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    Clinical Trial Results:
    Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination with Prednisone for the Treatment of Metastatic Castration-Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen

    Summary
    EudraCT number
    2010-022163-35
    Trial protocol
    NL   HU   BE   ES   GB   FR   DE   PL  
    Global end of trial date
    19 Aug 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Sep 2016
    First version publication date
    03 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC11785
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01308580
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    31 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non inferiority in terms of overall survival (OS) of cabazitaxel 20 mg/m² (Arm A) versus cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in subjects with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Apr 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 20
    Country: Number of subjects enrolled
    Australia: 121
    Country: Number of subjects enrolled
    Brazil: 67
    Country: Number of subjects enrolled
    Canada: 40
    Country: Number of subjects enrolled
    Chile: 23
    Country: Number of subjects enrolled
    Korea, Republic of: 57
    Country: Number of subjects enrolled
    Peru: 28
    Country: Number of subjects enrolled
    Russian Federation: 75
    Country: Number of subjects enrolled
    South Africa: 34
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    Tunisia: 16
    Country: Number of subjects enrolled
    Turkey: 12
    Country: Number of subjects enrolled
    United States: 51
    Country: Number of subjects enrolled
    Netherlands: 47
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    Romania: 86
    Country: Number of subjects enrolled
    Spain: 86
    Country: Number of subjects enrolled
    United Kingdom: 96
    Country: Number of subjects enrolled
    Belgium: 81
    Country: Number of subjects enrolled
    France: 127
    Country: Number of subjects enrolled
    Germany: 41
    Country: Number of subjects enrolled
    Hungary: 50
    Worldwide total number of subjects
    1200
    EEA total number of subjects
    644
    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)
    362
    From 65 to 84 years
    830
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    Study was conducted at 172 centers in 22 countries.

    Pre-assignment
    Screening details
    A total of 1463 subjects were screened between 19 April 2011 and 18 November 2013. Out of 1463 subjects, 1200 were enrolled in study and 263 were not eligible to join study. Subjects were randomized by Interactive Voice Response System (IVRS) in 1:1 ratio (Cabazitaxel 20 mg/m²: Cabazitaxel 25 mg/m²).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cabazitaxel 20 mg/m²
    Arm description
    Cabazitaxel 20 mg/m² on Day 1 of each 21-day cycle in combination with prednisone or prednisolone 10 mg orally daily until DP, unacceptable toxicity, subject’s refusal of further study treatment or for a maximum of 10 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    XRP6258
    Other name
    Jevtana®
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cabazitaxel 20 mg/m² intravenous (IV) infusion over one hour.

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone or prednisolone 10 mg daily administered according to its labelling.

    Arm title
    Cabazitaxel 25 mg/m²
    Arm description
    Cabazitaxel 25 mg/m²on Day 1 of each 21-day cycle in combination with prednisone or prednisolone 10 mg orally daily until DP, unacceptable toxicity, subject’s refusal of further study treatment or for a maximum of 10 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    XRP6258
    Other name
    Jevtana®
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cabazitaxel 25 mg/m² IV infusion over one hour.

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone or prednisolone 10 mg daily administered according to its labelling.

    Number of subjects in period 1
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Started
    598
    602
    Treated
    587
    588 [1]
    Completed
    586
    595
    Not completed
    12
    7
         Lost to follow-up
             12
             7
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: By EudraCT Results Validation Rules warning is intended to state: “It is expected the number of subjects will be greater than, or equal to the number that started minus those that left.” Completed group = subjects with survival follow-up until death/end of study (randomized minus lost to follow-up). Completed subjects included those who withdrew treatment consent but agreed to be followed for survival. Treated subjects appear by random assignment, was not actual treatment received in some cases.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cabazitaxel 20 mg/m²
    Reporting group description
    Cabazitaxel 20 mg/m² on Day 1 of each 21-day cycle in combination with prednisone or prednisolone 10 mg orally daily until DP, unacceptable toxicity, subject’s refusal of further study treatment or for a maximum of 10 cycles.

    Reporting group title
    Cabazitaxel 25 mg/m²
    Reporting group description
    Cabazitaxel 25 mg/m²on Day 1 of each 21-day cycle in combination with prednisone or prednisolone 10 mg orally daily until DP, unacceptable toxicity, subject’s refusal of further study treatment or for a maximum of 10 cycles.

    Reporting group values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m² Total
    Number of subjects
    598 602 1200
    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)
    182 180 362
        From 65-84 years
    412 418 830
        85 years and over
    4 4 8
    Gender categorical
    Units: Subjects
        Female
    0 0 0
        Male
    598 602 1200

    End points

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    End points reporting groups
    Reporting group title
    Cabazitaxel 20 mg/m²
    Reporting group description
    Cabazitaxel 20 mg/m² on Day 1 of each 21-day cycle in combination with prednisone or prednisolone 10 mg orally daily until DP, unacceptable toxicity, subject’s refusal of further study treatment or for a maximum of 10 cycles.

    Reporting group title
    Cabazitaxel 25 mg/m²
    Reporting group description
    Cabazitaxel 25 mg/m²on Day 1 of each 21-day cycle in combination with prednisone or prednisolone 10 mg orally daily until DP, unacceptable toxicity, subject’s refusal of further study treatment or for a maximum of 10 cycles.

    Primary: Overall Survival (OS)

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    End point title
    Overall Survival (OS)
    End point description
    OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the subject was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method. Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized subjects.
    End point type
    Primary
    End point timeframe
    From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    598
    602
    Units: months
        median (confidence interval 95%)
    13.4 (12.19 to 14.88)
    14.5 (13.47 to 15.28)
    Statistical analysis title
    HR Cabazitaxel 20 mg/m² vs Cabazitaxel 25 mg/m²
    Statistical analysis description
    Hazard ratio (HR) for OS was estimated using Cox proportional hazards regression model. This model was adjusted by measurability of disease at baseline, Eastern Cooperative Oncology Group performance status (ECOG PS) score at baseline, & region at the time of randomization. Cabazitaxel 20 mg/m² relative to 25 mg/m² dose group was considered non-inferior if upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m² versus 25 mg/m²) was less than non-inferiority margin of 1.214.
    Comparison groups
    Cabazitaxel 20 mg/m² v Cabazitaxel 25 mg/m²
    Number of subjects included in analysis
    1200
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.024
    Confidence interval
         level
    98.89%
         sides
    1-sided
         lower limit
    -
         upper limit
    1.184
    Notes
    [1] - Non-inferiority margin of 1.214
    Statistical analysis title
    HR Cabazitaxel 20 mg/m² vs Cabazitaxel 25 mg/m²
    Statistical analysis description
    The HR for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m² was considered to be superior to 20 mg/m² dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.
    Comparison groups
    Cabazitaxel 20 mg/m² v Cabazitaxel 25 mg/m²
    Number of subjects included in analysis
    1200
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.024
    Confidence interval
         level
    95%
         sides
    1-sided
         lower limit
    0.922
         upper limit
    -

    Secondary: Progression Free Survival (PFS)

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    End point title
    Progression Free Survival (PFS)
    End point description
    PFS was evaluated from the date of randomization to the date of the first documentation of any of the following events: Radiological tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1); Prostate-Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method. ITT population.
    End point type
    Secondary
    End point timeframe
    From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    598
    602
    Units: months
        median (confidence interval 95%)
    2.9 (2.79 to 3.45)
    3.5 (3.12 to 3.94)
    Statistical analysis title
    HR Cabazitaxel 20 mg/m² vs Cabazitaxel 25 mg/m²
    Statistical analysis description
    HR was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.
    Comparison groups
    Cabazitaxel 20 mg/m² v Cabazitaxel 25 mg/m²
    Number of subjects included in analysis
    1200
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.099
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.974
         upper limit
    1.24

    Secondary: Time to Tumor Progression

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    End point title
    Time to Tumor Progression
    End point description
    Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Analysis was performed by Kaplan-Meier method. ITT population.
    End point type
    Secondary
    End point timeframe
    From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    598
    602
    Units: months
        median (confidence interval 95%)
    9 (8.38 to 9.79)
    9.3 (8.61 to 9.92)
    Statistical analysis title
    HR Cabazitaxel 20 mg/m² vs Cabazitaxel 25 mg/m²
    Statistical analysis description
    HR was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.
    Comparison groups
    Cabazitaxel 20 mg/m² v Cabazitaxel 25 mg/m²
    Number of subjects included in analysis
    1200
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.096
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.902
         upper limit
    1.331

    Secondary: Percentage of Subjects With Overall Objective Tumor Response

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    End point title
    Percentage of Subjects With Overall Objective Tumor Response
    End point description
    Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ITT population. Number of subjects analyzed= subjects evaluable for tumor response with measurable disease at baseline and at least one valid post baseline value.
    End point type
    Secondary
    End point timeframe
    From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    271
    256
    Units: percentage of subjects
        number (confidence interval 95%)
    18.5 (13.8 to 23.1)
    23.4 (18.2 to 28.6)
    No statistical analyses for this end point

    Secondary: Time to PSA Progression

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    End point title
    Time to PSA Progression
    End point description
    Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of >25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In subjects not eligible for PSA response (baseline PSA <10 ng/mL): (a) subjects with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) subjects with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method. ITT population.
    End point type
    Secondary
    End point timeframe
    From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    598
    602
    Units: months
        median (confidence interval 95%)
    5.7 (4.96 to 6.47)
    6.8 (6.11 to 7.46)
    Statistical analysis title
    HR Cabazitaxel 20 mg/m² vs Cabazitaxel 25 mg/m²
    Statistical analysis description
    HR was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.
    Comparison groups
    Cabazitaxel 20 mg/m² v Cabazitaxel 25 mg/m²
    Number of subjects included in analysis
    1200
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.195
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.025
         upper limit
    1.393

    Secondary: Percentage of Subjects With PSA Response

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    End point title
    Percentage of Subjects With PSA Response
    End point description
    PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in subjects with baseline PSA value ≥10 ng/mL. ITT population. Number of subjects analyzed= subjects evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post baseline value.
    End point type
    Secondary
    End point timeframe
    From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    543
    538
    Units: percentage of subjects
        number (confidence interval 95%)
    29.5 (25.6 to 33.3)
    42.9 (38.8 to 47.1)
    No statistical analyses for this end point

    Secondary: Time to Pain Progression

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    End point title
    Time to Pain Progression
    End point description
    Pain Progression was defined as an increase of ≥1 point in the median Present Pain Intensity (PPI) from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score (AS) compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by subject in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excruciating. Analgesic use was recorded by the subject in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method. ITT population.
    End point type
    Secondary
    End point timeframe
    From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    598
    602
    Units: months
        median (confidence interval 95%)
    6.2 (5.22 to 7.39)
    6.4 (5.55 to 7.26)
    Statistical analysis title
    HR Cabazitaxel 20 mg/m² vs Cabazitaxel 25 mg/m²
    Statistical analysis description
    HR was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.
    Comparison groups
    Cabazitaxel 20 mg/m² v Cabazitaxel 25 mg/m²
    Number of subjects included in analysis
    1200
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.046
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.874
         upper limit
    1.251

    Secondary: Percentage of Subjects With Pain Response

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    End point title
    Percentage of Subjects With Pain Response
    End point description
    Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increase in pain during the first 12 weeks were ignored in determining pain response. ITT population. Number of subjects analyzed= subjects evaluable for pain response with pain score with median PPI ≥2 and/or mean AS ≥10 points at baseline and at least one valid post baseline value.
    End point type
    Secondary
    End point timeframe
    From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    248
    284
    Units: percentage of subjects
        number (confidence interval 95%)
    34.7 (28.8 to 40.6)
    37.3 (31.7 to 42.9)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P): Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)

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    End point title
    Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P): Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)
    End point description
    FACT-P is a 39-item subject questionnaire that measures the concerns of subjects with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Trial Outcome Index combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0-104, where higher values represent better HRQoL. Analysis was performed on Fact-P population that included randomized subjects who completed FACT-P questionnaire at baseline & in at least one post baseline assessment. Number of subjects analyzed= subjects with evaluable FACT-P TOI for specified outcome measure. Here, 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    521
    494
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Cycle 1 (n=521, 494)
    4.69 (2.95 to 6.44)
    5.08 (3.32 to 6.84)
        Change at cycle 2 (n = 500, 494)
    4.4 (2.67 to 6.14)
    5.55 (3.81 to 7.3)
        Change at Cycle 3 (n=456, 451)
    3.75 (2 to 5.5)
    5.46 (3.7 to 7.23)
        Change at Cycle 4 (n=420, 415)
    2.57 (0.8 to 4.33)
    3.82 (2.04 to 5.6)
        Change at Cycle 5 (n=339, 361)
    1.78 (-0.03 to 3.59)
    3.06 (1.26 to 4.87)
        Change at Cycle 6 (n=275, 318)
    2.57 (0.72 to 4.43)
    2.03 (0.2 to 3.86)
        Change at Cycle 7 (n=225, 262)
    2.51 (0.6 to 4.42)
    2.73 (0.85 to 4.6)
        Change at Cycle 8 (n=196, 227)
    1.44 (-0.5 to 3.39)
    2.08 (0.16 to 3.99)
        Change at Cycle 9 (n=165, 172)
    0.94 (-1.06 to 2.94)
    1.46 (-0.55 to 3.46)
        Change at Cycle 10 (n=137, 141)
    0.02 (-2.05 to 2.1)
    1.31 (-0.76 to 3.39)
        Change at Follow-up 1 (n=136, 152)
    -2.27 (-4.35 to -0.19)
    -1.16 (-3.21 to 0.88)
    No statistical analyses for this end point

    Secondary: Change From Baseline in FACT-P: Total Score as a Measure of HRQoL

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    End point title
    Change From Baseline in FACT-P: Total Score as a Measure of HRQoL
    End point description
    FACT-P is a 39-item subject questionnaire that measures the concerns of subjects with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Fact-P population. Number of subjects analyzed= subjects with evaluable FACT-P Total Score for specified outcome measure. Here, 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    521
    495
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Cycle 1 (n=521, 495)
    5.6 (3.43 to 7.78)
    5.75 (3.55 to 7.95)
        Change at Cycle 2 (n=502, 492)
    5.39 (3.23 to 7.55)
    6.23 (4.05 to 8.42)
        Change at Cycle 3 (n=459, 452)
    4.39 (2.21 to 6.57)
    6.09 (3.89 to 8.3)
        Change at Cycle 4 (n=421, 415)
    2.94 (0.73 to 5.14)
    4.2 (1.98 to 6.42)
        Change at Cycle 5 (n=339, 365)
    1.79 (-0.46 to 4.04)
    3.33 (1.08 to 5.59)
        Change at Cycle 6 (n=275, 320)
    2.57 (0.26 to 4.88)
    2.35 (0.06 to 4.64)
        Change at Cycle 7 (n=229, 267)
    2.62 (0.25 to 4.99)
    2.72 (0.38 to 5.06)
        Change at Cycle 8 (n=196, 226)
    1.35 (-1.08 to 3.78)
    1.98 (-0.42 to 4.37)
        Change at Cycle 9 (n=164, 172)
    1.1 (-1.4 to 3.6)
    1 (-1.5 to 3.51)
        Change at Cycle 10 (n=137, 141)
    0.02 (-2.57 to 2.61)
    1.33 (-1.26 to 3.93)
        Change at Follow-up 1 (n=137, 153)
    -3.1 (-5.69 to -0.51)
    -2.09 (-4.65 to 0.46)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With FACT-P Total Score Response

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    End point title
    Percentage of Subjects With FACT-P Total Score Response
    End point description
    FACT-P is a 39-item subject questionnaire that measures the concerns of subjects with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period. Fact-P population. Number of subjects analyzed= subjects with evaluable FACT-P total score for specified outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    540
    525
    Units: percentage of subjects
        number (confidence interval 95%)
    57.2 (53 to 61.4)
    59.4 (55.2 to 63.6)
    No statistical analyses for this end point

    Secondary: Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales

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    End point title
    Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales
    End point description
    The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method. Fact-P population.
    End point type
    Secondary
    End point timeframe
    From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    557
    543
    Units: months
    median (confidence interval 95%)
        Physical well-being
    6.6 (5.85 to 7.82)
    8.3 (7.16 to 8.74)
        Social/family well-being
    10.8 (9.26 to 13.37)
    12.4 (8.97 to 13.83)
        Emotional well-being
    9.7 (7.36 to 11.3)
    9.9 (8.54 to 12.52)
        Functional well-being
    6.6 (5.55 to 7.43)
    6.7 (6.01 to 8.34)
        Prostate specific concern
    8.7 (7.62 to 9.66)
    9.7 (8.77 to 10.87)
    No statistical analyses for this end point

    Secondary: Time to Definitive Deterioration of ECOG PS Score From Baseline

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    End point title
    Time to Definitive Deterioration of ECOG PS Score From Baseline
    End point description
    The ECOG PS was used to evaluate subject's DP and the effect of the disease on the subject's activities of daily living. Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method. ITT population.
    End point type
    Secondary
    End point timeframe
    From baseline until death or study cut-off date (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    598
    602
    Units: months
        median (confidence interval 95%)
    14.9 (11.43 to 23.59)
    14.1 (12.22 to 20.17)
    No statistical analyses for this end point

    Secondary: Time to Definitive Weight Loss by 5% and 10% From Baseline

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    End point title
    Time to Definitive Weight Loss by 5% and 10% From Baseline
    End point description
    Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method. ITT population. Here, 99999 signifies that median and upper bound of the confidence interval of Cabazitaxel 20 mg/m² arm and upper bound of the confidence interval of Cabazitaxel 25 mg/m² arm for weight loss by 10% could not be calculated using the Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    From baseline until death or study cut-off date (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    598
    602
    Units: months
    median (confidence interval 95%)
        Weight Loss by 5%
    10.6 (9.26 to 13.17)
    11.1 (10.12 to 12.42)
        Weight Loss by 10%
    99999 (12.65 to 99999)
    20.3 (14.23 to 99999)
    No statistical analyses for this end point

    Secondary: Time to First Definitive Consumption of Narcotic Medication

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    End point title
    Time to First Definitive Consumption of Narcotic Medication
    End point description
    Concomitant medications used were recorded for all subjects, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method. ITT population.
    End point type
    Secondary
    End point timeframe
    From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    598
    602
    Units: months
        median (confidence interval 95%)
    2.2 (0.99 to 3.65)
    0.8 (0.3 to 2.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment-emergent Adverse Events (TEAE)

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    End point title
    Percentage of Subjects With Treatment-emergent Adverse Events (TEAE)
    End point description
    Any untoward medical occurrence in a subject receiving investigational medicinal product was considered an adverse event (AE) without regard to possibility of causal relationship with treatment. TEAEs: AEs developed/worsened/became serious during on-treatment period (time from first dose of treatment to 30 days after last dose of treatment [either Cabazitaxel or Prednisone]).Serious adverse event (SAE):any untoward medical occurrence resulted in any of following: death,life-threatening,required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered medically important event. Any TEAE included subjects with both SAE and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) v.4.03 (Grade 3=severe; Grade 4=life-threatening) was used to grade clinical AEs. Safety population included all randomized subjects who received ≥1 dose of study drug during study treatment period.
    End point type
    Secondary
    End point timeframe
    From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    580
    595
    Units: percentage of subjects
    number (not applicable)
        Any Grade TEAE
    91.2
    93.9
        Any Grade 3-4 TEAE
    39.7
    54.5
        Grade 3-4 TEAE excluding laboratory TEAE
    35.7
    48.1
        Grade 3-4 TEAE excluding DP TEAEs
    39
    53.9
        Grade 3-4 TEAE excluding laboratory and DP TEAEs
    35
    47.4
        Any Serious TEAE
    30.5
    43.2
        Any TEAE leading to permanent discontinuation
    16.4
    19.5
    No statistical analyses for this end point

    Secondary: Plasma Clearance (CL) for Cabazitaxel

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    End point title
    Plasma Clearance (CL) for Cabazitaxel
    End point description
    Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study subjects (approximately 150 subjects/group, by protocol) according to a sparse sampling strategy. Analysis was performed on PK population that included subjects who had evaluable PK data. Number of subjects analyzed = subjects with PK assessment at specified time-points.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    133
    166
    Units: Litre/hour
        arithmetic mean (standard deviation)
    44.832 ± 15.075
    49.662 ± 17.613
    No statistical analyses for this end point

    Secondary: Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel

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    End point title
    Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel
    End point description
    Blood samples for PK analysis were obtained from a subset of the study subjects (approximately 150 subjects/group, by protocol) according to a sparse sampling strategy. PK population. Number of subjects analyzed= subjects with PK assessment at specified time-points.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI
    End point values
    Cabazitaxel 20 mg/m² Cabazitaxel 25 mg/m²
    Number of subjects analysed
    133
    166
    Units: litre
        arithmetic mean (standard deviation)
    7381.46 ± 4488.72
    7040.1 ± 5133.12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were collected from signature of the informed consent form up to the final visit (48 months) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs and deaths are TEAEs that is AEs that developed/worsened and death that occurred during the ‘on treatment period’ (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Cabazitaxel 25 mg/m²
    Reporting group description
    Cabazitaxel 25 mg/m² on Day 1 of each 21-day cycle in combination with prednisone or prednisolone 10 mg orally daily until DP, unacceptable toxicity, subject’s refusal of further study treatment or for a maximum of 10 cycles.

    Reporting group title
    Cabazitaxel 20 mg/m²
    Reporting group description
    Cabazitaxel 20 mg/m² on Day 1 of each 21-day cycle in combination with prednisone or prednisolone 10 mg orally daily until DP, unacceptable toxicity, subject’s refusal of further study treatment or for a maximum of 10 cycles.

    Serious adverse events
    Cabazitaxel 25 mg/m² Cabazitaxel 20 mg/m²
    Total subjects affected by serious adverse events
         subjects affected / exposed
    257 / 595 (43.19%)
    177 / 580 (30.52%)
         number of deaths (all causes)
    497
    487
         number of deaths resulting from adverse events
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    3 / 595 (0.50%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism Venous
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous Thrombosis Limb
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic Shock
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder Cancer
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Carcinoma
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer Pain
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Central Nervous System
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases To Spine
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Pain
         subjects affected / exposed
    1 / 595 (0.17%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour Associated Fever
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Catheter Site Inflammation
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    4 / 595 (0.67%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Occlusion
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Discomfort
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Fatigue
         subjects affected / exposed
    5 / 595 (0.84%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    4 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease Progression
         subjects affected / exposed
    13 / 595 (2.18%)
    8 / 580 (1.38%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 8
    0 / 8
    Malaise
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    2 / 595 (0.34%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion Site Extravasation
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    6 / 595 (1.01%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    3 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Cardiac Death
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sudden Death
         subjects affected / exposed
    2 / 595 (0.34%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic Attack
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic Pain
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema Genital
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical Cystitis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis Radiation
         subjects affected / exposed
    4 / 595 (0.67%)
    4 / 580 (0.69%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured Sacrum
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-Traumatic Pain
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Radiation
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation Proctitis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    0 / 595 (0.00%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Anastomotic Leak
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood Creatinine Increased
         subjects affected / exposed
    2 / 595 (0.34%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil Count Decreased
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases Increased
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    3 / 595 (0.50%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    2 / 595 (0.34%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiorenal Syndrome
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 595 (0.50%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    2 / 595 (0.34%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Consolidation
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    0 / 595 (0.00%)
    3 / 580 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    8 / 595 (1.34%)
    7 / 580 (1.21%)
         occurrences causally related to treatment / all
    2 / 8
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    3 / 595 (0.50%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    12 / 595 (2.02%)
    13 / 580 (2.24%)
         occurrences causally related to treatment / all
    8 / 13
    9 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated Intravascular Coagulation
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Febrile Bone Marrow Aplasia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    48 / 595 (8.07%)
    10 / 580 (1.72%)
         occurrences causally related to treatment / all
    48 / 48
    10 / 10
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic Uraemic Syndrome
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    27 / 595 (4.54%)
    3 / 580 (0.52%)
         occurrences causally related to treatment / all
    26 / 28
    3 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    3 / 595 (0.50%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral Haematoma
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ataxia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Haemorrhage
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypoaesthesia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Lumbosacral Plexopathy
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve Compression
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Sensorimotor Neuropathy
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Motor Neuropathy
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    6 / 595 (1.01%)
    6 / 580 (1.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 595 (0.00%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual Acuity Reduced
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    3 / 595 (0.50%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    5 / 595 (0.84%)
    5 / 580 (0.86%)
         occurrences causally related to treatment / all
    4 / 5
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 595 (0.00%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    13 / 595 (2.18%)
    5 / 580 (0.86%)
         occurrences causally related to treatment / all
    14 / 15
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Diverticular Perforation
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Diverticulum Intestinal Haemorrhagic
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    3 / 595 (0.50%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive Oesophagitis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical Fistula
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Ischaemia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus Paralytic
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Intestinal Haemorrhage
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric Vein Thrombosis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 595 (0.50%)
    3 / 580 (0.52%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic Colitis
         subjects affected / exposed
    2 / 595 (0.34%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    2 / 595 (0.34%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    2 / 595 (0.34%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    5 / 595 (0.84%)
    7 / 580 (1.21%)
         occurrences causally related to treatment / all
    4 / 7
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    6 / 595 (1.01%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Azotaemia
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis Haemorrhagic
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis Noninfective
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 595 (0.00%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    7 / 595 (1.18%)
    6 / 580 (1.03%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    21 / 595 (3.53%)
    13 / 580 (2.24%)
         occurrences causally related to treatment / all
    9 / 23
    8 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    0 / 595 (0.00%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ureteric Obstruction
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Bladder Toxicity
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Incontinence
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Inflammation
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    6 / 595 (1.01%)
    6 / 580 (1.03%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Failure
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Obstruction
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 595 (0.84%)
    3 / 580 (0.52%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    5 / 595 (0.84%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank Pain
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Pain
         subjects affected / exposed
    8 / 595 (1.34%)
    4 / 580 (0.69%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Haemorrhage
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    2 / 595 (0.34%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck Pain
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain In Extremity
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    4 / 595 (0.67%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Pain
         subjects affected / exposed
    0 / 595 (0.00%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral Foraminal Stenosis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    2 / 595 (0.34%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 595 (0.17%)
    3 / 580 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Amoebic Dysentery
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Infection
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridial Infection
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Infective
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Bacteraemia
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Related Infection
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile Infection
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Escherichia Sepsis
         subjects affected / exposed
    2 / 595 (0.34%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Listeriosis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 595 (0.00%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Abscess
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic Infection
         subjects affected / exposed
    17 / 595 (2.86%)
    8 / 580 (1.38%)
         occurrences causally related to treatment / all
    17 / 18
    8 / 9
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Lymphangitis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic Sepsis
         subjects affected / exposed
    14 / 595 (2.35%)
    7 / 580 (1.21%)
         occurrences causally related to treatment / all
    14 / 14
    7 / 7
         deaths causally related to treatment / all
    3 / 3
    2 / 2
    Pelvic Abscess
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis Infective
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    7 / 595 (1.18%)
    6 / 580 (1.03%)
         occurrences causally related to treatment / all
    4 / 7
    4 / 7
         deaths causally related to treatment / all
    1 / 2
    1 / 1
    Peritonitis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 595 (0.34%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    2 / 595 (0.34%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Infection
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    7 / 595 (1.18%)
    5 / 580 (0.86%)
         occurrences causally related to treatment / all
    5 / 7
    4 / 5
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Sinusitis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    5 / 595 (0.84%)
    4 / 580 (0.69%)
         occurrences causally related to treatment / all
    4 / 5
    2 / 4
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Staphylococcal Bacteraemia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 580 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    17 / 595 (2.86%)
    9 / 580 (1.55%)
         occurrences causally related to treatment / all
    6 / 17
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 595 (0.00%)
    2 / 580 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection Staphylococcal
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 580 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    2 / 595 (0.34%)
    3 / 580 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Cabazitaxel 25 mg/m² Cabazitaxel 20 mg/m²
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    507 / 595 (85.21%)
    450 / 580 (77.59%)
    Injury, poisoning and procedural complications
    Wrong Technique In Drug Usage Process
         subjects affected / exposed
    32 / 595 (5.38%)
    2 / 580 (0.34%)
         occurrences all number
    37
    2
    Investigations
    Weight Decreased
         subjects affected / exposed
    44 / 595 (7.39%)
    24 / 580 (4.14%)
         occurrences all number
    45
    24
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    43 / 595 (7.23%)
    29 / 580 (5.00%)
         occurrences all number
    52
    31
    Cough
         subjects affected / exposed
    35 / 595 (5.88%)
    34 / 580 (5.86%)
         occurrences all number
    37
    36
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    40 / 595 (6.72%)
    15 / 580 (2.59%)
         occurrences all number
    46
    16
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    63 / 595 (10.59%)
    41 / 580 (7.07%)
         occurrences all number
    87
    48
    Dizziness
         subjects affected / exposed
    32 / 595 (5.38%)
    24 / 580 (4.14%)
         occurrences all number
    37
    24
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    63 / 595 (10.59%)
    38 / 580 (6.55%)
         occurrences all number
    73
    39
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    114 / 595 (19.16%)
    88 / 580 (15.17%)
         occurrences all number
    164
    119
    Fatigue
         subjects affected / exposed
    156 / 595 (26.22%)
    142 / 580 (24.48%)
         occurrences all number
    201
    161
    Oedema Peripheral
         subjects affected / exposed
    53 / 595 (8.91%)
    38 / 580 (6.55%)
         occurrences all number
    64
    40
    Pyrexia
         subjects affected / exposed
    32 / 595 (5.38%)
    26 / 580 (4.48%)
         occurrences all number
    38
    30
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    48 / 595 (8.07%)
    29 / 580 (5.00%)
         occurrences all number
    66
    33
    Constipation
         subjects affected / exposed
    107 / 595 (17.98%)
    102 / 580 (17.59%)
         occurrences all number
    150
    130
    Diarrhoea
         subjects affected / exposed
    231 / 595 (38.82%)
    175 / 580 (30.17%)
         occurrences all number
    442
    318
    Vomiting
         subjects affected / exposed
    105 / 595 (17.65%)
    78 / 580 (13.45%)
         occurrences all number
    176
    104
    Stomatitis
         subjects affected / exposed
    30 / 595 (5.04%)
    27 / 580 (4.66%)
         occurrences all number
    35
    30
    Nausea
         subjects affected / exposed
    188 / 595 (31.60%)
    140 / 580 (24.14%)
         occurrences all number
    304
    192
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    24 / 595 (4.03%)
    31 / 580 (5.34%)
         occurrences all number
    25
    34
    Haematuria
         subjects affected / exposed
    108 / 595 (18.15%)
    73 / 580 (12.59%)
         occurrences all number
    152
    90
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    36 / 595 (6.05%)
    15 / 580 (2.59%)
         occurrences all number
    36
    15
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    37 / 595 (6.22%)
    46 / 580 (7.93%)
         occurrences all number
    44
    54
    Pain In Extremity
         subjects affected / exposed
    40 / 595 (6.72%)
    30 / 580 (5.17%)
         occurrences all number
    48
    34
    Back Pain
         subjects affected / exposed
    78 / 595 (13.11%)
    63 / 580 (10.86%)
         occurrences all number
    92
    68
    Bone Pain
         subjects affected / exposed
    42 / 595 (7.06%)
    42 / 580 (7.24%)
         occurrences all number
    45
    57
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    108 / 595 (18.15%)
    74 / 580 (12.76%)
         occurrences all number
    138
    91
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    51 / 595 (8.57%)
    33 / 580 (5.69%)
         occurrences all number
    70
    35

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2010
    Amendment 1: It included the following changes: - Removed the body surface area (BSA) capping at 2.1 m² for the calculation of the dose, following the Food and Drug Association (FDA) request. Based on FDA review of the EFC6193 trial, subjects whose BSA was greater than 2.1 m² and did not had their cabazitaxel dose capped had a lower rate of >Grade 3 neutropenia compared to subjects with BSA greater than 2.1 m² and dose-capping and to subjects with BSA <2.1 m².
    10 Mar 2011
    Amendment 2: It included the following changes: - Implemented the recommendations made by the renal expert board. - Added pharmacogenomics for subjects with PK in selected site. - Included an exploratory objective to evaluate circulating free plasma DNA (total and tumor specific) for biomarker studies in selected sites. - Updated the Written Subject Information in order to reflect the changes within the protocol.
    14 Dec 2011
    Amendment 3: It included the following changes: - Allowed premedication with oral antihistamines in countries where no intravenous formulation was available. - Incorporated updated information on preparation and administration of cabazitaxel, and storage of the premix and infusion solution according to Investigational Brochure edition 13.

    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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