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    Clinical Trial Results:
    Multicentre, Single-Arm, Open-Label, Clinical Trial Intended to Provide Early Access to Cabazitaxel in Patients with Metastatic Hormone Refractory Prostate Cancer Previously Treated with a Docetaxel-Containing Regimen and to Document Safety of Cabazitaxel in These Patients

    Summary
    EudraCT number
    2010-021128-92
    Trial protocol
    GB   CZ   BE   DK   ES   IT   SE   FI   AT   PT   HU   IE   BG   SK  
    Global end of trial date
    21 Dec 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Jul 2016
    First version publication date
    24 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CABAZ_C_05331
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01254279
    WHO universal trial number (UTN)
    U1111-1115-2476
    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
    08 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To allow subjects similar to those evaluated in the TROPIC trial (EFC1693) , and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in subjects who had progressed during or after docetaxel, and to document the overall safety of cabazitaxel in these subjects.
    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
    20 Dec 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Portugal: 20
    Country: Number of subjects enrolled
    Romania: 16
    Country: Number of subjects enrolled
    Slovakia: 15
    Country: Number of subjects enrolled
    Spain: 156
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    United Kingdom: 112
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Belgium: 45
    Country: Number of subjects enrolled
    Bulgaria: 21
    Country: Number of subjects enrolled
    Czech Republic: 15
    Country: Number of subjects enrolled
    Denmark: 24
    Country: Number of subjects enrolled
    Finland: 13
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Ireland: 22
    Country: Number of subjects enrolled
    Italy: 219
    Country: Number of subjects enrolled
    Luxembourg: 1
    Country: Number of subjects enrolled
    Australia: 104
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 13
    Country: Number of subjects enrolled
    Canada: 61
    Country: Number of subjects enrolled
    Croatia: 6
    Country: Number of subjects enrolled
    India: 6
    Country: Number of subjects enrolled
    Kazakhstan: 13
    Country: Number of subjects enrolled
    Malaysia: 5
    Country: Number of subjects enrolled
    Mexico: 12
    Country: Number of subjects enrolled
    Philippines: 6
    Country: Number of subjects enrolled
    Serbia: 10
    Country: Number of subjects enrolled
    Singapore: 5
    Country: Number of subjects enrolled
    Taiwan: 23
    Worldwide total number of subjects
    981
    EEA total number of subjects
    723
    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)
    298
    From 65 to 84 years
    676
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted in 29 countries. A total of 981 subjects were enrolled between 20 December 2010 and 27 September 2013.

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

    Arms
    Arm title
    Cabazitaxel
    Arm description
    Cabazitaxel 25 mg/m² administered on Day 1 of each 3-weeks cycle in combination with prednisone or prednisolone 10 mg daily until disease progression, death, unacceptable toxicity or Investigator’s decision.
    Arm type
    Experimental

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    XRP6258
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cabazitaxel 25 mg/m² intravenous (IV) infusion administered for 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
    Started
    981
    Disease Progression
    457 [1]
    Adverse Events
    254 [2]
    Physician/Investigator's Decision
    159 [3]
    Cabazitaxel Commercially Available
    4 [4]
    Other than specified
    107 [5]
    Completed
    981
    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: Met EOT criteria (treatment until disease progression, death, unacceptable toxicity [AE], Investigator’s decision or cabazitaxel commercially available).
    [2] - 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: Met EOT criteria (treatment until disease progression, death, unacceptable toxicity [AE], Investigator’s decision or cabazitaxel commercially available).
    [3] - 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: Met EOT criteria (treatment until disease progression, death, unacceptable toxicity [AE], Investigator’s decision or cabazitaxel commercially available).
    [4] - 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: Met end of treatment (EOT) criteria (treatment until disease progression, death, unacceptable toxicity [AE], Investigator’s decision or cabazitaxel commercially available).
    [5] - 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: Met EOT criteria (treatment until disease progression, death, unacceptable toxicity [AE], Investigator’s decision or cabazitaxel commercially available).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cabazitaxel
    Reporting group description
    Cabazitaxel 25 mg/m² administered on Day 1 of each 3-weeks cycle in combination with prednisone or prednisolone 10 mg daily until disease progression, death, unacceptable toxicity or Investigator’s decision.

    Reporting group values
    Cabazitaxel Total
    Number of subjects
    981 981
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    68.2 ± 7.7 -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    981 981

    End points

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    End points reporting groups
    Reporting group title
    Cabazitaxel
    Reporting group description
    Cabazitaxel 25 mg/m² administered on Day 1 of each 3-weeks cycle in combination with prednisone or prednisolone 10 mg daily until disease progression, death, unacceptable toxicity or Investigator’s decision.

    Primary: Number of Subjects with Early Access to Cabazitaxel

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    End point title
    Number of Subjects with Early Access to Cabazitaxel [1]
    End point description
    Safety population included the subjects who had signed the informed consent form and had received at least part of one dose of cabazitaxel.
    End point type
    Primary
    End point timeframe
    From enrollment up to 30 days after the last administration of study drug (205 weeks + 30 days).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    Cabazitaxel
    Number of subjects analysed
    981
    Units: Subjects
        number (not applicable)
    981
    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
    An Adverse Event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which did not necessarily had a causal relationship with this treatment. AEs that occurred or worsened after the first day of dosing upto 30 days after the last administration of Cabazitaxel, were considered as treatment-emergent adverse events (TEAE). A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included subjects with both serious and non-serious AEs. Analysis was performed on safety population.
    End point type
    Secondary
    End point timeframe
    From enrollment upto 30 days after the last administration of study drug (205 weeks + 30 days)
    End point values
    Cabazitaxel
    Number of subjects analysed
    981
    Units: Percentage of Subjects
    number (not applicable)
        Any TEAE
    95.2
        Any possibly related TEAE
    86.2
        Any serious TEAE
    40.8
        Any TEAE leading to death
    6.6
        Any TEAE leading to treatment discontinuation
    25.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (205 weeks + 30 days) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events and death are treatment-emergent adverse events that is AEs that developed/worsened and death that occurred during the ‘on treatment period’ (the period from the first administration of study drug up to 30 days after the last administration of study drug).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Cabazitaxel
    Reporting group description
    Cabazitaxel 25 mg/m² administered on Day 1 of each 3-weeks cycle in combination with prednisone or prednisolone 10 mg daily until disease progression, death, unacceptable toxicity or Investigator’s decision.

    Serious adverse events
    Cabazitaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    400 / 981 (40.77%)
         number of deaths (all causes)
    216
         number of deaths resulting from adverse events
    Vascular disorders
    Circulatory Collapse
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    6 / 981 (0.61%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Embolism Venous
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypovolaemic Shock
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Venous Thrombosis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Venous Thrombosis Limb
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Medical Device Change
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder Cancer
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Brain Neoplasm Malignant
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastases To Lung
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastases To Central Nervous System
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastases To Spine
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Metastatic Pain
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 981 (0.61%)
         occurrences causally related to treatment / all
    5 / 7
         deaths causally related to treatment / all
    0 / 0
    Chest Pain
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Device Occlusion
         subjects affected / exposed
    5 / 981 (0.51%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    2 / 2
    Fatigue
         subjects affected / exposed
    8 / 981 (0.82%)
         occurrences causally related to treatment / all
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    Disease Progression
         subjects affected / exposed
    20 / 981 (2.04%)
         occurrences causally related to treatment / all
    0 / 22
         deaths causally related to treatment / all
    0 / 15
    General Physical Health Deterioration
         subjects affected / exposed
    9 / 981 (0.92%)
         occurrences causally related to treatment / all
    4 / 9
         deaths causally related to treatment / all
    1 / 3
    Malaise
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza Like Illness
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multi-Organ Failure
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    16 / 981 (1.63%)
         occurrences causally related to treatment / all
    5 / 16
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Pelvic Pain
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Scrotal Ulcer
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Cystitis Radiation
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur Fracture
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament Injury
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infusion Related Reaction
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal Cord Injury Cauda Equina
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Traumatic Fracture
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Haemoglobin Decreased
         subjects affected / exposed
    6 / 981 (0.61%)
         occurrences causally related to treatment / all
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    Neutrophil Count Decreased
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    White Blood Cell Count Decreased
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Platelet Count Decreased
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial Tachycardia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    4 / 981 (0.41%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Cardiac Disorder
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac Failure
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Cardiogenic Shock
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Left Ventricular Dysfunction
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiopulmonary Failure
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Myocardial Infarction
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    Supraventricular Tachycardia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Epistaxis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    7 / 981 (0.71%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    Pleural Effusion
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Artery Thrombosis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Microemboli
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    7 / 981 (0.71%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    Pulmonary Oedema
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Respiratory Failure
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    4 / 981 (0.41%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    Anaemia
         subjects affected / exposed
    12 / 981 (1.22%)
         occurrences causally related to treatment / all
    19 / 22
         deaths causally related to treatment / all
    0 / 0
    Disseminated Intravascular Coagulation
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    52 / 981 (5.30%)
         occurrences causally related to treatment / all
    58 / 58
         deaths causally related to treatment / all
    2 / 2
    Granulocytopenia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    7 / 981 (0.71%)
         occurrences causally related to treatment / all
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Neutropenia
         subjects affected / exposed
    24 / 981 (2.45%)
         occurrences causally related to treatment / all
    24 / 25
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    4 / 981 (0.41%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral Haemorrhage
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral Ischaemia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Dizziness
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Loss Of Consciousness
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Hepatic Encephalopathy
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nerve Root Compression
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraplegia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Paresis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    11 / 981 (1.12%)
         occurrences causally related to treatment / all
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal Distension
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    6 / 981 (0.61%)
         occurrences causally related to treatment / all
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    Abdominal Pain Lower
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    5 / 981 (0.51%)
         occurrences causally related to treatment / all
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    Duodenal Perforation
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    25 / 981 (2.55%)
         occurrences causally related to treatment / all
    26 / 28
         deaths causally related to treatment / all
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterovesical Fistula
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Faecal Incontinence
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Intestinal Obstruction
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Large Intestine Perforation
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Nausea
         subjects affected / exposed
    9 / 981 (0.92%)
         occurrences causally related to treatment / all
    9 / 10
         deaths causally related to treatment / all
    0 / 0
    Neutropenic Colitis
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Pancreatitis Acute
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Retching
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    12 / 981 (1.22%)
         occurrences causally related to treatment / all
    10 / 14
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic Function Abnormal
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic Failure
         subjects affected / exposed
    4 / 981 (0.41%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    1 / 3
    Hepatotoxicity
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bladder Neck Obstruction
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bladder Perforation
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    33 / 981 (3.36%)
         occurrences causally related to treatment / all
    5 / 48
         deaths causally related to treatment / all
    0 / 1
    Cystitis Haemorrhagic
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Haemorrhage Urinary Tract
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    5 / 981 (0.51%)
         occurrences causally related to treatment / all
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    Oliguria
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pollakiuria
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    12 / 981 (1.22%)
         occurrences causally related to treatment / all
    5 / 12
         deaths causally related to treatment / all
    2 / 3
    Renal Failure
         subjects affected / exposed
    4 / 981 (0.41%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    1 / 3
    Renal Impairment
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal Pain
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal Tubular Necrosis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Retention
         subjects affected / exposed
    10 / 981 (1.02%)
         occurrences causally related to treatment / all
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    Urogenital Haemorrhage
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    4 / 981 (0.41%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Back Pain
         subjects affected / exposed
    13 / 981 (1.33%)
         occurrences causally related to treatment / all
    1 / 17
         deaths causally related to treatment / all
    0 / 0
    Bone Pain
         subjects affected / exposed
    7 / 981 (0.71%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Flank Pain
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Osteonecrosis Of Jaw
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain In Extremity
         subjects affected / exposed
    4 / 981 (0.41%)
         occurrences causally related to treatment / all
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    Pain In Jaw
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Dehydration
         subjects affected / exposed
    8 / 981 (0.82%)
         occurrences causally related to treatment / all
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    Decreased Appetite
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Gout
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abdominal Sepsis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Abscess Limb
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacterial Sepsis
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Campylobacter Infection
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Candidiasis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Clostridial Infection
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device Related Infection
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterococcal Bacteraemia
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemophilus Infection
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    2 / 981 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Infectious Peritonitis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Lower Respiratory Tract Infection
         subjects affected / exposed
    8 / 981 (0.82%)
         occurrences causally related to treatment / all
    3 / 11
         deaths causally related to treatment / all
    0 / 0
    Lung Infection
         subjects affected / exposed
    3 / 981 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Necrotising Fasciitis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic Sepsis
         subjects affected / exposed
    20 / 981 (2.04%)
         occurrences causally related to treatment / all
    20 / 20
         deaths causally related to treatment / all
    1 / 1
    Neutropenic Infection
         subjects affected / exposed
    8 / 981 (0.82%)
         occurrences causally related to treatment / all
    10 / 10
         deaths causally related to treatment / all
    2 / 2
    Otitis Media
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pelvic Abscess
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Pneumonia Viral
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    16 / 981 (1.63%)
         occurrences causally related to treatment / all
    14 / 21
         deaths causally related to treatment / all
    3 / 3
    Pseudomembranous Colitis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Pseudomonas Infection
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    14 / 981 (1.43%)
         occurrences causally related to treatment / all
    10 / 16
         deaths causally related to treatment / all
    1 / 2
    Urethritis
         subjects affected / exposed
    1 / 981 (0.10%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Septic Shock
         subjects affected / exposed
    6 / 981 (0.61%)
         occurrences causally related to treatment / all
    5 / 6
         deaths causally related to treatment / all
    2 / 2
    Urosepsis
         subjects affected / exposed
    6 / 981 (0.61%)
         occurrences causally related to treatment / all
    2 / 7
         deaths causally related to treatment / all
    0 / 2
    Urinary Tract Infection
         subjects affected / exposed
    20 / 981 (2.04%)
         occurrences causally related to treatment / all
    5 / 28
         deaths causally related to treatment / all
    2 / 3
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Cabazitaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    851 / 981 (86.75%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    59 / 981 (6.01%)
         occurrences all number
    97
    Dyspnoea
         subjects affected / exposed
    56 / 981 (5.71%)
         occurrences all number
    106
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    284 / 981 (28.95%)
         occurrences all number
    864
    Leukopenia
         subjects affected / exposed
    90 / 981 (9.17%)
         occurrences all number
    142
    Neutropenia
         subjects affected / exposed
    216 / 981 (22.02%)
         occurrences all number
    368
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    100 / 981 (10.19%)
         occurrences all number
    265
    Neuropathy Peripheral
         subjects affected / exposed
    64 / 981 (6.52%)
         occurrences all number
    117
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    224 / 981 (22.83%)
         occurrences all number
    634
    Oedema Peripheral
         subjects affected / exposed
    64 / 981 (6.52%)
         occurrences all number
    130
    Fatigue
         subjects affected / exposed
    299 / 981 (30.48%)
         occurrences all number
    1018
    Pyrexia
         subjects affected / exposed
    75 / 981 (7.65%)
         occurrences all number
    87
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    57 / 981 (5.81%)
         occurrences all number
    88
    Constipation
         subjects affected / exposed
    175 / 981 (17.84%)
         occurrences all number
    364
    Diarrhoea
         subjects affected / exposed
    393 / 981 (40.06%)
         occurrences all number
    884
    Nausea
         subjects affected / exposed
    273 / 981 (27.83%)
         occurrences all number
    622
    Vomiting
         subjects affected / exposed
    184 / 981 (18.76%)
         occurrences all number
    268
    Stomatitis
         subjects affected / exposed
    67 / 981 (6.83%)
         occurrences all number
    108
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    129 / 981 (13.15%)
         occurrences all number
    248
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    121 / 981 (12.33%)
         occurrences all number
    289
    Arthralgia
         subjects affected / exposed
    78 / 981 (7.95%)
         occurrences all number
    155
    Bone Pain
         subjects affected / exposed
    81 / 981 (8.26%)
         occurrences all number
    167
    Pain In Extremity
         subjects affected / exposed
    64 / 981 (6.52%)
         occurrences all number
    115
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    192 / 981 (19.57%)
         occurrences all number
    464
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    70 / 981 (7.14%)
         occurrences all number
    113

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2010
    It included the following changes: - Title and objectives were modified in order to emphasize the objective safety. - Recruitment objectives (number of sites and subjects) were increased. - The treatment duration was harmonized throughout the protocol’s sections. - The definition of Adverse Events collection period was harmonized.
    09 Feb 2011
    It included the following changes: - Exclusion criteria was clarified. - The dosing regimen was clarified. - The use of concomitant treatment was clarified. - The data collection was clarified.
    27 Jun 2011
    It included the following changes: - Duration of treatment was prolonged if clinical benefit and no toxicity. - Chemotherapy delay/reduction was clarified. - Neutropenia management: data collection addition of the use of Granulocyte Colony-Stimulating Factor (G-CSF). - SAEs reporting was corrected. - Hematological toxicities reporting was clarified. - The Interim analysis section was updated.
    22 Dec 2011
    It included the following changes: - Exclusion criteria was clarified. - The information on preparation and administration of cabazitaxel, and storage of the premix and infusion solution was updated.

    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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