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    Clinical Trial Results:
    Abiraterona acetate maintenance in combination with docetaxel after disease progression to abiraterona acetate in metastatic castration resistant prostate cancer. Randomized phase II study.

    Summary
    EudraCT number
    		 2013-003811-23
    Trial protocol
    		 ES  
    Global end of trial date
    08 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2021
    First version publication date
    16 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABIDO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02036060
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SOGUG - Spanish Oncology Genitourinary Group
    Sponsor organisation address
    Calle Velázquez, 7, planta 3, Madrid , Spain, 28001
    Public contact
    Clinical Operations Department, APICES SOLUCIONES, S.L., +34 91 816 68 04 Ext 103, ana.moreno@apices.es
    Scientific contact
    Clinical Operations Department, APICES SOLUCIONES, S.L., +34 91 816 68 04 Ext103, ana.moreno@apices.es
    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
    17 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    12 months radiologic progression free survival of two arms of treatment (docetaxel + prednisone + abiraterone or docetaxel + prednisone) in metastatic castration resistant prostate cancer
    Protection of trial subjects
    Randomization
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2014
    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
    Spain: 148
    Worldwide total number of subjects
    148
    EEA total number of subjects
    148
    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)
    39
    From 65 to 84 years
    101
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in the study from 07th February 2014 until 27th July 2016. Patients were randomised in the study from 30th July 2014 until 26th February 2019.

    Pre-assignment
    Screening details
    		 Patients included in the study had had to show histologically or cytologically confirmed adenocarcinoma of the prostate, be asymptomatic or mildly symptomatic from prostate cancer, received previous anti-androgen therapy and progression after withdrawal, have a Life expectancy of at least 6 months, ECOG PS of 0-1 and adequate organ function.

    Pre-assignment period milestones
    Number of subjects started
    		 148
    Number of subjects completed
    		 94

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Pre-randomisation loss (94 randomized): 54
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Docetaxel + Prednisone + abiraterone
    Arm description
    		 Docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d in 21 day cycles.
    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
    4 tables of 250 mg/day (1000 mg)

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75 mg/m2 every 21 days

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg daily

    Arm title
    		 Arm B: Docetaxel + Prednisone
    Arm description
    		 Docetaxel 75 mg/m2 plus prednisone 10 mg/d in 21 day cycles.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75 mg/m2 every 21 days

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg daily

    Number of subjects in period 1 [1]
    		Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Started
    47
    47
    Completed
    22
    20
    Not completed
    25
    27
         Physician decision
    1
    -
         Disease progression
    14
    14
         Development of other intercurrent diseases
    1
    4
         Unacceptable toxicity
    5
    7
         Exitus
    4
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: During stage I of study, 148 patients were included. Prior to the start of Phase II, 54 patients were pre-randomisation failures, resulting in a total of 94 patients participating in stage II of the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Docetaxel + Prednisone + abiraterone
    Reporting group description
    		 Docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d in 21 day cycles.

    Reporting group title
    Arm B: Docetaxel + Prednisone
    Reporting group description
    		 Docetaxel 75 mg/m2 plus prednisone 10 mg/d in 21 day cycles.

    Reporting group values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone Total
    Number of subjects
    		 47 47 94
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 13 19 32
        From 65-84 years
    		 31 28 59
        85 years and over
    		 3 0 3
    Age continuous
    Units: years
        median (full range (min-max))
    		 70.0 (51.0 to 85.0) 68.0 (45.0 to 84.0) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 47 47 94
    Ethnics
    Units: Subjects
        Caucasian
    		 46 46 92
        African
    		 0 1 1
        Arab
    		 1 0 1
    Risk behaviours: Tobacco
    Units: Subjects
        Yes
    		 9 11 20
        No
    		 36 36 72
        Not available
    		 2 0 2
    Risk behaviours: Alcohol
    Units: Subjects
        Yes
    		 3 9 12
        No
    		 42 38 80
        Not available
    		 2 0 2
    Intercurrent disease
    Units: Subjects
        Yes
    		 41 40 81
        No
    		 6 7 13
    ECOG-PS
    Units: Subjects
        0)
    		 23 16 39
        1)
    		 21 26 47
        2)
    		 3 5 8
    TNM: Stage at initial diagnosis
    Units: Subjects
        I)
    		 2 0 2
        II)
    		 7 4 11
        IIA)
    		 1 0 1
        III)
    		 11 7 18
        IV)
    		 22 26 48
        Not available
    		 4 10 14
    Gleason score at initial diagnosis
    Units: Subjects
        <8
    		 19 19 38
        ≥8
    		 26 20 46
        Not available
    		 2 8 10
    Previous therapy: Radical prostatectomy
    Units: Subjects
        Yes
    		 14 10 24
        No
    		 33 37 70
    Previous therapy: Radical radiotherapy
    Units: Subjects
        Yes
    		 11 14 25
        No
    		 36 33 69
    Tumor location: Bone
    Units: Subjects
        Yes
    		 40 40 80
        No
    		 7 7 14
    Tumor location: Lymph nodes
    Units: Subjects
        Yes
    		 27 30 57
        No
    		 20 17 37
    Tumor location: Liver
    Units: Subjects
        Yes
    		 4 4 8
        No
    		 43 43 86
    Number of locations per patient
    Units: Subjects
        1)
    		 22 17 39
        2)
    		 18 19 37
        3)
    		 5 6 11
        4)
    		 1 3 4
        Non Evaluable
    		 1 2 3
    Height
    Units: Cm
        median (full range (min-max))
    		 168.3 (154.0 to 196.0) 169.0 (153.0 to 182.0) -
    Weight
    Units: Kg
        median (full range (min-max))
    		 79.3 (63.0 to 116.6) 82.0 (53.5 to 117.0) -
    Time since initial diagnosis
    Units: Months
        median (full range (min-max))
    		 48.8 (7.8 to 207.3) 39.6 (6.8 to 188.6) -
    Time since metastasic diagnosis
    Units: Months
        median (full range (min-max))
    		 11.7 (0.2 to 137.3) 14.9 (0.5 to 113.8) -
    Treatment duration of abiraterone phase I
    Units: Months
        median (full range (min-max))
    		 12.1 (2.6 to 60.0) 13.6 (2.8 to 39.9) -
    Number of cycles phase II
    Units: Cycles
        median (full range (min-max))
    		 8.0 (1.0 to 10.0) 8.0 (1.0 to 10.0) -
    Relative dose intensity of docetaxel
    Units: Percentage
        median (full range (min-max))
    		 87 (50 to 96) 87 (63 to 100) -
    Relative dose intensity of abiraterone phase II (only Arm A)
    Units: Percentage
        median (full range (min-max))
    		 94 (50 to 101) 0 (0 to 0) -
    PSA at baseline
    Units: ng/ml
        median (full range (min-max))
    		 73 (1 to 1401) 34 (0 to 4256) -

    End points

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    End points reporting groups
    Reporting group title
    Arm A: Docetaxel + Prednisone + abiraterone
    Reporting group description
    		 Docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d in 21 day cycles.

    Reporting group title
    Arm B: Docetaxel + Prednisone
    Reporting group description
    		 Docetaxel 75 mg/m2 plus prednisone 10 mg/d in 21 day cycles.

    Primary: Radiological progression-free survival at 12 Months

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    End point title
    		 Radiological progression-free survival at 12 Months [1]
    End point description
    Radiological progression-free survival was defined as the time elapsed, in months, from the time the patient is randomised into the study until the patient progresses according to RECIST criteria and PCWG2 criteria or dies for any cause.
    End point type
    Primary
    End point timeframe
    Every 12 weeks
    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 analyses have been performed. Phase II non-comparative study.
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    47
    47
    Units: Percentage
        number (confidence interval 95%)
    34.9 (20.7 to 49.2)
    33.9 (19.5 to 48.3)
    Attachments
    		 Untitled (Filename: rSLP.png)
    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 elapsed, in months, from the time the patient was randomised into the study until death for any cause.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    47
    47
    Units: Months
        median (confidence interval 95%)
    17.368 (14.058 to 20.679)
    16.908 (9.792 to 24.023)
    No statistical analyses for this end point

    Secondary: Radiological progression-free survival of study arms

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    End point title
    		 Radiological progression-free survival of study arms
    End point description
    Radiological progression-free survival was defined as the time elapsed, in months, from the time the patient is randomised into the study until the patient progresses according to RECIST criteria and PCWG2 criteria or dies for any cause.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    47
    47
    Units: Months
        median (confidence interval 95%)
    8.816 (5.948 to 11.684)
    9.770 (7.234 to 12.305)
    No statistical analyses for this end point

    Secondary: PSA progression free survival

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    End point title
    		 PSA progression free survival
    End point description
    PSA progression-free survival was defined as the time elapsed, in months, from the time the patient was randomised in the study until PSA progression, radiological progression or death for any cause.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    47
    47
    Units: Months
        median (confidence interval 95%)
    5.428 (3.614 to 7.241)
    5.39 (4.003 to 5.928)
    No statistical analyses for this end point

    Secondary: Biochemical response rate 50%

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    End point title
    		 Biochemical response rate 50%
    End point description
    Biochemical response has been defined as a reduction in PSA concentration of greater than 50% from the baseline stage II visit (first available determination prior to initiation of docetaxel treatment)
    End point type
    Secondary
    End point timeframe
    Everyb 4 weeks
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    47
    47
    Units: % of Subjects
        Response
    64
    47
        No response
    36
    53
    No statistical analyses for this end point

    Secondary: Biochemical response rate 90%

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    End point title
    		 Biochemical response rate 90%
    End point description
    Biochemical response has been defined as a reduction in PSA concentration of greater than 50% from the baseline stage II visit (first available determination prior to initiation of docetaxel treatment).
    End point type
    Secondary
    End point timeframe
    Every 4 weeks
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    47
    47
    Units: % of subjects
        Response
    21
    11
        No response
    79
    89
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Objective response has been calculated taking into account patients which has been response to treatment. In this case, 7 patients of Arm A and 3 patients of Arm B had a partial response to treatment.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    47
    47
    Units: % of subjects
        number (confidence interval 95%)
    14.9 (4.7 to 25.1)
    6.4 (0 to 13.4)
    No statistical analyses for this end point

    Secondary: Mean change from baseline in the FACT-P total score (SD)b

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    End point title
    		 Mean change from baseline in the FACT-P total score (SD)b
    End point description
    The FACT-P scale includes 5 fields corresponding the following ranges: general physical status (range 0-28), family and social environment (range 0-28), emotional status (range 0-24), functioning ability (range 0-28) and prostate cancer specific symptoms (range 0-48); plus a total score (range 0-156). The higher the score, the better the quality of life.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    26
    31
    Units: Score
        median (full range (min-max))
    -0.5 (-69.3 to 41.3)
    -1.3 (-38.6 to 42.5)
    No statistical analyses for this end point

    Secondary: Time to skeletal event

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    End point title
    		 Time to skeletal event
    End point description
    Time to skeletal event is defined has been defined as the time elapsed from randomization until the onset of skeletal event. The following were considered skeletal events: pathological fracture, spinal cord compression, radiotherapy or bone surgery, and hypercalcaemia of bone metastasis, occurring after randomisation in phase II. 9 patients (4 of Arm A and 5 of Arm B)shown skeletal events during stage II of the study.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks.
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    4
    5
    Units: Months
        median (full range (min-max))
    1.2 (0.7 to 6.1)
    7.8 (4.0 to 8.9)
    No statistical analyses for this end point

    Secondary: Time to opiate initiation

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    End point title
    		 Time to opiate initiation
    End point description
    Time to opiate initiation was defined as the time elapsed, in months, from the patient was randomised in the study until opioide treatment initiation for oncologic pain. 35 patients (18 in arm A and 17 in arm B) started treatment with newly prescribed opioids. Four patients in both arms started opioid treatment on the same day they were randomised in stage II of the study.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    18
    17
    Units: Months
        median (full range (min-max))
    3.2 (0.0 to 14.7)
    1.4 (0.0 to 5.5)
    No statistical analyses for this end point

    Secondary: Worsening of pain according to BPI-SF

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    End point title
    		 Worsening of pain according to BPI-SF
    End point description
    Worsening of pain has been defined as an increase of at least 2 points, with respect to the lowest value measured during stage II, in item 3 of the BPI scale.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks
    End point values
    		 Arm A: Docetaxel + Prednisone + abiraterone Arm B: Docetaxel + Prednisone
    Number of subjects analysed
    47
    47
    Units: Patients
        Yes
    25
    26
        No
    22
    21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During phase II of study treatment (After randomization)
    Adverse event reporting additional description
    Adverse events are shown in two groups depending on the treatment arm in which they occurred, differentiated as follows: Arm A: Docetaxel + prednisone + Abiraterone. Arm B: Docetaxel + prednisone
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Arm A: Docetaxel + Prednisone + Abiraterone
    Reporting group description
    		 -

    Reporting group title
    Arm B: Docetaxel + Prednisone
    Reporting group description
    		 -

    Reporting group title
    Total
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A: Docetaxel + Prednisone + Abiraterone Arm B: Docetaxel + Prednisone Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 47 (65.96%)
    20 / 47 (42.55%)
    51 / 94 (54.26%)
         number of deaths (all causes)
    37
    29
    66
         number of deaths resulting from adverse events
    6
    1
    7
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastrointestinal stromal tumour
    Additional description: Gastrointestinal stromal tumour grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Phlebitis
    Additional description: Phlebitis grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Nephrostomy
    Additional description: Nephrostomy grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transurethral resection of bladder tumor
    Additional description: Transurethral resection of bladder tumor grade 2
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
    Additional description: 1 General physical health deterioration grade 4, 1 grade 3 and 1 grade 2. General physical health deterioration grade 4 related with docetaxel. General physical health deterioration grade 3 related with abidaterone.
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 47 (0.00%)
    3 / 94 (3.19%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General body pain
    Additional description: General body pain grade 3
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fever
    Additional description: Fever grade 1 related with abiraterone
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucositis
    Additional description: Mucositis grade 3 related with docetaxel
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory insufficiency
    Additional description: Acute respiratory insufficiency grade 5
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Chronic obstructive pulmonary disease exacerbation
    Additional description: 2 Chronic obstructive pulmonary disease exacerbation grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 47 (4.26%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
    Additional description: Neutrophil count decreased grade 4 related with docetaxel
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GGT increased
    Additional description: GGT increased grade 4
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
    Additional description: 2 Hip fracture grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 47 (4.26%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
    Additional description: Rib fracture grade 2
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung injury
    Additional description: Lung injury grade 3
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute cardiac event
    Additional description: Acute cardiac event grade 5 related with abidaterone and docetaxel
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    Cardiac failure congestive
    Additional description: Cardiac failure congestive grade 3 related with abiraterone and docetaxel
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain stem stroke
    Additional description: Brain stem stroke Grade 5
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Spinal cord compression
    Additional description: 1 Spinal cord compression Grade 3 and 1 Grade 5
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 47 (0.00%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Hepatic encephalopathy
    Additional description: Hepatic encephalopathy grade 4 related with docetaxel
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia Grade 4
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
    Additional description: 2 Leukopenia grade 4 related with docetaxel
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 47 (2.13%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
    Additional description: 2 Neutropenia grade 3 (1 in Arm A and 1 in Arm B) and 20 grade 4 (18 in Arm A and 2 in Arm B). All related with docetaxel and one of them with abiraterone
         subjects affected / exposed
    19 / 47 (40.43%)
    3 / 47 (6.38%)
    22 / 94 (23.40%)
         occurrences causally related to treatment / all
    19 / 19
    3 / 3
    22 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
    Additional description: 8 febrile neutropenia grade 3 (2 in Arm A and 6 in Arm B) and 7 grade 4 (6 in Arm A and 1 in Arm B), all related with docetaxel.
         subjects affected / exposed
    8 / 47 (17.02%)
    7 / 47 (14.89%)
    15 / 94 (15.96%)
         occurrences causally related to treatment / all
    8 / 8
    7 / 7
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
    Additional description: 2 diarrohoea grade 3 related with docetaxel.
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 47 (4.26%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis leukopenic
    Additional description: Enteritis leukopenic grade 4 related with docetaxel
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
    Additional description: Constipation grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mesenteric ischemia
    Additional description: Mesenteric ischemia grade 5 related with docetaxel
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    Renal and urinary disorders
    Hematuria
    Additional description: 5 Hematuria grade 3
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 47 (2.13%)
    5 / 94 (5.32%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Insufficiency renal
    Additional description: Insufficiency renal grade 3
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Knee arthritis
    Additional description: Knee arthritis Grade 3
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar pain
    Additional description: Lumbar pain grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone pain
    Additional description: Bone pain grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic bone pain
    Additional description: Pelvic bone pain grade 3
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Influenza A virus infection
    Additional description: Influenza A virus infection grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 47 (2.13%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory infection
    Additional description: 2 Respiratory infection grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 47 (4.26%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
    Additional description: 2 Lower respiratory tract infection grade 3
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 47 (2.13%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: 1 Urinary tract infection grade 3 and 1 grade 2
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 47 (4.26%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary infection
    Additional description: 2 Urinary infection grade 3
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 47 (4.26%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    Additional description: 3 Pneumonia grade 3, 1 related with docetaxel
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 47 (0.00%)
    3 / 94 (3.19%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
    Additional description: 1 Sepsis grade 3 (Arm A) and 1 grade 4 (Arm B). Sepsis grade 4 related with docetaxel.
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 47 (2.13%)
    2 / 94 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridial sepsis
    Additional description: Clostridial sepsis grade 3 related with docetaxel
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
    Additional description: Urosepsis grade 2
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
    Additional description: 1 Septic shock grade 3 (Arm A) and 2 grade 5 (1 in Arm A and 1 in Arm B). 1 shock septic grade 5 (Arm A) related with docetaxel.
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 47 (2.13%)
    3 / 94 (3.19%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    1 / 2
    Metabolism and nutrition disorders
    Fluid retention
    Additional description: Fluid retention grade 3 related with docetaxel
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 47 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A: Docetaxel + Prednisone + Abiraterone Arm B: Docetaxel + Prednisone Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 47 (100.00%)
    44 / 47 (93.62%)
    91 / 94 (96.81%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 47 (8.51%)
    7 / 94 (7.45%)
         occurrences all number
    6
    5
    11
    Hypotension
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 47 (2.13%)
    5 / 94 (5.32%)
         occurrences all number
    6
    2
    8
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    37 / 47 (78.72%)
    34 / 47 (72.34%)
    71 / 94 (75.53%)
         occurrences all number
    94
    83
    177
    General physical health deterioration
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 47 (0.00%)
    4 / 94 (4.26%)
         occurrences all number
    4
    0
    4
    Pain
         subjects affected / exposed
    5 / 47 (10.64%)
    3 / 47 (6.38%)
    8 / 94 (8.51%)
         occurrences all number
    6
    4
    10
    Thoracic pain
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 47 (0.00%)
    3 / 94 (3.19%)
         occurrences all number
    3
    0
    3
    Oedema
         subjects affected / exposed
    7 / 47 (14.89%)
    0 / 47 (0.00%)
    7 / 94 (7.45%)
         occurrences all number
    8
    0
    8
    Oedema peripheral
         subjects affected / exposed
    11 / 47 (23.40%)
    6 / 47 (12.77%)
    17 / 94 (18.09%)
         occurrences all number
    13
    6
    19
    Fatigue
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 47 (0.00%)
    3 / 94 (3.19%)
         occurrences all number
    6
    0
    6
    Mucosal inflammation
         subjects affected / exposed
    13 / 47 (27.66%)
    11 / 47 (23.40%)
    24 / 94 (25.53%)
         occurrences all number
    17
    16
    33
    Pyrexia
         subjects affected / exposed
    12 / 47 (25.53%)
    9 / 47 (19.15%)
    21 / 94 (22.34%)
         occurrences all number
    13
    11
    24
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 47 (2.13%)
    5 / 94 (5.32%)
         occurrences all number
    4
    2
    6
    Dyspnoea
         subjects affected / exposed
    6 / 47 (12.77%)
    1 / 47 (2.13%)
    7 / 94 (7.45%)
         occurrences all number
    7
    1
    8
    Cough
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 47 (6.38%)
    7 / 94 (7.45%)
         occurrences all number
    5
    5
    10
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 47 (4.26%)
    4 / 47 (8.51%)
    6 / 94 (6.38%)
         occurrences all number
    2
    4
    6
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 47 (6.38%)
    4 / 94 (4.26%)
         occurrences all number
    5
    8
    13
    Blood alkaline phosphatase increased
         subjects affected / exposed
    8 / 47 (17.02%)
    5 / 47 (10.64%)
    13 / 94 (13.83%)
         occurrences all number
    9
    11
    20
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    8 / 47 (17.02%)
    13 / 47 (27.66%)
    21 / 94 (22.34%)
         occurrences all number
    12
    17
    29
    Dizziness
         subjects affected / exposed
    2 / 47 (4.26%)
    4 / 47 (8.51%)
    6 / 94 (6.38%)
         occurrences all number
    2
    4
    6
    Neuropathy peripheral
         subjects affected / exposed
    7 / 47 (14.89%)
    7 / 47 (14.89%)
    14 / 94 (14.89%)
         occurrences all number
    11
    9
    20
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 47 (0.00%)
    4 / 47 (8.51%)
    4 / 94 (4.26%)
         occurrences all number
    0
    6
    6
    Neurotoxicity
         subjects affected / exposed
    4 / 47 (8.51%)
    9 / 47 (19.15%)
    13 / 94 (13.83%)
         occurrences all number
    5
    10
    15
    Paresthesia
         subjects affected / exposed
    6 / 47 (12.77%)
    4 / 47 (8.51%)
    10 / 94 (10.64%)
         occurrences all number
    12
    6
    18
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    13 / 47 (27.66%)
    8 / 47 (17.02%)
    21 / 94 (22.34%)
         occurrences all number
    24
    12
    36
    Leukopenia
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 47 (6.38%)
    3 / 94 (3.19%)
         occurrences all number
    0
    3
    3
    Neutropenia
         subjects affected / exposed
    18 / 47 (38.30%)
    16 / 47 (34.04%)
    34 / 94 (36.17%)
         occurrences all number
    28
    19
    47
    Febrile neutropenia
         subjects affected / exposed
    8 / 47 (17.02%)
    6 / 47 (12.77%)
    14 / 94 (14.89%)
         occurrences all number
    8
    6
    14
    Eye disorders
    Excess tears
         subjects affected / exposed
    9 / 47 (19.15%)
    4 / 47 (8.51%)
    13 / 94 (13.83%)
         occurrences all number
    10
    5
    15
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    26 / 47 (55.32%)
    24 / 47 (51.06%)
    50 / 94 (53.19%)
         occurrences all number
    46
    67
    113
    Abdominal pain
         subjects affected / exposed
    5 / 47 (10.64%)
    2 / 47 (4.26%)
    7 / 94 (7.45%)
         occurrences all number
    8
    4
    12
    Abdominal pain upper
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 47 (4.26%)
    5 / 94 (5.32%)
         occurrences all number
    3
    2
    5
    Constipation
         subjects affected / exposed
    14 / 47 (29.79%)
    12 / 47 (25.53%)
    26 / 94 (27.66%)
         occurrences all number
    25
    15
    40
    Nausea
         subjects affected / exposed
    12 / 47 (25.53%)
    12 / 47 (25.53%)
    24 / 94 (25.53%)
         occurrences all number
    17
    25
    42
    Vomiting
         subjects affected / exposed
    5 / 47 (10.64%)
    8 / 47 (17.02%)
    13 / 94 (13.83%)
         occurrences all number
    7
    13
    20
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    19 / 47 (40.43%)
    19 / 47 (40.43%)
    38 / 94 (40.43%)
         occurrences all number
    32
    22
    54
    Nail dystrophy
         subjects affected / exposed
    5 / 47 (10.64%)
    3 / 47 (6.38%)
    8 / 94 (8.51%)
         occurrences all number
    5
    4
    9
    Erythema
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 47 (8.51%)
    7 / 94 (7.45%)
         occurrences all number
    3
    4
    7
    Eruption
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 47 (4.26%)
    5 / 94 (5.32%)
         occurrences all number
    3
    2
    5
    Onycholysis
         subjects affected / exposed
    6 / 47 (12.77%)
    4 / 47 (8.51%)
    10 / 94 (10.64%)
         occurrences all number
    10
    5
    15
    Pruritus
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 47 (6.38%)
    4 / 94 (4.26%)
         occurrences all number
    1
    5
    6
    Skin toxicity
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 47 (6.38%)
    6 / 94 (6.38%)
         occurrences all number
    4
    6
    10
    Nail disorder
         subjects affected / exposed
    8 / 47 (17.02%)
    7 / 47 (14.89%)
    15 / 94 (15.96%)
         occurrences all number
    15
    13
    28
    Renal and urinary disorders
    Hematuria
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 47 (6.38%)
    5 / 94 (5.32%)
         occurrences all number
    5
    4
    9
    Urinary retention
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 47 (4.26%)
    5 / 94 (5.32%)
         occurrences all number
    3
    2
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 47 (19.15%)
    10 / 47 (21.28%)
    19 / 94 (20.21%)
         occurrences all number
    12
    13
    25
    Back pain
         subjects affected / exposed
    15 / 47 (31.91%)
    11 / 47 (23.40%)
    26 / 94 (27.66%)
         occurrences all number
    23
    15
    38
    Pain in extremity
         subjects affected / exposed
    8 / 47 (17.02%)
    6 / 47 (12.77%)
    14 / 94 (14.89%)
         occurrences all number
    10
    8
    18
    Musculoskeletal pain
         subjects affected / exposed
    7 / 47 (14.89%)
    7 / 47 (14.89%)
    14 / 94 (14.89%)
         occurrences all number
    13
    10
    23
    Bone pain
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 47 (8.51%)
    7 / 94 (7.45%)
         occurrences all number
    4
    5
    9
    Muscle spasms
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 47 (0.00%)
    3 / 94 (3.19%)
         occurrences all number
    3
    0
    3
    Myalgia
         subjects affected / exposed
    6 / 47 (12.77%)
    4 / 47 (8.51%)
    10 / 94 (10.64%)
         occurrences all number
    7
    6
    13
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    17 / 47 (36.17%)
    9 / 47 (19.15%)
    26 / 94 (27.66%)
         occurrences all number
    26
    14
    40

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jun 2015
    Amendment 1: Protocol Vs 2.0
    11 Nov 2019
    Amendment 7: Protocol Vs 3.0
    13 Apr 2020
    Amendment 8: Protocol Vs 4.0

    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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