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    Clinical Trial Results:
    A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-Naive and Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients

    Summary
    EudraCT number
    2012-004331-23
    Trial protocol
    DE   BE   GB   IT   HU  
    Global end of trial date
    05 Jun 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Jun 2019
    First version publication date
    21 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR100916
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01867710
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.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
    05 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the safety of abiraterone acetate with 4 alternative steroid treatment strategies related to symptoms associated with mineralocorticoid excess toxicities (i.e, hypokalemia and/or hypertension) during the first 24 weeks of treatment in asymptomatic, chemotherapy-naive, mCRPC (metastatic castration-resistant prostate cancer) subjects.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations included adverse events (AEs), clinical laboratory tests (insulin resistance, lipids, ACTH [adrenocorticotrophic hormone], serum androgens, urinary steroid excretion, hematology, and serum chemistry, urinalysis), vital sign measurements, dual-energy x-ray absorptiometry (DXA) scans, physical examinations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 41
    Country: Number of subjects enrolled
    Germany: 28
    Country: Number of subjects enrolled
    United Kingdom: 35
    Country: Number of subjects enrolled
    Hungary: 20
    Country: Number of subjects enrolled
    Italy: 40
    Worldwide total number of subjects
    164
    EEA total number of subjects
    164
    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)
    40
    From 65 to 84 years
    118
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Of the 204 subjects who were enrolled, 39 were screen failures and 1 subject withdrew consent before randomization. A total of 164 subjects were randomized to prednisone 5 milligram (mg) BID (41 subjects), prednisone 5 mg QD (41 subjects), prednisone 2.5 mg BID (40 subjects), and dexamethasone 0.5 mg (42 subjects) QD groups.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID
    Arm description
    Subjects received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.
    Arm type
    Experimental

    Investigational medicinal product name
    Abiraterone Acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received abiraterone acetate 1000 mg QD up to 156 weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation.

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received prednisone 5 mg BID up to 156 weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation.

    Arm title
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD
    Arm description
    Subjects received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.
    Arm type
    Experimental

    Investigational medicinal product name
    Abiraterone Acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received abiraterone acetate 1000 mg QD up to 156 weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation.

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received prednisone 5 mg QD up to 156 weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation.

    Arm title
    Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID
    Arm description
    Subjects received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.
    Arm type
    Experimental

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received prednisone 2.5 mg BID up to 156 weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation.

    Investigational medicinal product name
    Abiraterone Acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received abiraterone acetate 1000 mg QD up to 156 weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation.

    Arm title
    Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Arm description
    Subjects received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.
    Arm type
    Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received dexamethasone 0.5 mg QD up to 156 weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation.

    Investigational medicinal product name
    Abiraterone Acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received abiraterone acetate 1000 mg QD up to 156 weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation.

    Number of subjects in period 1
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Started
    41
    41
    40
    42
    Treated
    41
    41
    39
    42
    Completed
    0
    0
    0
    0
    Not completed
    41
    41
    40
    42
         Progressive disease
    1
    -
    -
    -
         Death
    25
    15
    27
    20
         Protocol deviation
    -
    -
    -
    1
         Biochemical progression
    -
    1
    -
    -
         Study terminated by sponsor
    9
    13
    8
    16
         Consent withdrawn by subject
    2
    5
    1
    2
         Study medication no longer effective
    -
    1
    -
    -
         PSA-progression
    -
    1
    -
    -
         Clinical progression
    -
    -
    1
    -
         Disease progression
    1
    -
    -
    -
         Patient to follow subsequent treatment
    -
    1
    -
    -
         Patient decision
    -
    -
    -
    1
         Lost to follow-up
    3
    4
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID
    Reporting group description
    Subjects received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group title
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD
    Reporting group description
    Subjects received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group title
    Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID
    Reporting group description
    Subjects received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group title
    Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Reporting group description
    Subjects received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD Total
    Number of subjects
    41 41 40 42 164
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    12 12 8 8 40
        From 65 to 84 years
    26 28 32 32 118
        85 years and over
    3 1 0 2 6
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    68.9 ± 9.28 69 ± 8.44 69.3 ± 7.51 71.3 ± 8.12 -
    Title for Gender
    Units: subjects
        Male
    41 41 40 42 164

    End points

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    End points reporting groups
    Reporting group title
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID
    Reporting group description
    Subjects received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group title
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD
    Reporting group description
    Subjects received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group title
    Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID
    Reporting group description
    Subjects received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group title
    Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Reporting group description
    Subjects received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Primary: Percentage of Subjects Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment

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    End point title
    Percentage of Subjects Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment [1]
    End point description
    No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension. Safety population included all randomized and treated subjects. Here “N” (Number of subjects analyzed) signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 24
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    34
    38
    35
    37
    Units: Percentage of subjects
    number (confidence interval 95%)
        Percentage of subjects
    70.6 (53.8 to 83.2)
    36.8 (23.4 to 52.7)
    60.0 (43.6 to 74.4)
    70.3 (54.2 to 82.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12

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    End point title
    Percentage of Subjects With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12
    End point description
    The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show >=50% decline from baseline. Intent-to-treat (ITT) population included all randomized subjects regardless of whether they received any study treatment. Here “N” (Number of subjects analyzed) signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    35
    34
    36
    39
    Units: Percentage of subjects
        number (confidence interval 95%)
    57.1 (39.4 to 73.7)
    70.6 (52.5 to 84.9)
    47.2 (30.4 to 64.5)
    79.5 (63.5 to 90.7)
    No statistical analyses for this end point

    Secondary: Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain

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    End point title
    Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain
    End point description
    BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Worst pain item has scale of 0 to 10 with 0 indicating “No pain” and 10 indicating “Pain as bad as you can imagine”. Last observation carried forward (LOCF) approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed. ITT population included all randomized subjects regardless of whether they received any study treatment. Here “N” (Number of Subjects Analyzed) signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of main study treatment period [MSTP])
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    36
    33
    37
    38
    Units: Units on a scale
        arithmetic mean (standard deviation)
    1.6 ± 2.43
    2.2 ± 2.86
    2.5 ± 2.39
    1.3 ± 2.28
    No statistical analyses for this end point

    Secondary: Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale

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    End point title
    Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale
    End point description
    BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of 4 pain scores on BPI-SF; range is 0=No pain to 10=Pain as bad as you can imagine; Higher score indicates greater pain severity. LOCF approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed. ITT population: all randomized subjects regardless of whether they received any study treatment. 'N' (number of subjects analyzed)- number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    37
    35
    37
    38
    Units: Units on a scale
        arithmetic mean (standard deviation)
    1.31 ± 1.788
    1.37 ± 1.952
    1.80 ± 2.014
    0.97 ± 1.610
    No statistical analyses for this end point

    Secondary: Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale

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    End point title
    Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale
    End point description
    BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Interference Index is the mean of the scores for the 7 items of the BPI-SF; range is 0=Does not interfere to 10=Completely interferes. LOCF approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed. ITT population: all randomized subjects regardless of whether they received any study treatment. 'N' (number of subjects analyzed)- number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    32
    30
    35
    37
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.89 ± 1.794
    1.76 ± 2.100
    1.52 ± 2.180
    1.12 ± 1.687
    No statistical analyses for this end point

    Secondary: Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score

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    End point title
    Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score
    End point description
    EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Subject selects answer for each of 5 dimensions considering response that best matches his/her health “today”. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). LOCF approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed. ITT population: all randomized subjects regardless of whether they received any study treatment. 'N' (number of subjects analyzed)- number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    37
    38
    36
    38
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -0.0694 ± 0.18402
    -0.0638 ± 0.17772
    -0.0728 ± 0.18113
    -0.0359 ± 0.13515
    No statistical analyses for this end point

    Secondary: Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS

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    End point title
    Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS
    End point description
    EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent’s own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). LOCF approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed. ITT population: all randomized subjects regardless of whether they received any study treatment. 'N' (number of subjects analyzed)- number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    38
    37
    37
    37
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -4.5 ± 18.11
    -5.0 ± 16.82
    -6.6 ± 15.09
    -3.1 ± 13.00
    No statistical analyses for this end point

    Secondary: Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score

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    End point title
    Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score
    End point description
    FACT-P is 39-item subject rated questionnaire consists of 5 subscales assessing physical well-being (7 items; score range 0-28), social/family well-being (7 items; score range 0-28), emotional well-being (6 items; score range 0-24), functional well-being (7 items; score range 0-28), prostate-specific concerns (12 items; score range 0-48). Each item rated on 0-4 Likert type scale and combined to produce subscale scores for each domain, as well as global QoL score that ranges from 0-156. Higher scores=better QoL. Additional Concerns subscale has 12 items, each with score 0-6 making total subscale range 0-72 (higher scores are better). Missing data imputed per FACT-P Ver4 scoring system (sum of item scores*number of items in subscale/number of items answered). Last observation defined as last visit with non-missing data for parameter. ITT population analyzed. Here 'n'(number of subjects analyzed) signifies number of subjects analyzed in specific category.
    End point type
    Secondary
    End point timeframe
    Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    41
    41
    40
    42
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Physical Well-Being(n=37,38,37,38)
    -0.98 ± 3.930
    -2.20 ± 4.449
    -2.46 ± 4.124
    -1.04 ± 3.268
        Social/Family Well-Being (n=37,37,36,38)
    -0.01 ± 3.679
    0.61 ± 3.794
    -0.78 ± 5.177
    -1.97 ± 5.749
        Emotional Well-Being (n=37,38,35,36)
    -1.46 ± 4.785
    -0.89 ± 3.289
    -1.66 ± 3.915
    -0.02 ± 3.542
        Functional Well-Being (n=36,38,36,36)
    -1.13 ± 4.575
    -2.19 ± 5.767
    -2.67 ± 5.957
    -2.95 ± 6.698
        Global Score (n=35,38,36,34)
    -4.73 ± 18.248
    -6.62 ± 17.118
    -10.39 ± 20.798
    -5.77 ± 18.322
        Additional Concerns (n=37,38,37,38)
    -1.29 ± 7.694
    -2.35 ± 6.342
    -3.96 ± 6.492
    -0.72 ± 6.080
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

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    End point title
    Progression-Free Survival (PFS)
    End point description
    PFS: Time from randomization to one of following: radiographic progression (RP), clinical progression (CP) or death. RP- per PCWG2 criteria and modified RECIST as time from randomization to one of following: 1) considered to have progressed by bone scan if: a) first scan with >=2 new lesions compared to baseline at <12 weeks from randomization and confirmed by second scan >=6 weeks later with >=2 additional new lesions, b) first scan with >=2 new lesions compared to baseline at >=12 weeks from randomization and new lesions on next bone scan >=6 weeks later; 2) Progression of soft tissue lesions per modified RECIST; CP: cancer pain requiring initiation of chronic use of opiate or immediate need to initiate cytotoxic chemotherapy or either radiation therapy or surgical intervention for complications due to tumor progression, even in absence of RP, Or deterioration in ECOG performance status to grade 3 or above. Efficacy analysis set included ITT population.
    End point type
    Secondary
    End point timeframe
    Up to 4.9 years
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    41
    41
    40
    42
    Units: Months
        median (confidence interval 95%)
    16.16 (9.95 to 23.75)
    12.68 (7.66 to 29.47)
    8.51 (5.62 to 15.44)
    21.22 (15.08 to 38.44)
    No statistical analyses for this end point

    Secondary: Time to Prostate-Specific Antigen (PSA) Progression

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    End point title
    Time to Prostate-Specific Antigen (PSA) Progression
    End point description
    Time to PSA progression was defined as time interval from the date of randomization to the date of the first prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group 2 (PSAWG2) criteria during the main study treatment period. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. Efficacy analysis set included ITT population- all randomized subjects regardless of whether they received any study treatment. '99999' indicates that upper limit of 95% Confidence Interval (CI) was not estimable due to a limited number of events and the small sample size.
    End point type
    Secondary
    End point timeframe
    Up to 156 weeks
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    41
    41
    40
    42
    Units: Months
        median (confidence interval 95%)
    10.38 (10.05 to 20.99)
    10.22 (7.39 to 26.84)
    4.83 (2.79 to 10.15)
    18.56 (10.15 to 99999)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    Objective Response Rate (ORR)
    End point description
    ORR was defined as the percentage of subjects with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions , any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 millimetre [mm] short axis). PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Efficacy analysis set included ITT population- all randomized subjects regardless of whether they received any study treatment. Population included subjects with measurable disease at baseline.
    End point type
    Secondary
    End point timeframe
    Up to 4.9 years
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    19
    18
    10
    16
    Units: Percentage of subjects
        number (not applicable)
    42.1
    38.9
    60.0
    56.3
    No statistical analyses for this end point

    Secondary: Time to Opiate Use for Cancer-related Pain

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    End point title
    Time to Opiate Use for Cancer-related Pain
    End point description
    Time to opiate use for cancer-related pain is defined the time interval from the date of randomization to the first date of opiate use for cancer pain. Efficacy analysis set included ITT population- all randomized subjects regardless of whether they received any study treatment. '99999' indicates that median and 95% Confidence Interval (CI) were not estimable due to a limited number of events and the small sample size.
    End point type
    Secondary
    End point timeframe
    Up to 156 weeks
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    41
    41
    40
    42
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point

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    End point title
    Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point
    End point description
    Time to deterioration in ECOG Performance Status, the time interval from the date of randomization to the first date in which at least one point change (worsening) in the ECOG is observed during the main study treatment period. The ECOG performance status is a grade scale to measure quality of life (QoL). Scores run from 0 to 5, with 0 denoting perfect health and 5 denoting death. Efficacy analysis set included ITT population- all randomized subjects regardless of whether they received any study treatment. '99999' indicates that median and 95% Confidence Interval (CI) was not estimable due to a limited number of events and the small sample size.
    End point type
    Secondary
    End point timeframe
    Up to 156 weeks
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    41
    41
    40
    42
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (23.95 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    Overall Survival
    End point description
    Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. Efficacy analysis set included ITT population- all randomized subjects regardless of whether they received any study treatment. Here '99999' indicates that median and upper limit of 95% Confidence Interval (CI) was not estimable due to a limited number of events and the small sample size.
    End point type
    Secondary
    End point timeframe
    Up to 4.9 years
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    41
    41
    40
    42
    Units: Months
        median (confidence interval 95%)
    34.07 (26.38 to 48.49)
    48.43 (39.95 to 99999)
    27.96 (23.66 to 40.51)
    42.81 (30.23 to 99999)
    No statistical analyses for this end point

    Secondary: Time to Next Prostate Cancer Therapy

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    End point title
    Time to Next Prostate Cancer Therapy
    End point description
    Time to next prostate cancer therapy is defined as the time interval from the date of randomization to the date of initiation of first next therapy for prostate cancer. Efficacy analysis set included ITT population- all randomized subjects regardless of whether they received any study treatment.
    End point type
    Secondary
    End point timeframe
    Up to 4.9 years
    End point values
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Number of subjects analysed
    41
    41
    40
    42
    Units: Months
        median (confidence interval 95%)
    20.14 (13.27 to 26.91)
    19.48 (12.09 to 33.08)
    16.66 (9.26 to 22.47)
    28.29 (20.83 to 38.90)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 4.9 years
    Adverse event reporting additional description
    Safety population included all randomized and treated subjects.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID
    Reporting group description
    Subjects received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group title
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD
    Reporting group description
    Subjects received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Subjects who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group title
    Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID
    Reporting group description
    Subjects received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Subjects who were progression free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Reporting group title
    Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Reporting group description
    Subjects received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Subjects who were progression free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Subjects who ended the extension phase prematurely and subjects who did not enter the extension phase entered a follow-up phase until end of study.

    Serious adverse events
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 41 (29.27%)
    10 / 41 (24.39%)
    11 / 39 (28.21%)
    18 / 42 (42.86%)
         number of deaths (all causes)
    25
    15
    26
    20
         number of deaths resulting from adverse events
    Vascular disorders
    Circulatory Collapse
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Myelodysplastic Syndrome
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine Carcinoma of the Skin
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Performance Status Decreased
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychotic Disorder
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic Pain
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint Injury
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Flutter
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular Arrhythmia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural Effusion
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Blood and lymphatic system disorders
    Anaemia of Malignant Disease
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral Infarction
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's Type
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness Postural
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frontotemporal Dementia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage Intracranial
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokinesia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve Root Compression
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    3 / 42 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vision Blurred
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated Inguinal Hernia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive Pancreatitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic Cyst
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder Tamponade
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device Occlusion
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthropathy
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flank Pain
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mobility Decreased
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ketosis
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 41 (95.12%)
    36 / 41 (87.80%)
    37 / 39 (94.87%)
    39 / 42 (92.86%)
    Vascular disorders
    Hot Flush
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    3 / 39 (7.69%)
    5 / 42 (11.90%)
         occurrences all number
    3
    1
    3
    6
    Hypertension
         subjects affected / exposed
    14 / 41 (34.15%)
    22 / 41 (53.66%)
    13 / 39 (33.33%)
    10 / 42 (23.81%)
         occurrences all number
    30
    47
    21
    16
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    3
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 41 (7.32%)
    4 / 41 (9.76%)
    1 / 39 (2.56%)
    1 / 42 (2.38%)
         occurrences all number
    6
    8
    1
    1
    Chest Pain
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 41 (7.32%)
    1 / 39 (2.56%)
    1 / 42 (2.38%)
         occurrences all number
    0
    3
    2
    1
    Fatigue
         subjects affected / exposed
    2 / 41 (4.88%)
    6 / 41 (14.63%)
    5 / 39 (12.82%)
    7 / 42 (16.67%)
         occurrences all number
    2
    11
    5
    7
    Influenza Like Illness
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    5
    0
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    8 / 41 (19.51%)
    4 / 41 (9.76%)
    4 / 39 (10.26%)
    8 / 42 (19.05%)
         occurrences all number
    10
    5
    5
    12
    Pyrexia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    2 / 39 (5.13%)
    1 / 42 (2.38%)
         occurrences all number
    1
    1
    3
    1
    Reproductive system and breast disorders
    Pelvic Pain
         subjects affected / exposed
    3 / 41 (7.32%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    7
    2
    0
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    3
    0
    0
    4
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    3 / 41 (7.32%)
    2 / 41 (4.88%)
    3 / 39 (7.69%)
    5 / 42 (11.90%)
         occurrences all number
    12
    2
    3
    10
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 41 (4.88%)
    3 / 39 (7.69%)
    4 / 42 (9.52%)
         occurrences all number
    6
    2
    4
    7
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    3 / 42 (7.14%)
         occurrences all number
    1
    1
    1
    4
    Blood Bilirubin Increased
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Blood Lactate Dehydrogenase Increased
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 42 (0.00%)
         occurrences all number
    0
    0
    2
    0
    C-Reactive Protein Increased
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 42 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hepatic Enzyme Increased
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    0
    0
    13
    Weight Decreased
         subjects affected / exposed
    7 / 41 (17.07%)
    7 / 41 (17.07%)
    10 / 39 (25.64%)
    3 / 42 (7.14%)
         occurrences all number
    11
    9
    12
    3
    Weight Increased
         subjects affected / exposed
    4 / 41 (9.76%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    6 / 42 (14.29%)
         occurrences all number
    6
    4
    1
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    4 / 42 (9.52%)
         occurrences all number
    1
    1
    1
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    3 / 39 (7.69%)
    0 / 42 (0.00%)
         occurrences all number
    2
    1
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 41 (4.88%)
    2 / 39 (5.13%)
    3 / 42 (7.14%)
         occurrences all number
    2
    2
    3
    3
    Paraesthesia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    2 / 42 (4.76%)
         occurrences all number
    0
    0
    2
    2
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    4 / 41 (9.76%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    0 / 42 (0.00%)
         occurrences all number
    5
    3
    1
    0
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    3 / 39 (7.69%)
    2 / 42 (4.76%)
         occurrences all number
    2
    1
    3
    2
    Constipation
         subjects affected / exposed
    9 / 41 (21.95%)
    4 / 41 (9.76%)
    3 / 39 (7.69%)
    2 / 42 (4.76%)
         occurrences all number
    9
    5
    4
    2
    Diarrhoea
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 41 (7.32%)
    2 / 39 (5.13%)
    1 / 42 (2.38%)
         occurrences all number
    3
    8
    2
    2
    Dry Mouth
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Nausea
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 41 (4.88%)
    2 / 39 (5.13%)
    3 / 42 (7.14%)
         occurrences all number
    1
    3
    2
    3
    Vomiting
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 41 (4.88%)
    2 / 39 (5.13%)
    2 / 42 (4.76%)
         occurrences all number
    2
    2
    2
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    2 / 39 (5.13%)
    3 / 42 (7.14%)
         occurrences all number
    3
    1
    3
    3
    Urinary Retention
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 41 (7.32%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    2
    3
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    3 / 39 (7.69%)
    1 / 42 (2.38%)
         occurrences all number
    2
    0
    3
    2
    Skin Atrophy
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    0
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 41 (21.95%)
    9 / 41 (21.95%)
    2 / 39 (5.13%)
    2 / 42 (4.76%)
         occurrences all number
    14
    12
    2
    2
    Back Pain
         subjects affected / exposed
    13 / 41 (31.71%)
    5 / 41 (12.20%)
    10 / 39 (25.64%)
    9 / 42 (21.43%)
         occurrences all number
    16
    8
    13
    13
    Bone Pain
         subjects affected / exposed
    11 / 41 (26.83%)
    3 / 41 (7.32%)
    5 / 39 (12.82%)
    2 / 42 (4.76%)
         occurrences all number
    14
    4
    7
    2
    Groin Pain
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Muscle Spasms
         subjects affected / exposed
    4 / 41 (9.76%)
    1 / 41 (2.44%)
    4 / 39 (10.26%)
    2 / 42 (4.76%)
         occurrences all number
    7
    1
    4
    3
    Musculoskeletal Pain
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    2 / 39 (5.13%)
    2 / 42 (4.76%)
         occurrences all number
    3
    1
    3
    3
    Myalgia
         subjects affected / exposed
    2 / 41 (4.88%)
    5 / 41 (12.20%)
    0 / 39 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Osteopenia
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 41 (7.32%)
    0 / 39 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    3
    3
    0
    1
    Osteoporosis
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    3 / 42 (7.14%)
         occurrences all number
    1
    1
    1
    3
    Pain in Extremity
         subjects affected / exposed
    5 / 41 (12.20%)
    2 / 41 (4.88%)
    4 / 39 (10.26%)
    3 / 42 (7.14%)
         occurrences all number
    6
    2
    7
    4
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    2 / 39 (5.13%)
    1 / 42 (2.38%)
         occurrences all number
    2
    1
    2
    1
    Hypokalaemia
         subjects affected / exposed
    5 / 41 (12.20%)
    7 / 41 (17.07%)
    7 / 39 (17.95%)
    7 / 42 (16.67%)
         occurrences all number
    6
    13
    9
    11
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    2
    0
    4
    Nasopharyngitis
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    3 / 39 (7.69%)
    2 / 42 (4.76%)
         occurrences all number
    3
    1
    5
    2
    Urinary Tract Infection
         subjects affected / exposed
    1 / 41 (2.44%)
    4 / 41 (9.76%)
    0 / 39 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    1
    5
    0
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Nov 2013
    Amendment INT-2 included following changes: Adjusted inclusion/exclusion criteria to include subjects with liver or lung visceral metastases, subjects treated with a maximum of 2 anti-hypertensives, and subjects who previously received palliative radiotherapy for prostate cancer; adjusted exclusion criteria to exclude subjects who received prior corticosteroid treatment for prostate cancer; modified birth control requirements during the study; clarified procedural aspects of the study, including definitions of study completion and procedures associated with discontinuation; clarified concomitant therapy during the main study treatment period and extension phase.
    27 Nov 2014
    Amendment INT-4 included following changes: Referenced additional information on potential drug-drug interactions, including those related to CYP1A2, CYP2D6, and CYP2C8; clarified the scope and timing of data analyses; described dosing compliance procedures.

    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.
    Study not designed/powered to allow comparisons in study groups. Per protocol amendment 6, the study was ended earlier since sufficient extension and follow-up data have been collected to allow statistical analysis of secondary objectives.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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