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    Clinical Trial Results:
    Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG Score changes during initiation of Androgen Deprivation Therapy (ADT) with triptorelin (22.5 mg) in patients with advanced prostate cancer (PCa): A phase III, single arm multicentre study

    Summary
    EudraCT number
    		 2009-012786-58
    Trial protocol
    		 GB   ES   LV   FR   NL   LT   BE   IT  
    Global end of trial date
    28 Jun 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 Feb 2016
    First version publication date
    03 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review and correction.

    Trial information

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    Trial identification
    Sponsor protocol code
    8-79-52014-168
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01020448
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma sas
    Sponsor organisation address
    65, quai Georges Gorse, Boulogne-Billancourt, France, F-92100
    Public contact
    Medical Director, Oncology, Ipsen Pharma sas, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Oncology, Ipsen Pharma sas, clinical.trials@ipsen.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
    06 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To model the PCA-3 change at Month 6 (M6) post treatment assessment.
    Protection of trial subjects
    In compliance with Good Clinical Practice (GCP), the medical records/medical notes etc. had to be clearly marked and permit easy identification of a patient’s participation in the specified clinical trial. The dose of triptorelin sustained release (SR) 22.5 mg used in this study has been previously investigated in a multicentre, non-comparative phase III study in patients with advanced PCa.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 14
    Country: Number of subjects enrolled
    Romania: 34
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    United Kingdom: 51
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Denmark: 24
    Country: Number of subjects enrolled
    France: 89
    Country: Number of subjects enrolled
    Latvia: 26
    Country: Number of subjects enrolled
    Lithuania: 41
    Worldwide total number of subjects
    325
    EEA total number of subjects
    325
    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)
    60
    From 65 to 84 years
    245
    85 years and over
    20

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study Initiation Date: 30-Nov-2009. Subjects screened were 339 and screen failures were 13.

    Pre-assignment
    Screening details
    		 326 of the 339 patients screened for this study were included; one patient was excluded from the safety population as no post-baseline assessment was available. The other 325 patients were included in the treatment group.

    Period 1
    Period 1 title
    Triptorelin (Decapeptyl®) 22.5 mg (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Triptorelin (Decapeptyl®) 22.5 mg
    Arm description
    		 Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triptorelin (Decapeptyl®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.

    Number of subjects in period 1
    		Triptorelin (Decapeptyl®) 22.5 mg
    Started
    325
    Completed
    299
    Not completed
    26
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    11
         Lost to follow-up
    2
         Disease Progression
    2
         Lack of efficacy
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Triptorelin (Decapeptyl®) 22.5 mg
    Reporting group description
    		 -

    Reporting group values
    		 Triptorelin (Decapeptyl®) 22.5 mg Total
    Number of subjects
    		 325 325
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 60 60
        From 65-84 years
    		 245 245
        85 years and over
    		 20 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.6 ( 8.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 325 325
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 7 7
        White
    		 307 307
        More than one race
    		 0 0
        Unknown or Not Reported
    		 10 10
    PCA-3 Score
    PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 • Non-assessable = Associated PSA mRNA <7500 copies/mL • ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL • <35 = PCA-3 mRNA above BLQ and less than 35 • ≥35 = PCA-3 mRNA greater or equal to 35
    Units: Subjects
        Non-assessable
    		 39 39
        ≤BLQ
    		 15 15
        <35
    		 89 89
        ≥35
    		 179 179
        Missing - No sample analysis done
    		 3 3
    Height
    n=315, missing=10
    Units: Cm
        arithmetic mean (standard deviation)
    		 172.3 ( 6.5 ) -
    Weight
    n=317, missing=8
    Units: KG
        arithmetic mean (standard deviation)
    		 79.6 ( 13.4 ) -
    BMI
    n=314, missing=11
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 26.79 ( 4.23 ) -

    End points

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    End points reporting groups
    Reporting group title
    Triptorelin (Decapeptyl®) 22.5 mg
    Reporting group description
    		 Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.

    Primary: PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA

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    End point title
    		 PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA [1]
    End point description
    PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 • Non-assessable = Associated PSA mRNA <7500 copies/mL • ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL • <35 = PCA-3 mRNA above BLQ and less than 35 • ≥35 = PCA-3 mRNA greater or equal to 35 Number of participants analyzed were 298 as one participant was admitted to an asylum and was withdrawn before month 1 visit was scheduled. No postbaseline assessment was available for this patient.
    End point type
    Primary
    End point timeframe
    At month 6 post-treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis for this endpoint
    End point values
    		 Triptorelin (Decapeptyl®) 22.5 mg
    Number of subjects analysed
    298
    Units: Number of subjects analysed
        Non-assessable
    232
        ≤BLQ
    27
        <35
    10
        ≥35
    24
        Missing - No sample analysis done
    5
    No statistical analyses for this end point

    Secondary: PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA

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    End point title
    		 PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA
    End point description
    PCA-3 score = (mRNA PCA3/mRNA PSA)x1000 • Non-assessable = Associated PSA mRNA <7500 copies/mL • ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL • <35 = PCA-3 mRNA above BLQ and less than 35 • ≥35 = PCA-3 mRNA greater or equal to 35 Analysis based on number (N) of patients with a valid value. Intention-to-treat (ITT) population.
    End point type
    Secondary
    End point timeframe
    At month 1 and 3 post-treatment
    End point values
    		 Triptorelin (Decapeptyl®) 22.5 mg
    Number of subjects analysed
    322
    Units: Number of Participants
        Month 1: Non-assessable (N=322)
    109
        Month 1: ≤BLQ (N=322)
    40
        Month 1: <35 (N=322)
    80
        Month 1: ≥35 (N=322)
    91
        Month 1: Missing-No sample analysis done (N=322)
    2
        Month 3: Non-assessable (N=313)
    215
        Month 3: ≤BLQ (N=313)
    31
        Month 3: <35 (N=313)
    34
        Month 3: ≥35 (N=313)
    31
        Month 3: Missing-No sample analysis done (N=313)
    2
    No statistical analyses for this end point

    Secondary: TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)

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    End point title
    		 TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)
    End point description
    TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000 A TMPRSS2-ERG score <35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.' Analysis based on number (N) of patients with a valid value. ITT population.
    End point type
    Secondary
    End point timeframe
    At baseline, month 1, 3 and 6 post-treatment
    End point values
    		 Triptorelin (Decapeptyl®) 22.5 mg
    Number of subjects analysed
    322
    Units: Number of subjects
        Baseline: Non-assessable (N=322)
    33
        Baseline: <35 negative (N=322)
    140
        Baseline: ≥35 positive (N=322)
    149
        Month 1: Non-assessable (N=322)
    117
        Month 1: <35 negative (N=322)
    97
        Month 1: ≥35 positive (N=322)
    106
        Month 1: Missing-No sample analysis done (N=322)
    2
        Month 3: Non-assessable (N=313)
    213
        Month 3: <35 negative (N=313)
    45
        Month 3: ≥35 positive (N=313)
    53
        Month 3: Missing-No sample analysis done (N=313)
    2
        Month 6: Non-assessable (N=298)
    241
        Month 6: <35 negative (N=298)
    24
        Month 6: ≥35 positive (N=298)
    27
        Month 6: Missing-No sample analysis done (N=298)
    6
    No statistical analyses for this end point

    Secondary: Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)

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    End point title
    		 Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)
    End point description
    Analysis based on number (N) of patients with a valid value. ITT population.
    End point type
    Secondary
    End point timeframe
    At month 1, 3 and 6 post-treatment
    End point values
    		 Triptorelin (Decapeptyl®) 22.5 mg
    Number of subjects analysed
    322
    Units: Percentage of participants
    number (not applicable)
        Month 1 (N=322)
    94.7
        Month 3 (N=313)
    95.2
        Month 6 (N=298)
    90.9
    No statistical analyses for this end point

    Secondary: PSA Level

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    End point title
    		 PSA Level
    End point description
    Analysis based on number (N) of patients with a valid value. ITT population.
    End point type
    Secondary
    End point timeframe
    At baseline, month 1, 3 and 6 post-treatment
    End point values
    		 Triptorelin (Decapeptyl®) 22.5 mg
    Number of subjects analysed
    322
    Units: μg/L
    median (full range (min-max))
        Baseline (N=321)
    45.4 (1 to 12239)
        Month 1 (N=320)
    8.3 (0 to 581)
        Month 3 (N=311)
    1.8 (0 to 969)
        Month 6 (N=296)
    1.2 (0 to 1251)
    No statistical analyses for this end point

    Secondary: Safety, Assessed Through the Collection of Adverse Events (AEs)

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    End point title
    		 Safety, Assessed Through the Collection of Adverse Events (AEs)
    End point description
    End point type
    Secondary
    End point timeframe
    For the duration of the study (up to month 6)
    End point values
    		 Triptorelin (Decapeptyl®) 22.5 mg
    Number of subjects analysed
    325
    Units: Number of subjects
        Any Adverse Events (AEs)
    193
        Any Treatment Emergent Adverse Events (TEAEs)
    190
        TEAEs Leading to Withdrawal
    11
        TEAEs Leading to Death
    11
        Serious Adverse Events (SAEs)
    37
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to month 6
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Triptorelin (Decapeptyl®) 22.5 mg
    Reporting group description
    		 Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.

    Serious adverse events
    		 Triptorelin (Decapeptyl®) 22.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 325 (11.38%)
         number of deaths (all causes)
    11
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bone pain due to metastasis
         subjects affected / exposed
    2 / 325 (0.62%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Rectum tumor
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Larynx adenocarcinoma
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cancer progression
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Urothelial tumor in the bladder
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Right central pulmonary tumor malignant
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Claudication
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blocked nephrostomy catheter
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic venous thrombophlebitis
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Unspecific thoracic pain
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thoracic pain
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Allergy to conc med
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Hemorrhage prostate
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bilateral pleural effusion
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Right pleurisy
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Investigations
    Weight gain
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Deliberate medication overdose
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    2 / 325 (0.62%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardio respiratory arrest
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Heart failure
         subjects affected / exposed
    3 / 325 (0.92%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Chronic heart failure
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Paraplegia
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Severe anemia
         subjects affected / exposed
    2 / 325 (0.62%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fecal peritonitis
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Entero-cutaneous fistula
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Perforated colon
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Perforated gall bladder
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Right inguinal hernia
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Liver failure
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Heamaturia
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute renal failure
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    End stage renal failure
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    4 / 325 (1.23%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urethral stricture
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Increased pain in right thigh
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Worsening of chronic lumbago
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Chest infection
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis acute
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute pneumonia
         subjects affected / exposed
    2 / 325 (0.62%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Pneumonia pneumocystis
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septicaemia
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septicemia due to catheter
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypocalcemia
         subjects affected / exposed
    1 / 325 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Triptorelin (Decapeptyl®) 22.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    89 / 325 (27.38%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    89 / 325 (27.38%)
         occurrences all number
    89

    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.
    None reported
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