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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, Phase 2b/3 study to evaluate the efficacy, safety, and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis

    Summary
    EudraCT number
    		 2013-000705-23
    Trial protocol
    		 IT   NL   DE   BE   GB   DK  
    Global end of trial date
    06 Jan 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    31 May 2017
    First version publication date
    21 Jan 2017
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    Title updated and new data added to secondary end point (EP) #2 (LBM); description updated for secondary EP #4 (sIFA); and title and unit updated in EP#5 (Falls).

    Trial information

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    Trial identification
    Sponsor protocol code
    CBYM338B2203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01925209
    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
    06 Jan 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate that at least one dose regimen of bimagrumab in ambulatory sporadic inclusion body myositis (sIBM) patients increased the distance traveled, as measured by change from baseline at Week 52 of the 6MWD test relative to placebo.
    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
    26 Sep 2013
    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
    Australia: 42
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Denmark: 14
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    United Kingdom: 29
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Japan: 20
    Country: Number of subjects enrolled
    Netherlands: 18
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    United States: 94
    Worldwide total number of subjects
    251
    EEA total number of subjects
    94
    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)
    75
    From 65 to 84 years
    175
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were randomized into one of the four treatment arms in a 1:1:1:1 ratio.

    Pre-assignment
    Screening details
    		 The study included 4 epochs: screening (up to 28 days pre-treatment), treatment (from day 1 up to 52 weeks), treatment maintenance (from week 52 up to 104 weeks) and follow-up (28 days after last dose administration). The disposition data reported are for the treatment epoch.

    Period 1
    Period 1 title
    Treatment Epoch (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BYM338/bimagrumab 10 mg/kg
    Arm description
    		 Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
    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 at 10 mg/kg intravenous (i.v.) infusion every 4 weeks from Day 1 to Week 52, and up to Week 104.

    Arm title
    		 BYM338/bimagrumab 3 mg/kg
    Arm description
    		 Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
    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 at 3 mg/kg i.v. infusion every 4 weeks from Day 1 to Week 52, and up to Week 104.

    Arm title
    		 BYM338/bimagrumab 1 mg/kg
    Arm description
    		 Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
    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 at 1 mg/kg i.v. infusion every 4 weeks from Day 1 to Week 52, and up to Week 104.

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
    Arm type
    		 Placebo

    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 matching placebo to BYM338 i.v. infusion every 4 weeks from Day 1 to Week 52, and up to Week 104.

    Number of subjects in period 1
    		BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Started
    63
    63
    63
    62
    Full Analysis Set
    63
    63
    63
    62
    Completed
    54
    55
    56
    57
    Not completed
    9
    8
    7
    5
         Adverse event, serious fatal
    1
    -
    -
    -
         Physician decision
    1
    -
    -
    -
         Adverse event, non-fatal
    3
    5
    3
    1
         Protocol deviation
    -
    -
    1
    1
         Non-compliance with study treatment
    -
    -
    -
    1
         Withdrawal by subject
    4
    3
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BYM338/bimagrumab 10 mg/kg
    Reporting group description
    		 Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.

    Reporting group title
    BYM338/bimagrumab 3 mg/kg
    Reporting group description
    		 Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.

    Reporting group title
    BYM338/bimagrumab 1 mg/kg
    Reporting group description
    		 Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.

    Reporting group values
    		 BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo Total
    Number of subjects
    		 63 63 63 62 251
    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)
    		 16 27 14 18 75
        From 65-84 years
    		 47 36 48 44 175
        85 years and over
    		 0 0 1 0 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 68 ± 7.93 66.5 ± 8.72 69.4 ± 7.91 68.4 ± 8.12 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 22 21 23 23 89
        Male
    		 41 42 40 39 162

    End points

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    End points reporting groups
    Reporting group title
    BYM338/bimagrumab 10 mg/kg
    Reporting group description
    		 Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.

    Reporting group title
    BYM338/bimagrumab 3 mg/kg
    Reporting group description
    		 Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.

    Reporting group title
    BYM338/bimagrumab 1 mg/kg
    Reporting group description
    		 Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.

    Primary: Change from Baseline in 6 Minute Walking Distance (6MWD) Test at week 52

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    End point title
    		 Change from Baseline in 6 Minute Walking Distance (6MWD) Test at week 52
    End point description
    The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    Baseline, Week 52
    End point values
    		 BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    61
    63
    63
    62
    Units: meters
        least squares mean (standard error)
    8.63 ± 10.934
    9.63 ± 10.77
    -10.27 ± 10.718
    -8.96 ± 10.765
    Statistical analysis title
    		 Change from Baseline in 6MWD at week 52
    Comparison groups
    BYM338/bimagrumab 10 mg/kg v Placebo
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.221
    Method
    		 mixed model repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    17.59
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 -19.63
         upper limit
    		 54.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    14.331
    Statistical analysis title
    		 Change from Baseline in 6MWD at week 52
    Comparison groups
    BYM338/bimagrumab 3 mg/kg v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1909
    Method
    		 mixed model repeated measure
    Parameter type
    		 Mean difference (net)
    Point estimate
    18.59
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 -18.21
         upper limit
    		 55.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    14.176
    Statistical analysis title
    		 Change from Baseline in 6MWD at week 52
    Comparison groups
    BYM338/bimagrumab 1 mg/kg v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9263
    Method
    		 mixed models repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.31
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 -37.97
         upper limit
    		 35.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    14.121

    Secondary: Estimated within treatment group lean body mass (LBM) ratio at week 52

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    End point title
    		 Estimated within treatment group lean body mass (LBM) ratio at week 52
    End point description
    LBM was measured via dual energy x-ray absorptiometry (DXA) and calculated as (LBM at Week 52/LBM at baseline)*100 . A positive change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    62
    61
    63
    61
    Units: Percentage
        number (confidence interval 95%)
    102.8 (101.4 to 104.2)
    100.4 (99.1 to 101.8)
    98.3 (97 to 99.6)
    97.2 (95.9 to 98.5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in quadriceps Quantitative Muscle Testing (QMT) on the right side at week 52

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    End point title
    		 Change from Baseline in quadriceps Quantitative Muscle Testing (QMT) on the right side at week 52
    End point description
    Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    60
    63
    63
    61
    Units: newtons
        least squares mean (standard error)
    -12.44 ± 6.021
    -20.36 ± 5.843
    -14.89 ± 5.828
    -16.48 ± 5.83
    No statistical analyses for this end point

    Secondary: Change from baseline in sIBM functional assessment (sIFA) at week 52

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    End point title
    		 Change from baseline in sIBM functional assessment (sIFA) at week 52
    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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    61
    63
    60
    61
    Units: score on a scale
        least squares mean (standard error)
    1.74 ± 1.915
    3.56 ± 1.876
    6.12 ± 1.899
    6.85 ± 1.895
    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
    Week 52
    End point values
    		 BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    63
    63
    63
    62
    Units: Annual number of falls per participant
        number (not applicable)
    4.33
    4.02
    4.7
    5.13
    No statistical analyses for this end point

    Secondary: Change from Baseline in Short Physical Performance Battery (SPPB) score at week 52

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    End point title
    		 Change from Baseline in Short Physical Performance Battery (SPPB) score at week 52
    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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 BYM338/bimagrumab 10 mg/kg BYM338/bimagrumab 3 mg/kg BYM338/bimagrumab 1 mg/kg Placebo
    Number of subjects analysed
    62
    63
    63
    62
    Units: score on a scale
        least squares mean (standard error)
    0 ± 0.24
    0 ± 0.23
    -0.5 ± 0.23
    -0.5 ± 0.23
    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
    18.1
    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

    Serious adverse events
    		 BYM338 10 mg/kg BYM338 3 mg/kg BYM338 1 mg/kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 63 (33.33%)
    11 / 63 (17.46%)
    18 / 63 (28.57%)
    20 / 62 (32.26%)
         number of deaths (all causes)
    1
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BASAL CELL CARCINOMA
         subjects affected / exposed
    3 / 63 (4.76%)
    3 / 63 (4.76%)
    1 / 63 (1.59%)
    3 / 62 (4.84%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LUNG ADENOCARCINOMA
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    SQUAMOUS CELL CARCINOMA
         subjects affected / exposed
    2 / 63 (3.17%)
    2 / 63 (3.17%)
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SQUAMOUS CELL CARCINOMA OF SKIN
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    AORTIC ANEURYSM
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PERIPHERAL ISCHAEMIA
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    INJURY ASSOCIATED WITH DEVICE
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASPIRATION
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA ASPIRATION
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    DEPRESSION
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SUICIDE ATTEMPT
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ANKLE FRACTURE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CARBON MONOXIDE POISONING
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CERVICAL VERTEBRAL FRACTURE
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ENDOTRACHEAL INTUBATION COMPLICATION
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    EYE INJURY
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FACIAL BONES FRACTURE
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FALL
         subjects affected / exposed
    2 / 63 (3.17%)
    2 / 63 (3.17%)
    4 / 63 (6.35%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FEMUR FRACTURE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FIBULA FRACTURE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FOOT FRACTURE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HAND FRACTURE
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INTENTIONAL OVERDOSE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    LACERATION
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PATELLA FRACTURE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SPINAL CORD INJURY CERVICAL
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    THORACIC VERTEBRAL FRACTURE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TIBIA FRACTURE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRAUMATIC HAEMATOMA
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VASCULAR PSEUDOANEURYSM
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    WRIST FRACTURE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK SECOND DEGREE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    PALPITATIONS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CAROTID ARTERY STENOSIS
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PRESYNCOPE
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SYNCOPE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRANSIENT GLOBAL AMNESIA
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    RETINAL ARTERY OCCLUSION
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ABDOMINAL HERNIA
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    3 / 63 (4.76%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DYSPHAGIA
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VOLVULUS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RASH PRURITIC
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    BLADDER MASS
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HAEMATURIA
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    URINARY RETENTION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MYALGIA
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VERTEBRAL FORAMINAL STENOSIS
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    DIVERTICULITIS
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    STREPTOCOCCAL BACTERAEMIA
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPONATRAEMIA
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    63 / 63 (100.00%)
    63 / 63 (100.00%)
    63 / 63 (100.00%)
    61 / 62 (98.39%)
    Vascular disorders
    HAEMATOMA
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 63 (3.17%)
    7 / 63 (11.11%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    9
    3
    HYPERTENSION
         subjects affected / exposed
    7 / 63 (11.11%)
    7 / 63 (11.11%)
    5 / 63 (7.94%)
    9 / 62 (14.52%)
         occurrences all number
    7
    7
    6
    12
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 63 (4.76%)
    4 / 63 (6.35%)
    6 / 62 (9.68%)
         occurrences all number
    1
    3
    4
    6
    FATIGUE
         subjects affected / exposed
    9 / 63 (14.29%)
    4 / 63 (6.35%)
    14 / 63 (22.22%)
    7 / 62 (11.29%)
         occurrences all number
    10
    4
    28
    8
    OEDEMA PERIPHERAL
         subjects affected / exposed
    5 / 63 (7.94%)
    9 / 63 (14.29%)
    9 / 63 (14.29%)
    7 / 62 (11.29%)
         occurrences all number
    6
    11
    9
    8
    PYREXIA
         subjects affected / exposed
    3 / 63 (4.76%)
    1 / 63 (1.59%)
    3 / 63 (4.76%)
    5 / 62 (8.06%)
         occurrences all number
    3
    1
    4
    16
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    3 / 63 (4.76%)
    3 / 63 (4.76%)
    4 / 63 (6.35%)
    8 / 62 (12.90%)
         occurrences all number
    3
    3
    4
    10
    DYSPNOEA
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    4 / 62 (6.45%)
         occurrences all number
    2
    0
    1
    4
    RHINORRHOEA
         subjects affected / exposed
    4 / 63 (6.35%)
    3 / 63 (4.76%)
    5 / 63 (7.94%)
    5 / 62 (8.06%)
         occurrences all number
    4
    3
    5
    5
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 63 (3.17%)
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    4
    2
    1
    2
    DEPRESSED MOOD
         subjects affected / exposed
    4 / 63 (6.35%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    4
    2
    0
    1
    DEPRESSION
         subjects affected / exposed
    4 / 63 (6.35%)
    1 / 63 (1.59%)
    5 / 63 (7.94%)
    0 / 62 (0.00%)
         occurrences all number
    4
    1
    5
    0
    INSOMNIA
         subjects affected / exposed
    5 / 63 (7.94%)
    0 / 63 (0.00%)
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    6
    0
    2
    1
    Investigations
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    3 / 63 (4.76%)
    5 / 63 (7.94%)
    4 / 63 (6.35%)
    0 / 62 (0.00%)
         occurrences all number
    3
    5
    4
    0
    VITAMIN D DECREASED
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 63 (3.17%)
    3 / 63 (4.76%)
    1 / 62 (1.61%)
         occurrences all number
    4
    3
    3
    1
    WEIGHT DECREASED
         subjects affected / exposed
    9 / 63 (14.29%)
    4 / 63 (6.35%)
    8 / 63 (12.70%)
    3 / 62 (4.84%)
         occurrences all number
    9
    4
    8
    3
    Injury, poisoning and procedural complications
    CONTUSION
         subjects affected / exposed
    14 / 63 (22.22%)
    23 / 63 (36.51%)
    22 / 63 (34.92%)
    22 / 62 (35.48%)
         occurrences all number
    53
    34
    37
    34
    FALL
         subjects affected / exposed
    47 / 63 (74.60%)
    55 / 63 (87.30%)
    54 / 63 (85.71%)
    52 / 62 (83.87%)
         occurrences all number
    281
    286
    294
    356
    FOOT FRACTURE
         subjects affected / exposed
    3 / 63 (4.76%)
    3 / 63 (4.76%)
    4 / 63 (6.35%)
    4 / 62 (6.45%)
         occurrences all number
    3
    4
    4
    4
    HEAD INJURY
         subjects affected / exposed
    4 / 63 (6.35%)
    4 / 63 (6.35%)
    3 / 63 (4.76%)
    3 / 62 (4.84%)
         occurrences all number
    4
    4
    3
    6
    INJURY
         subjects affected / exposed
    4 / 63 (6.35%)
    0 / 63 (0.00%)
    7 / 63 (11.11%)
    3 / 62 (4.84%)
         occurrences all number
    8
    0
    9
    4
    JOINT INJURY
         subjects affected / exposed
    5 / 63 (7.94%)
    3 / 63 (4.76%)
    6 / 63 (9.52%)
    5 / 62 (8.06%)
         occurrences all number
    13
    4
    6
    5
    LACERATION
         subjects affected / exposed
    6 / 63 (9.52%)
    5 / 63 (7.94%)
    12 / 63 (19.05%)
    9 / 62 (14.52%)
         occurrences all number
    7
    5
    14
    15
    LIGAMENT SPRAIN
         subjects affected / exposed
    7 / 63 (11.11%)
    10 / 63 (15.87%)
    9 / 63 (14.29%)
    10 / 62 (16.13%)
         occurrences all number
    8
    14
    12
    14
    LIMB INJURY
         subjects affected / exposed
    5 / 63 (7.94%)
    7 / 63 (11.11%)
    2 / 63 (3.17%)
    8 / 62 (12.90%)
         occurrences all number
    6
    10
    3
    10
    SKIN ABRASION
         subjects affected / exposed
    14 / 63 (22.22%)
    14 / 63 (22.22%)
    14 / 63 (22.22%)
    17 / 62 (27.42%)
         occurrences all number
    28
    16
    23
    35
    SOFT TISSUE INJURY
         subjects affected / exposed
    3 / 63 (4.76%)
    5 / 63 (7.94%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    3
    13
    3
    3
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    6 / 63 (9.52%)
    10 / 63 (15.87%)
    6 / 63 (9.52%)
    8 / 62 (12.90%)
         occurrences all number
    7
    13
    7
    11
    DYSGEUSIA
         subjects affected / exposed
    5 / 63 (7.94%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    5
    1
    0
    1
    HEADACHE
         subjects affected / exposed
    12 / 63 (19.05%)
    4 / 63 (6.35%)
    14 / 63 (22.22%)
    9 / 62 (14.52%)
         occurrences all number
    21
    7
    23
    15
    HYPOAESTHESIA
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 63 (1.59%)
    3 / 63 (4.76%)
    5 / 62 (8.06%)
         occurrences all number
    2
    1
    3
    6
    MUSCLE CONTRACTIONS INVOLUNTARY
         subjects affected / exposed
    3 / 63 (4.76%)
    6 / 63 (9.52%)
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    3
    7
    0
    2
    PARAESTHESIA
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 63 (3.17%)
    2 / 63 (3.17%)
    5 / 62 (8.06%)
         occurrences all number
    0
    2
    2
    5
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    5 / 63 (7.94%)
    3 / 63 (4.76%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    5
    3
    0
    1
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    3 / 63 (4.76%)
    4 / 63 (6.35%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    3
    5
    0
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    2 / 63 (3.17%)
    6 / 63 (9.52%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    3
    8
    1
    0
    CONSTIPATION
         subjects affected / exposed
    6 / 63 (9.52%)
    3 / 63 (4.76%)
    6 / 63 (9.52%)
    3 / 62 (4.84%)
         occurrences all number
    6
    3
    6
    3
    DIARRHOEA
         subjects affected / exposed
    32 / 63 (50.79%)
    28 / 63 (44.44%)
    20 / 63 (31.75%)
    11 / 62 (17.74%)
         occurrences all number
    56
    65
    50
    30
    DRY MOUTH
         subjects affected / exposed
    5 / 63 (7.94%)
    1 / 63 (1.59%)
    3 / 63 (4.76%)
    4 / 62 (6.45%)
         occurrences all number
    5
    1
    4
    4
    DYSPHAGIA
         subjects affected / exposed
    5 / 63 (7.94%)
    4 / 63 (6.35%)
    1 / 63 (1.59%)
    5 / 62 (8.06%)
         occurrences all number
    6
    4
    1
    5
    NAUSEA
         subjects affected / exposed
    11 / 63 (17.46%)
    4 / 63 (6.35%)
    9 / 63 (14.29%)
    5 / 62 (8.06%)
         occurrences all number
    13
    5
    11
    5
    VOMITING
         subjects affected / exposed
    4 / 63 (6.35%)
    1 / 63 (1.59%)
    2 / 63 (3.17%)
    3 / 62 (4.84%)
         occurrences all number
    4
    1
    2
    3
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    12 / 63 (19.05%)
    19 / 63 (30.16%)
    8 / 63 (12.70%)
    6 / 62 (9.68%)
         occurrences all number
    15
    33
    10
    6
    DRY SKIN
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 63 (3.17%)
    1 / 63 (1.59%)
    5 / 62 (8.06%)
         occurrences all number
    1
    2
    1
    5
    PRURITUS
         subjects affected / exposed
    6 / 63 (9.52%)
    6 / 63 (9.52%)
    6 / 63 (9.52%)
    1 / 62 (1.61%)
         occurrences all number
    7
    6
    6
    1
    RASH
         subjects affected / exposed
    13 / 63 (20.63%)
    8 / 63 (12.70%)
    9 / 63 (14.29%)
    8 / 62 (12.90%)
         occurrences all number
    17
    15
    10
    10
    ROSACEA
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 63 (6.35%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    7
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    15 / 63 (23.81%)
    14 / 63 (22.22%)
    19 / 63 (30.16%)
    15 / 62 (24.19%)
         occurrences all number
    20
    24
    36
    29
    BACK PAIN
         subjects affected / exposed
    10 / 63 (15.87%)
    8 / 63 (12.70%)
    14 / 63 (22.22%)
    9 / 62 (14.52%)
         occurrences all number
    10
    8
    17
    13
    JOINT SWELLING
         subjects affected / exposed
    5 / 63 (7.94%)
    4 / 63 (6.35%)
    1 / 63 (1.59%)
    6 / 62 (9.68%)
         occurrences all number
    6
    4
    2
    6
    MUSCLE SPASMS
         subjects affected / exposed
    32 / 63 (50.79%)
    43 / 63 (68.25%)
    25 / 63 (39.68%)
    13 / 62 (20.97%)
         occurrences all number
    54
    69
    33
    17
    MUSCLE TWITCHING
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 63 (6.35%)
    2 / 63 (3.17%)
    4 / 62 (6.45%)
         occurrences all number
    3
    6
    2
    6
    MUSCULAR WEAKNESS
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 63 (6.35%)
    3 / 63 (4.76%)
    3 / 62 (4.84%)
         occurrences all number
    2
    4
    3
    3
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    5 / 63 (7.94%)
    4 / 63 (6.35%)
    7 / 63 (11.11%)
    4 / 62 (6.45%)
         occurrences all number
    5
    5
    10
    4
    MUSCULOSKELETAL STIFFNESS
         subjects affected / exposed
    4 / 63 (6.35%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    5
    0
    1
    2
    MYALGIA
         subjects affected / exposed
    5 / 63 (7.94%)
    11 / 63 (17.46%)
    7 / 63 (11.11%)
    8 / 62 (12.90%)
         occurrences all number
    5
    13
    10
    12
    PAIN IN EXTREMITY
         subjects affected / exposed
    5 / 63 (7.94%)
    4 / 63 (6.35%)
    13 / 63 (20.63%)
    7 / 62 (11.29%)
         occurrences all number
    5
    5
    26
    9
    Infections and infestations
    FOLLICULITIS
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 63 (3.17%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    4
    2
    0
    1
    INFLUENZA
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 63 (6.35%)
    4 / 63 (6.35%)
    2 / 62 (3.23%)
         occurrences all number
    3
    5
    4
    2
    NASOPHARYNGITIS
         subjects affected / exposed
    6 / 63 (9.52%)
    11 / 63 (17.46%)
    9 / 63 (14.29%)
    6 / 62 (9.68%)
         occurrences all number
    8
    11
    13
    6
    RHINITIS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    1 / 63 (1.59%)
    4 / 62 (6.45%)
         occurrences all number
    0
    2
    1
    5
    SINUSITIS
         subjects affected / exposed
    1 / 63 (1.59%)
    4 / 63 (6.35%)
    1 / 63 (1.59%)
    4 / 62 (6.45%)
         occurrences all number
    3
    4
    1
    6
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    11 / 63 (17.46%)
    11 / 63 (17.46%)
    14 / 63 (22.22%)
    10 / 62 (16.13%)
         occurrences all number
    13
    14
    19
    16
    URINARY TRACT INFECTION
         subjects affected / exposed
    4 / 63 (6.35%)
    4 / 63 (6.35%)
    2 / 63 (3.17%)
    4 / 62 (6.45%)
         occurrences all number
    4
    7
    4
    4
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    10 / 63 (15.87%)
    3 / 63 (4.76%)
    3 / 63 (4.76%)
    1 / 62 (1.61%)
         occurrences all number
    10
    3
    3
    1
    GOUT
         subjects affected / exposed
    3 / 63 (4.76%)
    0 / 63 (0.00%)
    4 / 63 (6.35%)
    2 / 62 (3.23%)
         occurrences all number
    3
    0
    6
    5
    HYPERCHOLESTEROLAEMIA
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 63 (6.35%)
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    2
    4
    2
    1
    HYPOMAGNESAEMIA
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 63 (3.17%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    4
    2
    0
    0
    VITAMIN D DEFICIENCY
         subjects affected / exposed
    6 / 63 (9.52%)
    12 / 63 (19.05%)
    3 / 63 (4.76%)
    11 / 62 (17.74%)
         occurrences all number
    7
    13
    3
    12

    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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    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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