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    Clinical Trial Results:
    Extension of the CBYM338B2203 Phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis

    Summary
    EudraCT number
    2015-001411-12
    Trial protocol
    FR   NL   DK   GB   BE   IT  
    Global end of trial date
    13 Feb 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Feb 2018
    First version publication date
    28 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CBYM338B2203E1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02573467
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    13 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of intravenously administered bimagrumab in the treatment of sIBM as assessed by vital signs, electrocardiogram (ECG), clinical laboratory variables, and adverse events (AEs) monitoring. In addition, to further evaluate the effect of three bimagrumab dose regimens against placebo in increasing the distance traveled as measured by the 6-minute walking distance test (6MWD).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Nov 2015
    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
    Switzerland: 1
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    United States: 77
    Country: Number of subjects enrolled
    Australia: 37
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Denmark: 12
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Japan: 15
    Country: Number of subjects enrolled
    Netherlands: 18
    Worldwide total number of subjects
    211
    EEA total number of subjects
    81
    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)
    53
    From 65 to 84 years
    156
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    Participants entered extension study treatment period after completing the core study and continued on the study drug to which they were randomized in the core study (one of 3 bimagrumab doses (1mg/kg, 3mg/kg or 10mg/kg) or placebo). Participants discontinued from the treatment period were to enter a 6-month, treatment-free Follow-up Period (FUP).

    Pre-assignment
    Screening details
    All participants (N=211) were discontinued from the double-blind treatment period, 178 of whom entered the FUP. Overall 154 participants completed the FUP and 20 discontinued due to subject/guardian decision and 1 for technical reasons. Three discontinued FUP due to death (one each in the 10mg/kg, 3mg/kg, and placebo groups).

    Period 1
    Period 1 title
    Double-blind treatment epoch (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BYM338/bimagrumab 10 mg/kg
    Arm description
    Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimagrumab
    Investigational medicinal product code
    BYM338
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks.

    Arm title
    BYM338/bimagrumab 3 mg/kg
    Arm description
    Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimagrumab
    Investigational medicinal product code
    BYM338
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks.

    Arm title
    BYM338/bimagrumab 1 mg/kg
    Arm description
    Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimagrumab
    Investigational medicinal product code
    BYM338
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks.

    Arm title
    Placebo
    Arm description
    Participants received placebo administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo administered via intravenous infusion every 4 weeks.

    Number of subjects in period 1
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Started
    53
    52
    51
    55
    Full analysis set
    53
    52
    51
    55
    Completed
    0
    0
    0
    0
    Not completed
    53
    52
    51
    55
         Study Terminated by sponsor
    50
    51
    48
    55
         Adverse event, non-fatal
    1
    -
    1
    -
         Withdrawal by subject
    2
    1
    1
    -
         Lack of efficacy
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BYM338/bimagrumab 10 mg/kg
    Reporting group description
    Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.

    Reporting group title
    BYM338/bimagrumab 3 mg/kg
    Reporting group description
    Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.

    Reporting group title
    BYM338/bimagrumab 1 mg/kg
    Reporting group description
    Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.

    Reporting group values
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo Total
    Number of subjects
    53 52 51 55 211
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    11 19 11 12 53
        From 65-84 years
    42 32 39 43 156
        85 years and over
    0 1 1 0 2
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    69.2 ( 8.19 ) 67.3 ( 9.04 ) 70.0 ( 7.69 ) 69.9 ( 7.95 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    18 19 17 19 73
        Male
    35 33 34 36 138

    End points

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    End points reporting groups
    Reporting group title
    BYM338/bimagrumab 10 mg/kg
    Reporting group description
    Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.

    Reporting group title
    BYM338/bimagrumab 3 mg/kg
    Reporting group description
    Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.

    Reporting group title
    BYM338/bimagrumab 1 mg/kg
    Reporting group description
    Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.

    Primary: Number of participants with adverse events (AEs), serious adverse events (SAEs) and deaths.

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    End point title
    Number of participants with adverse events (AEs), serious adverse events (SAEs) and deaths. [1]
    End point description
    Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.
    End point type
    Primary
    End point timeframe
    to end of study (up to 14 months, including the 6-month treatment-free follow-up period)
    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: Statistical analysis does not apply to this end point.
    End point values
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    53
    52
    51
    55
    Units: Participants
        Adverse events|
    48
    50
    44
    49
        Serious adverse events|
    12
    10
    7
    8
        Deaths|
    1
    1
    1
    2
    No statistical analyses for this end point

    Primary: Change from core study baseline in 6 Minute Walking Distance Test (6MWD)

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    End point title
    Change from core study baseline in 6 Minute Walking Distance Test (6MWD) [2]
    End point description
    The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
    End point type
    Primary
    End point timeframe
    Core study baseline, weeks 52, 78, 104
    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: Descriptive statistics only were calculated for this end point.
    End point values
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    53
    52
    51
    55
    Units: meters
    arithmetic mean (standard deviation)
        Week 52 (n=53,52,51,54)|
    6.88 ( 68.948 )
    9.48 ( 81.676 )
    -14.26 ( 81.029 )
    -5.98 ( 78.817 )
        Week 78 (n=52,52,50,54)|
    -5.25 ( 122.002 )
    -9.73 ( 68.302 )
    -18.66 ( 81.536 )
    -32.78 ( 96.494 )
        Week 104 (n=32,34,37,39)|
    -22.68 ( 102.549 )
    -50.58 ( 118.012 )
    -25.08 ( 95.737 )
    -61.30 ( 107.399 )
    No statistical analyses for this end point

    Secondary: Change from core study baseline in quadriceps Quantitative Muscle Testing (QMT) on the right side

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    End point title
    Change from core study baseline in quadriceps Quantitative Muscle Testing (QMT) on the right side
    End point description
    Quantitative Muscle Testing (QMT) was used to describe the long-term evolution of quadriceps muscle strength on the right side. The QMT was performed using the same portable fixed dynamometry (PFD) used in the core study. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
    End point type
    Secondary
    End point timeframe
    Core study baseline, week 52, week 78, week 104
    End point values
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    53
    52
    51
    55
    Units: newtons
    arithmetic mean (standard deviation)
        Week 52 (n=48,49,51,55)|
    -6.29 ( 31.121 )
    -19.70 ( 77.820 )
    -5.62 ( 32.245 )
    -14.22 ( 27.577 )
        Week 78 (n=46,49,49,53)|
    -9.43 ( 41.285 )
    -23.76 ( 73.729 )
    -17.04 ( 25.696 )
    -21.02 ( 31.391 )
        Week 104 (n=33,33,37,37)|
    -11.92 ( 35.243 )
    -16.99 ( 34.379 )
    -18.63 ( 37.968 )
    -21.91 ( 39.985 )
    No statistical analyses for this end point

    Secondary: Change from core study baseline in sporadic inclusion body myositis (sIBM) functional assessment (sIFA) score

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    End point title
    Change from core study baseline in sporadic inclusion body myositis (sIBM) functional assessment (sIFA) score
    End point description
    Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
    End point type
    Secondary
    End point timeframe
    Core study baseline, week 52, week 78, week 104
    End point values
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    53
    52
    51
    55
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 52 (n=53,52,49,52)|
    -1.34 ( 15.249 )
    1.80 ( 11.910 )
    3.17 ( 11.380 )
    5.16 ( 13.889 )
        Week 78 (n=53,51,48,54)|
    -0.27 ( 13.745 )
    5.33 ( 13.099 )
    6.52 ( 12.918 )
    7.41 ( 14.410 )
        Week 104 (n=38,37,35,40)|
    3.54 ( 14.998 )
    8.04 ( 16.861 )
    5.97 ( 12.849 )
    7.39 ( 15.580 )
    No statistical analyses for this end point

    Secondary: Estimated annual number of falls per participant within treatment group

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    End point title
    Estimated annual number of falls per participant within treatment group
    End point description
    Participants documented any fall occurrences in a paper diary during the study.
    End point type
    Secondary
    End point timeframe
    Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)
    End point values
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    53
    52
    51
    55
    Units: Annual number of falls per participant
        number (not applicable)
    4.164
    3.879
    3.480
    3.835
    No statistical analyses for this end point

    Secondary: Change from core study baseline in Short Physical Performance Battery (SPPB) score

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    End point title
    Change from core study baseline in Short Physical Performance Battery (SPPB) score
    End point description
    The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
    End point type
    Secondary
    End point timeframe
    Core study baseline, week 52, week 78, week 104
    End point values
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    53
    52
    51
    55
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 52 (n=53,52,51,55)|
    0.3 ( 1.73 )
    0.2 ( 1.61 )
    -0.4 ( 1.74 )
    -0.3 ( 1.31 )
        Week 78 (n=53,52,50,55)|
    -0.5 ( 2.58 )
    -0.1 ( 1.54 )
    -0.4 ( 1.69 )
    -0.9 ( 1.92 )
        Week 104 (n=38,38,39,41)|
    -1.4 ( 3.29 )
    -0.9 ( 2.77 )
    -1.1 ( 2.56 )
    -1.3 ( 2.35 )
    No statistical analyses for this end point

    Secondary: Change in muscles of the thigh

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    End point title
    Change in muscles of the thigh
    End point description
    Magnetic resonance imaging (MRI) was planned to be used to characterize changes in muscles of the thigh in a subset of patients.
    End point type
    Secondary
    End point timeframe
    up to 1 year, up to 2 years
    End point values
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    Units: Percentage
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [3] - No participants were analyzed; optional MRI assessment was not initiated as the study was stopped.
    [4] - No participants were analyzed; optional MRI assessment was not initiated as the study was stopped.
    [5] - No participants were analyzed; optional MRI assessment was not initiated as the study was stopped.
    [6] - No participants were analyzed; optional MRI assessment was not initiated as the study was stopped.
    No statistical analyses for this end point

    Secondary: Number of patients with anti-BYM338 antibodies

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    End point title
    Number of patients with anti-BYM338 antibodies
    End point description
    Investigated the development of immunogenicity against BYM338.
    End point type
    Secondary
    End point timeframe
    end of double-blind treatment (up to 8 months)
    End point values
    BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    38
    40
    38
    39
    Units: Participants
    0
    1
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    BYM338 10 mg/kg
    Reporting group description
    BYM338 10 mg/kg

    Reporting group title
    BYM338 3 mg/kg
    Reporting group description
    BYM338 3 mg/kg

    Reporting group title
    BYM338 1 mg/kg
    Reporting group description
    BYM338 1 mg/kg

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Reporting group title
    Pooled active treatment groups
    Reporting group description
    Pooled active treatment groups

    Serious adverse events
    BYM338 10 mg/kg BYM338 3 mg/kg BYM338 1 mg/kg Placebo Pooled active treatment groups
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 53 (22.64%)
    10 / 52 (19.23%)
    7 / 51 (13.73%)
    8 / 55 (14.55%)
    29 / 156 (18.59%)
         number of deaths (all causes)
    1
    1
    1
    2
    3
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    2 / 55 (3.64%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    2 / 156 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    2 / 156 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Avulsion fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 55 (1.82%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    1 / 55 (1.82%)
    3 / 156 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inclusion body myositis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    1 / 55 (1.82%)
    3 / 156 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    Sepsis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    2 / 55 (3.64%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    BYM338 10 mg/kg BYM338 3 mg/kg BYM338 1 mg/kg Placebo Pooled active treatment groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 53 (75.47%)
    46 / 52 (88.46%)
    38 / 51 (74.51%)
    43 / 55 (78.18%)
    124 / 156 (79.49%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    9 / 53 (16.98%)
    7 / 52 (13.46%)
    12 / 51 (23.53%)
    8 / 55 (14.55%)
    28 / 156 (17.95%)
         occurrences all number
    10
    9
    15
    13
    34
    Fall
         subjects affected / exposed
    30 / 53 (56.60%)
    36 / 52 (69.23%)
    30 / 51 (58.82%)
    34 / 55 (61.82%)
    96 / 156 (61.54%)
         occurrences all number
    117
    94
    73
    88
    284
    Foot fracture
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    4 / 55 (7.27%)
    4 / 156 (2.56%)
         occurrences all number
    3
    1
    0
    4
    4
    Injury
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    4 / 156 (2.56%)
         occurrences all number
    15
    1
    0
    1
    16
    Joint injury
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    3 / 156 (1.92%)
         occurrences all number
    4
    0
    0
    0
    4
    Laceration
         subjects affected / exposed
    1 / 53 (1.89%)
    7 / 52 (13.46%)
    4 / 51 (7.84%)
    6 / 55 (10.91%)
    12 / 156 (7.69%)
         occurrences all number
    1
    9
    5
    8
    15
    Ligament sprain
         subjects affected / exposed
    5 / 53 (9.43%)
    2 / 52 (3.85%)
    2 / 51 (3.92%)
    3 / 55 (5.45%)
    9 / 156 (5.77%)
         occurrences all number
    5
    2
    2
    4
    9
    Limb injury
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
    5 / 156 (3.21%)
         occurrences all number
    3
    1
    1
    0
    5
    Skin abrasion
         subjects affected / exposed
    6 / 53 (11.32%)
    7 / 52 (13.46%)
    4 / 51 (7.84%)
    5 / 55 (9.09%)
    17 / 156 (10.90%)
         occurrences all number
    10
    9
    6
    7
    25
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    4 / 55 (7.27%)
    4 / 156 (2.56%)
         occurrences all number
    2
    0
    2
    5
    4
    Hypertension
         subjects affected / exposed
    5 / 53 (9.43%)
    2 / 52 (3.85%)
    2 / 51 (3.92%)
    1 / 55 (1.82%)
    9 / 156 (5.77%)
         occurrences all number
    5
    2
    2
    1
    9
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    3 / 55 (5.45%)
    1 / 156 (0.64%)
         occurrences all number
    1
    0
    0
    3
    1
    Headache
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 52 (3.85%)
    4 / 51 (7.84%)
    3 / 55 (5.45%)
    7 / 156 (4.49%)
         occurrences all number
    1
    2
    5
    4
    8
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    3 / 51 (5.88%)
    1 / 55 (1.82%)
    3 / 156 (1.92%)
         occurrences all number
    0
    0
    3
    1
    3
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 52 (7.69%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
    4 / 156 (2.56%)
         occurrences all number
    0
    5
    0
    0
    5
    Diarrhoea
         subjects affected / exposed
    9 / 53 (16.98%)
    5 / 52 (9.62%)
    9 / 51 (17.65%)
    5 / 55 (9.09%)
    23 / 156 (14.74%)
         occurrences all number
    10
    8
    9
    9
    27
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    3 / 55 (5.45%)
    2 / 156 (1.28%)
         occurrences all number
    0
    2
    1
    3
    3
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    1 / 55 (1.82%)
    6 / 156 (3.85%)
         occurrences all number
    2
    2
    5
    1
    9
    Pruritus
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    3 / 55 (5.45%)
    5 / 156 (3.21%)
         occurrences all number
    3
    0
    2
    3
    5
    Rash
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 52 (5.77%)
    3 / 51 (5.88%)
    1 / 55 (1.82%)
    8 / 156 (5.13%)
         occurrences all number
    2
    5
    3
    1
    10
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 53 (1.89%)
    5 / 52 (9.62%)
    6 / 51 (11.76%)
    6 / 55 (10.91%)
    12 / 156 (7.69%)
         occurrences all number
    1
    6
    6
    6
    13
    Back pain
         subjects affected / exposed
    2 / 53 (3.77%)
    4 / 52 (7.69%)
    3 / 51 (5.88%)
    1 / 55 (1.82%)
    9 / 156 (5.77%)
         occurrences all number
    2
    4
    3
    1
    9
    Muscle spasms
         subjects affected / exposed
    4 / 53 (7.55%)
    8 / 52 (15.38%)
    3 / 51 (5.88%)
    1 / 55 (1.82%)
    15 / 156 (9.62%)
         occurrences all number
    5
    9
    3
    1
    17
    Muscular weakness
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 52 (5.77%)
    0 / 51 (0.00%)
    3 / 55 (5.45%)
    4 / 156 (2.56%)
         occurrences all number
    1
    4
    0
    4
    5
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 52 (3.85%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
    5 / 156 (3.21%)
         occurrences all number
    3
    2
    0
    1
    5
    Musculoskeletal pain
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 52 (3.85%)
    4 / 51 (7.84%)
    2 / 55 (3.64%)
    8 / 156 (5.13%)
         occurrences all number
    2
    2
    4
    2
    8
    Myalgia
         subjects affected / exposed
    2 / 53 (3.77%)
    4 / 52 (7.69%)
    2 / 51 (3.92%)
    0 / 55 (0.00%)
    8 / 156 (5.13%)
         occurrences all number
    2
    4
    2
    0
    8
    Neck pain
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    5 / 55 (9.09%)
    0 / 156 (0.00%)
         occurrences all number
    0
    0
    0
    5
    0
    Pain in extremity
         subjects affected / exposed
    1 / 53 (1.89%)
    5 / 52 (9.62%)
    3 / 51 (5.88%)
    2 / 55 (3.64%)
    9 / 156 (5.77%)
         occurrences all number
    1
    7
    5
    2
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 52 (7.69%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
    5 / 156 (3.21%)
         occurrences all number
    0
    5
    1
    0
    6
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 53 (5.66%)
    3 / 52 (5.77%)
    4 / 51 (7.84%)
    4 / 55 (7.27%)
    10 / 156 (6.41%)
         occurrences all number
    5
    4
    4
    4
    13

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Oct 2015
    Amendment 1 was released before any patients were enrolled. Subsequent to comments received from several Health Authorities, the following changes were made to the protocol and were applicable to the countries as indicated in the amendment: • The protocol was modified to remove reference to patients continuing in the study until commercial availability of bimagrumab, and the duration of Treatment Period 2 was specified as one year. The duration of Treatment Period 2 was to be extended beyond one year in the future if required via a protocol amendment. • The protocol was also amended to clarify that this extension study would be terminated if the outcome of the core study (CBYM338B2203) was negative, i.e., none of the doses of bimagrumab were found to be effective. In the event more than one dose evaluated in the core study was found to be effective, additional data (i.e., from Treatment Period 1 or from other studies of bimagrumab) was to be considered in order to support selection of the dose for Treatment Period 2. • The original protocol described that the study could be terminated by the Sponsor at any time and for any reason. In response to Health Authority feedback, it was proposed to include additional text to account for the possibility that the trial was to be terminated as per protocol in case the benefit/risk of bimagrumab becomes negative or if the DMC made a recommendation to stop this extension study.

    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.
    The core study has been completed but since the core study did not meet the primary end point, the extension study was terminated as per protocol.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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