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    Clinical Trial Results:
    A Pilot, Exploratory, Randomized, Phase 2 Safety Study Evaluating Tumor Cell (Plasma Cell) Mobilization and Apheresis Product Contamination in Plerixafor Plus Non-Pegylated Granulocyte Colony-Stimulating Factor (G-CSF) Mobilized Patients and in Non-Pegylated G-CSF Alone Mobilized Patients

    Summary
    EudraCT number
    2011-004783-30
    Trial protocol
    BE   LT   SE   EE  
    Global end of trial date
    28 Sep 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARD12858-MOZ23510
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01753453
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi Genzyme Corporation
    Sponsor organisation address
    500 Kendall Street , Cambridge, MA, United States, 02142
    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
    18 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate tumor cell mobilization (TCM) with non-pegylated granulocyte colony-stimulating factor (G-CSF) alone compared with non-pegylated G-CSF plus plerixafor in subjects with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).
    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
    04 Jun 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    Estonia: 5
    Country: Number of subjects enrolled
    Lithuania: 7
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    13
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 5 centres in 3 countries. A total of 28 subjects were screened between 4 June 2013 and 28 September 2016, of whom 20 subjects were randomized in the study.

    Pre-assignment
    Screening details
    Subjects were randomized in 1:1 ratio to receive either G-CSF alone or G-CSF plus plerixafor.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    G-CSF Alone
    Arm description
    G-CSF (non-pegylated only) 10 mcg/kg once daily (qd) in the morning for 5 consecutive days. Morning doses of G-CSF was followed by apheresis and continued for up to a maximum of 4 apheresis or until >=6*10^6 CD34+ cells/kg were collected.
    Arm type
    Non-Investigational Medicinal Product (IMP)

    Investigational medicinal product name
    Non-IMP: Granulocyte Colony-Stimulating Factor (G-CSF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The dose of G-CSF was based on the subject’s actual body weight and G-CSF was administered approximately 1 hour prior to apheresis.

    Arm title
    G-CSF + Plerixafor
    Arm description
    G-CSF (non-pegylated only) 10 mcg/kg qd in the morning for 4 consecutive days, Plerixafor 240 mcg/kg in the evening of Day 4, and G-CSF (non-pegylated only) 10 mcg/kg in the morning on Day 5. Evening doses of plerixafor and morning doses of G-CSF was followed by apheresis and continued for up to a maximum of 4 apheresis or until >=6*10^6 CD34+ cells/kg were collected.
    Arm type
    Experimental

    Investigational medicinal product name
    Non IMP: Granulocyte Colony-Stimulating Factor (G-CSF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The dose of G-CSF was based on the subject’s actual body weight and G-CSF was administered approximately 1 hour prior to apheresis.

    Investigational medicinal product name
    Plerixafor
    Investigational medicinal product code
    AMD3100
    Other name
    Mozobil®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Plerixafor 240 mcg/kg was administered 10 to 11 hours prior to the initiation of apheresis.

    Number of subjects in period 1
    G-CSF Alone G-CSF + Plerixafor
    Started
    10
    10
    Completed
    9
    10
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    G-CSF Alone
    Reporting group description
    G-CSF (non-pegylated only) 10 mcg/kg once daily (qd) in the morning for 5 consecutive days. Morning doses of G-CSF was followed by apheresis and continued for up to a maximum of 4 apheresis or until >=6*10^6 CD34+ cells/kg were collected.

    Reporting group title
    G-CSF + Plerixafor
    Reporting group description
    G-CSF (non-pegylated only) 10 mcg/kg qd in the morning for 4 consecutive days, Plerixafor 240 mcg/kg in the evening of Day 4, and G-CSF (non-pegylated only) 10 mcg/kg in the morning on Day 5. Evening doses of plerixafor and morning doses of G-CSF was followed by apheresis and continued for up to a maximum of 4 apheresis or until >=6*10^6 CD34+ cells/kg were collected.

    Reporting group values
    G-CSF Alone G-CSF + Plerixafor Total
    Number of subjects
    10 10 20
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.3 ± 9.06 59.1 ± 8.77 -
    Gender categorical
    Units: Subjects
        Female
    4 6 10
        Male
    6 4 10

    End points

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    End points reporting groups
    Reporting group title
    G-CSF Alone
    Reporting group description
    G-CSF (non-pegylated only) 10 mcg/kg once daily (qd) in the morning for 5 consecutive days. Morning doses of G-CSF was followed by apheresis and continued for up to a maximum of 4 apheresis or until >=6*10^6 CD34+ cells/kg were collected.

    Reporting group title
    G-CSF + Plerixafor
    Reporting group description
    G-CSF (non-pegylated only) 10 mcg/kg qd in the morning for 4 consecutive days, Plerixafor 240 mcg/kg in the evening of Day 4, and G-CSF (non-pegylated only) 10 mcg/kg in the morning on Day 5. Evening doses of plerixafor and morning doses of G-CSF was followed by apheresis and continued for up to a maximum of 4 apheresis or until >=6*10^6 CD34+ cells/kg were collected.

    Primary: Percentage of Myeloma Tumor Cells/CD34+ Cell Count in Peripheral Blood

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    End point title
    Percentage of Myeloma Tumor Cells/CD34+ Cell Count in Peripheral Blood [1]
    End point description
    The presence of myeloma tumor cells in peripheral blood was detected by flow cytometry analysis. Overall data from Day 5 pre-G-CSF administration up to Day 8 pre-G-CSF administration was calculated as sum of total myeloma tumors cells count/total CD34+ cells count from Day 5 up to Day 8. Analysis was performed on ITT population defined as all randomized population analyzed according to the treatment group allocated by randomization regardless of whether subjects received any study drug or received a different study drug from which they were randomized.
    End point type
    Primary
    End point timeframe
    Day 5 up to Day 8
    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
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: percentage of myeloma tumor cells
        arithmetic mean (standard deviation)
    0 ± 0
    0 ± 0
    No statistical analyses for this end point

    Primary: Percentage of Myeloma Tumor Cells/CD34+ Cells Count Per Cumulative G-CSF Dose (mcg/kg) in Peripheral Blood

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    End point title
    Percentage of Myeloma Tumor Cells/CD34+ Cells Count Per Cumulative G-CSF Dose (mcg/kg) in Peripheral Blood [2]
    End point description
    The presence of myeloma tumor cells in peripheral blood was detected by flow cytometry analysis. Overall data from Day 5 pre-G-CSF administration up to Day 8 pre-G-CSF administration was calculated as: (total cumulative myeloma tumors cells count/total cumulative CD34+ cells count) divided by (cumulative G-CSF dose since Day 1/Body weight in kg), where G-CSF cumulative dose was the sum of all doses of G-CSF from the 1st administration to the last dose received prior the peripheral blood sample analyzed. The value of the body weight was the last available value before the start of first planned G-CSF. Analysis was performed on ITT population.
    End point type
    Primary
    End point timeframe
    Day 5 up to Day 8
    Notes
    [2] - 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
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: percentage of cells per mcg/kg
        arithmetic mean (standard deviation)
    0 ± 0
    0 ± 0
    No statistical analyses for this end point

    Primary: Percentage of Myeloma Tumor Cells/CD34+ Cells Count per Cumulative Plerixafor Dose (mcg/kg) in Peripheral Blood

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    End point title
    Percentage of Myeloma Tumor Cells/CD34+ Cells Count per Cumulative Plerixafor Dose (mcg/kg) in Peripheral Blood [3] [4]
    End point description
    The presence of myeloma tumor cells in peripheral blood was detected by flow cytometry analysis. Overall data from Day 5 pre-G-CSF administration up to Day 8 pre-G-CSF administration was calculated as: (total cumulative myeloma tumors cells count/total cumulative CD34+ cells count) divided by (cumulative Plerixafor dose since Day 4/Body weight in kg), where plerixafor cumulative dose was the sum of all doses of plerixafor from the 1st administration of plerixafor (Day 4) to the last dose of plerixafor received prior the peripheral blood sample analyzed. The value of the body weight was the last available value before the start of first planned G-CSF. Analysis was performed on ITT population.
    End point type
    Primary
    End point timeframe
    Day 5 up to Day 8
    Notes
    [3] - 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.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting results only for the arm in which Plerixafor was administered.
    End point values
    G-CSF + Plerixafor
    Number of subjects analysed
    10
    Units: percentage of cells per mcg/kg
        arithmetic mean (standard deviation)
    0 ± 0
    No statistical analyses for this end point

    Primary: Change from Day 4 in Tumor Cell Mobilization (TCM) in Peripheral Blood at Day 5

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    End point title
    Change from Day 4 in Tumor Cell Mobilization (TCM) in Peripheral Blood at Day 5 [5]
    End point description
    The Change in TCM was calculated as: TCM value at Day 5 (pre-G-CSF administration) minus TCM value at Day 4 (pre-G-CSF administration). Analysis was performed on ITT population. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 4, Day 5
    Notes
    [5] - 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
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    9
    8
    Units: cells/mcgL
        arithmetic mean (standard deviation)
    0 ± 0
    0 ± 0
    No statistical analyses for this end point

    Primary: Number of Myeloma Tumor Cells (*10^5 Cells/Kg) in the Apheresis Product

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    End point title
    Number of Myeloma Tumor Cells (*10^5 Cells/Kg) in the Apheresis Product [6]
    End point description
    The overall number of myeloma tumor cells was calculated as: sum of total myeloma tumor cells in apheresis product from Day 5 up to Day 8. Analysis was performed on ITT population.
    End point type
    Primary
    End point timeframe
    Day 5 up to Day 8
    Notes
    [6] - 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
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: cells (*10^5 cells/Kg)
        arithmetic mean (standard deviation)
    1.32 ± 3.42
    0.62 ± 1.33
    No statistical analyses for this end point

    Primary: Percentage of Subjects Mobilizing At least 4.5*10^5 Myeloma Tumor cells/kg Body Weight in Apheresis Product

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    End point title
    Percentage of Subjects Mobilizing At least 4.5*10^5 Myeloma Tumor cells/kg Body Weight in Apheresis Product [7]
    End point description
    The percentage of subjects mobilizing at least 4.5*10^5 myeloma tumor cells/kg body weight in the apheresis product from Day 5 up to Day 8 were reported. Overall data was calculated as subjects with the sum of total myeloma tumor cells with >=4.5*10^5 myeloma tumor cells/kg in apheresis product from Day 5 up to Day 8. Analysis was performed on ITT population.
    End point type
    Primary
    End point timeframe
    Day 5 up to Day 8
    Notes
    [7] - 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
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: percentage of subjects
        number (not applicable)
    10
    0
    No statistical analyses for this end point

    Secondary: Total CD34+ (*10^6 cells/kg) Stem Cell Yield

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    End point title
    Total CD34+ (*10^6 cells/kg) Stem Cell Yield
    End point description
    Total CD34+ (*10^6 cells/kg) stem cell yield from apheresis 1 up to apheresis 4 (up to Day 8) were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Day 5 up to Day 8
    End point values
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: cells (*10^6 cells/kg)
        arithmetic mean (standard deviation)
    6.81 ± 2.92
    8.5 ± 3.26
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reaching the Minimal Target of >=2*10^6 CD34+ cells/kg

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    End point title
    Percentage of Subjects Reaching the Minimal Target of >=2*10^6 CD34+ cells/kg
    End point description
    Percentage of subjects reaching the minimal target of >=2*10^6 CD34+ cells/kg from Day 5 up to Day 8 were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Day 5 up to Day 8
    End point values
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: percentage of subjects
        number (not applicable)
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reaching the Optimal Target of >=6*10^6 CD34+ cells/kg

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    End point title
    Percentage of Subjects Reaching the Optimal Target of >=6*10^6 CD34+ cells/kg
    End point description
    Percentage of subjects reaching the optimal target of >=6*10^6 CD34+ cells/kg from Day 5 up to Day 8 were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Day 5 up to Day 8
    End point values
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: percentage of subjects
        number (not applicable)
    40
    70
    No statistical analyses for this end point

    Secondary: Percentage of Subjects That Proceeded to Transplantations

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    End point title
    Percentage of Subjects That Proceeded to Transplantations
    End point description
    Transplantation of the collected apheresis product was performed within 2 months of last apheresis according to the standard procedures at the site. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Up to two months after last apheresis (last apheresis = up to Day 8)
    End point values
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: percentage of subjects
        number (not applicable)
    90
    90
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    Overall survival
    End point description
    Overall survival was defined as the time interval between the date of randomization and the date of death from any cause. In the absence of death before the cut-off date for the final analysis, overall survival time was censored at the earlier between the last date subject was known to be alive and the cut-off date. Estimation was performed by Kaplan-Meier method. Analysis was performed on ITT population. 99999 represented that data was not estimable due to the low number of subjects who died.
    End point type
    Secondary
    End point timeframe
    Baseline until death or study cut-off (up to 2 years follow up)
    End point values
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: months
        median (full range (min-max))
    99999 (20.44 to 99999)
    24.4 (24.38 to 99999)
    No statistical analyses for this end point

    Secondary: Best Overall Response (BOR)

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    End point title
    Best Overall Response (BOR)
    End point description
    BOR was assessed using International Myeloma Working Group Uniform Response Criteria. Complete Response(CR):Negative immunofixation on serum & urine & disappearance of any soft tissue plasmacytomas & <5% plasma cells in bone marrow.Stringent CR(sCR):CR + normal free light chain(FLC)ratio & absence of clonal cells in bone marrow by immunohistochemistry/immunofluorescence.Very good partial response(VGPR):Serum & urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-component + urine M-component level <100 mg/24 hr.Partial Response(PR):>=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by >=90% or to <200 mg/24Hr.Stable disease: Not meeting criteria for CR,VGPR,PR/Progressive Disease (PD).PD:Increase of >25% from lowest response value in any one or more of the following: •Serum M-component and/or (absolute increase must be >=0.5 g/dL)•Urine M-component and/or(absolute increase must be >=200mg/24 hr).ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization until disease progression (DP) or the end of the 2 years follow-up
    End point values
    G-CSF Alone G-CSF + Plerixafor
    Number of subjects analysed
    10
    10
    Units: percentage of subjects
    number (not applicable)
        Complete response (CR)
    0
    20
        Stringent CR (sCR)
    0
    10
        Very Good Partial Response (VGPR)
    60
    40
        Partial Response (PR)
    20
    20
        Stable Disease
    0
    0
        Progressive Disease
    10
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (up to follow up visit of 2 year) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (any AEs occurring from the first G-CSF administration up to end of the 2-year follow-up period).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    G-CSF Alone
    Reporting group description
    G-CSF (non-pegylated only) 10 mcg/kg once daily (qd) in the morning for 5 consecutive days. Morning doses of G-CSF was followed by apheresis and continued for up to a maximum of 4 apheresis or until >=6*10^6 CD34+ cells/kg were collected.

    Reporting group title
    G-CSF + Plerixafor
    Reporting group description
    G-CSF (non-pegylated only) 10 mcg/kg/day qd in the morning for 4 consecutive days, Plerixafor 240 mcg/kg in the evening of Day 4, and G-CSF (non-pegylated only) 10 mcg/kg in the morning on Day 5. Evening doses of plerixafor and morning doses of G-CSF was followed by apheresis and continued for up to a maximum of 4 apheresis or until >=6*10^6 CD34+ cells/kg were collected.

    Serious adverse events
    G-CSF Alone G-CSF + Plerixafor
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pleural Effusion
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    G-CSF Alone G-CSF + Plerixafor
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    6 / 10 (60.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Back Pain
         subjects affected / exposed
    3 / 10 (30.00%)
    3 / 10 (30.00%)
         occurrences all number
    3
    3
    Bone Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Musculoskeletal Chest Pain
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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