. One subject was randomised in error and did not receive the IMP.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Degarelix 240 mg/80 mg
    Reporting group description
    		 Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two subcutaneous (SC) depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.

    Reporting group title
    Leuprolide 22.5 mg
    Reporting group description
    		 Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.

    Reporting group values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg Total
    Number of subjects
    		 275 269 544
    Age categorical
    Units: Subjects
        < 75 years
    		 153 151 304
        >= 75 years
    		 122 118 240
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.3 ± 7.28 73.1 ± 7.16 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 275 269 544
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 16 14 30
        Not Hispanic or Latino
    		 256 254 510
        Unknown or Not Reported
    		 3 1 4
    Stage of prostate cancer
    Units: Subjects
        Localised
    		 138 133 271
        Locally Advanced
    		 63 80 143
        Metastatic
    		 63 48 111
        Not classifiable
    		 11 8 19
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 2
        Asian
    		 3 5 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 16 12 28
        White
    		 252 251 503
        Unknown or Not Reported
    		 2 1 3
    Eastern Cooperative Oncology Group (ECOG) performance score
    Units: Subjects
        0 score
    		 178 167 345
        1 score
    		 75 80 155
        2 score
    		 8 11 19
        Unknown or Not Reported
    		 14 11 25
    Baseline body mass index (BMI)
    Degarelix 240 mg/80 mg: n=273; Leuprolide 22.5 mg: n=268
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 28.38 ± 5.057 28.58 ± 4.589 -
    Testosterone levels
    Degarelix 240 mg/80 mg: n=274
    Units: ng/dL
        arithmetic mean (standard deviation)
    		 353.6 ± 150.49 351.6 ± 140.32 -
    Prostate Specific Antigen (PSA)
    Leuprolide 22.5 mg: n=268
    Units: ng/mL
        arithmetic mean (standard deviation)
    		 119.7 ± 472.10 59.9 ± 236.68 -

    End points

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    End points reporting groups
    Reporting group title
    Degarelix 240 mg/80 mg
    Reporting group description
    		 Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two subcutaneous (SC) depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.

    Reporting group title
    Leuprolide 22.5 mg
    Reporting group description
    		 Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS consisted of all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.

    Primary: Time From Randomisation to the First Confirmed (Adjudicated) Occurrence of the Composite MACE Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial

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    End point title
    		 Time From Randomisation to the First Confirmed (Adjudicated) Occurrence of the Composite MACE Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial
    End point description
    Composite MACE endpoint was defined as: death due to any cause, non-fatal myocardial infarction or non-fatal stroke. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) occurrence of composite MACE over time. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Primary
    End point timeframe
    Randomisation to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: percentage of subjects
        number (not applicable)
    5.5
    4.1
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5294 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.283
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.589
         upper limit
    		 2.794
    Notes
    [1] - The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.

    Secondary: Time From Randomisation to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction, Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial

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    End point title
    		 Time From Randomisation to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction, Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial
    End point description
    Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) occurrence of CV-related death, non-fatal myocardial infarction, non-fatal stroke. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Randomisation to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: percentage of subjects
        number (not applicable)
    3.3
    2.6
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7126
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.204
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.448
         upper limit
    		 3.234

    Secondary: Time From Randomisation to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial

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    End point title
    		 Time From Randomisation to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial
    End point description
    Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) CV-related death. Percentage of observed subjects with outcome measure events during the trial are reported. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Randomisation to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: percentage of subjects
        number (not applicable)
    0.4
    1.9
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0853
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.186
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.022
         upper limit
    		 1.595

    Secondary: Time From Randomisation to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial

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    End point title
    		 Time From Randomisation to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial
    End point description
    Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) myocardial infarction. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Randomisation to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: percentage of subjects
        number (not applicable)
    1.8
    1.1
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5196
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.594
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.381
         upper limit
    		 6.673

    Secondary: Time From Randomisation to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial

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    End point title
    		 Time From Randomisation to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial
    End point description
    Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) stroke. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Randomisation to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: percentage of subjects
        number (not applicable)
    1.1
    1.1
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8966
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.899
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.181
         upper limit
    		 4.457

    Secondary: Time From Randomisation to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalisation; Percentage of Observed Subjects With Outcome Measure Events During the Trial

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    End point title
    		 Time From Randomisation to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalisation; Percentage of Observed Subjects With Outcome Measure Events During the Trial
    End point description
    Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) unstable angina requiring hospitalisation. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Randomisation to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: percentage of subjects
        number (not applicable)
    0.7
    1.5
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3857
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.088
         upper limit
    		 2.62

    Secondary: Time From Randomisation to Death Due to Any Cause; Percentage of Observed Subjects With Outcome Measure Events During the Trial

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    End point title
    		 Time From Randomisation to Death Due to Any Cause; Percentage of Observed Subjects With Outcome Measure Events During the Trial
    End point description
    Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict death due to any cause. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Randomisation to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: percentage of subjects
        number (not applicable)
    2.9
    3.3
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.718
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.839
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.324
         upper limit
    		 2.176

    Secondary: Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide treatment groups

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    End point title
    		 Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide treatment groups
    End point description
    Median levels and interquartile ranges for serum testosterone at Days 28, 168, and 336 are presented. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Days 28, 168 and 336 (end-of-trial) Degarelix 240 mg/80 mg: Day 28 (n=264) , Day 168 (n=247) , Day 336 (n=234) Leuprolide 22.5 mg: Day 28 (n=257) , Day 168 (n=248) , Day 336 (n=228)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: ng/dL
    median (inter-quartile range (Q1-Q3))
        Day 28
    8.650 (6.810 to 13.960)
    14.410 (10.910 to 20.170)
        Day 168
    8.650 (5.760 to 12.750)
    8.475 (5.760 to 11.530)
        Day 336
    9.855 (5.760 to 14.410)
    8.650 (5.760 to 11.530)
    No statistical analyses for this end point

    Secondary: Time From Randomisation to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial

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    End point title
    		 Time From Randomisation to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial
    End point description
    Time to failure in PFS was defined as the time, measured in days, from randomisation to the first occurrence of either death, radiographic disease progression, introduction of additional prostate cancer therapies for progression, or PSA failure. Subjects who discontinued treatment with IMP or withdrew from the trial were censored at the time of discontinuation/withdrawal. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict failure in PFS. Percentage of observed subjects with outcome measure events during the trial are reported. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    From randomisation to end-of-trial for each subject (subjects not censored at Day 336)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: percentage of subjects
        number (not applicable)
    8.7
    10.0
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6701
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.887
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.512
         upper limit
    		 1.539

    Secondary: Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores

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    End point title
    		 Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores
    End point description
    Lower urinary tract symptoms were measured with the IPSS Version 1 (IPSS-1). The IPSS is a subject-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question was assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS-1 score was then calculated as summation over the responses for all 7 questions. The total IPSS-1 score was transformed to a scale from 0 (lowest score) to 100 (highest score). Higher scores reflect higher severity of symptoms. The IPSS-1 included an additional single question to assess a subject’s QoL in relation to his urinary symptoms; response to this question was analysed separately and was not included in the total IPSS score. The score was similarly scaled from 0 to 100. Change from baseline in IPSS Total and QoL scores are presented.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 168 and 336 (end-of-trial) Degarelix: 240 mg/80 mg: Day 168 (n=234), Day 336 (n=195) Leuprolide 22.5 mg: Day 168 (n=232), Day 336 (n=191)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    234
    232
    Units: score on a scale
    least squares mean (confidence interval 95%)
        IPSS Total at Day 168
    -0.000 (-0.804 to 0.804)
    0.907 (0.098 to 1.715)
        IPSS, QoL at Day 168
    -0.115 (-0.298 to 0.068)
    0.098 (-0.086 to 0.282)
        IPSS Total at Day 336
    -0.795 (-1.619 to 0.029)
    0.121 (-0.712 to 0.953)
        IPSS, QoL at Day 336
    -0.281 (-0.467 to -0.095)
    -0.234 (-0.422 to -0.046)
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    IPSS Total at Day 168
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1193
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -0.907
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.048
         upper limit
    		 0.235
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    IPSS, QoL at Day 168
    Comparison groups
    Leuprolide 22.5 mg v Degarelix 240 mg/80 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.108
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -0.213
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.473
         upper limit
    		 0.047
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    IPSS Total at Day 336 n=386
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1256
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.916
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.089
         upper limit
    		 0.257
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    IPSS, QoL at Day 336 n=386
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7261
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.047
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.312
         upper limit
    		 0.218

    Secondary: Total Number of CV-related Hospitalisation Events Over the Duration of the Trial

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    End point title
    		 Total Number of CV-related Hospitalisation Events Over the Duration of the Trial
    End point description
    The total number of CV-related hospitalisations over the duration of the trial was defined as the number of hospitalisations due to CV-related adverse events, observed from the first exposure to IMP up until Day 336 for each subject.
    End point type
    Secondary
    End point timeframe
    First dose of IMP to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: Number of events
    number (not applicable)
        Subjects with events
    12
    14
        Events
    15
    17
    No statistical analyses for this end point

    Secondary: Total Number of Coronary Artery By-pass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) Procedures Over the Duration of the Trial

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    End point title
    		 Total Number of Coronary Artery By-pass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) Procedures Over the Duration of the Trial
    End point description
    The total number of CABG or PCI procedures observed for each subject over the duration of the trial
    End point type
    Secondary
    End point timeframe
    First dose of IMP to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: Number of events
    number (not applicable)
        Subjects with events
    2
    4
        Events
    3
    6
    No statistical analyses for this end point

    Secondary: Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial

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    End point title
    		 Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial
    End point description
    CV-related ER visit events (that did not lead to hospitalisation) was observed from the first exposure to IMP up until Day 336 for each subject.
    End point type
    Secondary
    End point timeframe
    First dose of IMP to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: Number of events
    number (not applicable)
        Subjects with events
    8
    2
        Events
    8
    2
    No statistical analyses for this end point

    Secondary: Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)

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    End point title
    		 Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)
    End point description
    The EQ-5D-5L essentially consists of 2 systems - the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS is an overall estimation of the present health status. The results from the EQ-5D-5L questionnaire were converted into quality adjusted life year (QALY) units. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    243
    239
    Units: QALY
        least squares mean (confidence interval 95%)
    0.794 (0.770 to 0.818)
    0.796 (0.772 to 0.820)
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    482
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.911
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -0.002
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.036
         upper limit
    		 0.032

    Secondary: Changes From Baseline in Duke Activity Status Index (DASI) Global Score

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    End point title
    		 Changes From Baseline in Duke Activity Status Index (DASI) Global Score
    End point description
    The DASI is a self-administered instrument developed to measure functional capacity in subjects with CVD. It contains 12 items referring to the present time, assessing the ability to perform physical tasks in five domains: personal care (1 item), ambulation (4 items), household tasks (4 items), sexual function (1 item) and recreation (2 items). Each question was answered by one of four options: ‘yes with no difficulty’ / ‘yes, but with some difficulty’ / ‘no, I can’t do this’ / ‘don’t do this for other reasons’. A global score was calculated with a higher score indicating a higher functional capacity. Change from baseline in DASI Global score is presented. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 168 and 336 (end-of-trial) Degarelix 240 mg/80 mg: Day 168 (n=234), Day 336 (n=195) Leuprolide 22.5 mg: Day 168 (n=232), Day 336 (n=191)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    234
    232
    Units: score on a scale
    least squares mean (confidence interval 95%)
        Change in DASI to Day 168
    -2.65 (-3.95 to -1.35)
    -1.08 (-2.38 to 0.23)
        Change in DASI to Day 336
    -2.18 (-3.54 to -0.81)
    -3.01 (-4.39 to -1.63)
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg Day 168
    Statistical analysis description
    DASI at Day 168
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0936
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.41
         upper limit
    		 0.27
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg Day 336
    Statistical analysis description
    DASI at Day 336 n=386
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.11
         upper limit
    		 2.78

    Secondary: Changes From Baseline in Cardiac Anxiety Questionnaire (CAQ) Global Score and Score Per Domain

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    End point title
    		 Changes From Baseline in Cardiac Anxiety Questionnaire (CAQ) Global Score and Score Per Domain
    End point description
    The CAQ is a self-administered questionnaire developed to measure heart-focused anxiety in persons with or without heart disease. It contains 18 items referring to the present time assessing cardiac anxiety in three domains: fear (8 items), avoidance (5 items) and attention (5 items). Each question was assigned a score between 0 “never” to 4 “always”. A global score and scores per domain was computed with higher score indicating greater cardiac anxiety. Change from baseline in CAQ Global score and score per domain are presented. The analysis population consisted of the FAS which comprised all randomised and treated subjects (who received at least one dose of IMP) and was analysed based on the planned (randomised) treatment.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 168 and 336 (end-of-trial) Degarelix 240 mg/80 mg: Day 168 (n=234), Day 336 (n=195) Leuprolide 22.5 mg: Day 168 (n=232), Day 336 (n=191)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    234
    232
    Units: score on a scale
    least squares mean (confidence interval 95%)
        CAQ Global Score (Day 168)
    0.034 (-0.021 to 0.088)
    -0.011 (-0.066 to 0.044)
        CAQ domain score for Attention (Day 168)
    0.030 (-0.034 to 0.094)
    -0.006 (-0.070 to 0.059)
        CAQ domain score for Avoidance (Day 168)
    0.155 (0.062 to 0.248)
    0.039 (-0.054 to 0.133)
        CAQ domain score for Fear (Day 168)
    -0.036 (-0.106 to 0.034)
    -0.048 (-0.119 to 0.022)
        CAQ Global Score (Day 336)
    0.102 (0.043 to 0.161)
    0.051 (-0.009 to 0.110)
        CAQ domain score for Attention (Day 336)
    0.023 (-0.046 to 0.092)
    -0.015 (-0.085 to 0.054)
        CAQ domain score for Avoidance (Day 336)
    0.228 (0.130 to 0.325)
    0.220 (0.122 to 0.319)
        CAQ domain score for Fear (Day 336)
    0.075 (-0.003 to 0.153)
    -0.018 (-0.097 to 0.061)
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    CAQ global score at Day 168
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2535
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    0.045
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.032
         upper limit
    		 0.122
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    CAQ domain score for Attention at Day 168
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.437
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    0.036
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.055
         upper limit
    		 0.127
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    CAQ domain score for Avoidance at Day 168
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0852
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    0.116
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.016
         upper limit
    		 0.248
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    CAQ domain score for Fear at Day 168
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8156
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    0.012
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.087
         upper limit
    		 0.111
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    CAQ Global Score at Day 336 n=386
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2299
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    0.051
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.033
         upper limit
    		 0.135
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    CAQ domain score for Attention at Day 336 n=386
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.444
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    0.038
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.136
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    CAQ domain score for Avoidance at Day 336 n=386
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9172
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    0.007
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.131
         upper limit
    		 0.146
    Statistical analysis title
    		 Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
    Statistical analysis description
    CAQ domain score for Fear at Day 336 n=386
    Comparison groups
    Degarelix 240 mg/80 mg v Leuprolide 22.5 mg
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1028
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    0.093
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.019
         upper limit
    		 0.204

    Secondary: Number of Subjects With Adverse Events (AEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs)
    End point description
    Adverse events were recorded from signed informed consent until end-of-trial. Adverse events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered ‘treatment-emergent’ and are presented for the safety analysis set. The analysis population consisted of safety analysis set which comprised all treated subjects (who received at least one dose of IMP) and was analysed based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Start of IMP treatment until 3 months after last dosing of IMP
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: subjects
    number (not applicable)
        AEs
    250
    228
        SAEs
    47
    44
        AE leading to death
    11
    9
    No statistical analyses for this end point

    Secondary: Intensity of AEs

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    End point title
    		 Intensity of AEs
    End point description
    The intensity of AE was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.02) 5-point scale and categorised as mild (grade 1), moderate (grade 2), and severe (grades 3, 4, and 5). The analysis population consisted of the safety analysis set which comprised all treated subjects (who received at least one dose of IMP) and was analysed based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Start of IMP treatment until 3 months after last dosing of IMP
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    275
    269
    Units: subjects
    number (not applicable)
        Mild AE
    224
    200
        Moderate AE
    160
    135
        Severe AE
    59
    55
    No statistical analyses for this end point

    Secondary: Changes in Vital Signs

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    End point title
    		 Changes in Vital Signs
    End point description
    Number of subjects shifting from normal value(s) in vital signs (pulse and blood pressure) at baseline to clinically significant abnormal value(s) at end-of-trial are presented. Note: Only subjects with appropriate baseline and post-baseline data are included in the evaluation. The analysis population consisted of the safety analysis set which comprised all treated subjects (who received at least one dose of IMP) and was analysed based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 336 (end-of-trial)
    End point values
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Number of subjects analysed
    196
    193
    Units: subjects
        number (not applicable)
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Start of IMP treatment until 3 months after last dosing of IMP
    Adverse event reporting additional description
    Adverse events were recorded from signed informed consent until end-of-trial. Events with onset after start of IMP, and within 3 months (3x28 days) after last dosing, were ‘treatment-emergent’ and presented (safety analysis set). Reporting exceptions: non-fatal serious myocardial infarction, stroke, and unstable angina (6 degarelix; 10 leuprolide).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Degarelix 240 mg/80 mg
    Reporting group description
    		 Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two subcutaneous (SC) depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.

    Reporting group title
    Leuprolide 22.5 mg
    Reporting group description
    		 Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.

    Serious adverse events
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    47 / 275 (17.09%)
    44 / 269 (16.36%)
         number of deaths (all causes)
    11
    9
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 275 (0.73%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 275 (0.00%)
    2 / 269 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    3 / 275 (1.09%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Malaise
         subjects affected / exposed
    1 / 275 (0.36%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site swelling
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    2 / 275 (0.73%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    1 / 275 (0.36%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 275 (0.00%)
    2 / 269 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 275 (0.73%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 275 (0.36%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Heart rate irregular
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 275 (0.73%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic ulcer haemorrhage
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure chronic
         subjects affected / exposed
    3 / 275 (1.09%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 275 (0.36%)
    2 / 269 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Atrial flutter
         subjects affected / exposed
    2 / 275 (0.73%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    2 / 275 (0.73%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 275 (0.73%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Angina pectoris
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 275 (0.00%)
    4 / 269 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 275 (0.36%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 275 (0.00%)
    3 / 269 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    2 / 275 (0.73%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 275 (0.36%)
    2 / 269 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    5 / 275 (1.82%)
    3 / 269 (1.12%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 275 (0.73%)
    3 / 269 (1.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 275 (0.73%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 275 (0.36%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic echinococciasis
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 275 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 275 (0.00%)
    2 / 269 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 275 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Degarelix 240 mg/80 mg Leuprolide 22.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    250 / 275 (90.91%)
    228 / 269 (84.76%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    107 / 275 (38.91%)
    120 / 269 (44.61%)
         occurrences all number
    112
    127
    Hypertension
         subjects affected / exposed
    17 / 275 (6.18%)
    23 / 269 (8.55%)
         occurrences all number
    27
    31
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    20 / 275 (7.27%)
    14 / 269 (5.20%)
         occurrences all number
    20
    16
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    50 / 275 (18.18%)
    34 / 269 (12.64%)
         occurrences all number
    57
    35
    Injection site pain
         subjects affected / exposed
    73 / 275 (26.55%)
    6 / 269 (2.23%)
         occurrences all number
    232
    7
    Injection site erythema
         subjects affected / exposed
    58 / 275 (21.09%)
    1 / 269 (0.37%)
         occurrences all number
    163
    1
    Injection site swelling
         subjects affected / exposed
    27 / 275 (9.82%)
    3 / 269 (1.12%)
         occurrences all number
    62
    3
    Asthenia
         subjects affected / exposed
    15 / 275 (5.45%)
    8 / 269 (2.97%)
         occurrences all number
    18
    9
    Oedema peripheral
         subjects affected / exposed
    8 / 275 (2.91%)
    15 / 269 (5.58%)
         occurrences all number
    8
    17
    Injection site induration
         subjects affected / exposed
    19 / 275 (6.91%)
    2 / 269 (0.74%)
         occurrences all number
    79
    3
    Pyrexia
         subjects affected / exposed
    16 / 275 (5.82%)
    5 / 269 (1.86%)
         occurrences all number
    20
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    23 / 275 (8.36%)
    26 / 269 (9.67%)
         occurrences all number
    26
    28
    Constipation
         subjects affected / exposed
    18 / 275 (6.55%)
    20 / 269 (7.43%)
         occurrences all number
    21
    20
    Nausea
         subjects affected / exposed
    19 / 275 (6.91%)
    11 / 269 (4.09%)
         occurrences all number
    21
    12
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    12 / 275 (4.36%)
    14 / 269 (5.20%)
         occurrences all number
    12
    14
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    24 / 275 (8.73%)
    28 / 269 (10.41%)
         occurrences all number
    25
    31
    Dysuria
         subjects affected / exposed
    25 / 275 (9.09%)
    21 / 269 (7.81%)
         occurrences all number
    27
    24
    Haematuria
         subjects affected / exposed
    8 / 275 (2.91%)
    15 / 269 (5.58%)
         occurrences all number
    17
    17
    Nocturia
         subjects affected / exposed
    8 / 275 (2.91%)
    14 / 269 (5.20%)
         occurrences all number
    8
    14
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    24 / 275 (8.73%)
    16 / 269 (5.95%)
         occurrences all number
    29
    17
    Back pain
         subjects affected / exposed
    22 / 275 (8.00%)
    19 / 269 (7.06%)
         occurrences all number
    25
    22
    Pain in extremity
         subjects affected / exposed
    15 / 275 (5.45%)
    11 / 269 (4.09%)
         occurrences all number
    19
    13
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    20 / 275 (7.27%)
    13 / 269 (4.83%)
         occurrences all number
    26
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial was originally planned to include approximately 900 patients but was stopped prematurely for feasibility reasons. The decision was not based on any safety concerns, any knowledge of the results, or issues imposed by the COVID-19 pandemic.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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