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    Clinical Trial Results:
    A 28 week, randomized, double-blind, placebo-controlled, two-part, multi-center,parallel group dose range finding study to assess the effect of monthly doses of bimagrumab 70, 210, and 700 mg on skeletal muscle strength and function in older adults with sarcopenia (InvestiGAIT)

    Summary
    EudraCT number
    		 2014-003482-25
    Trial protocol
    		 ES   DK   BE   CZ  
    Global end of trial date
    28 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2019
    First version publication date
    30 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CBYM338E2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02333331
    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, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the effect of 24 weeks of bimagrumab treatment on patient physical function assessed by a change in the SPPB total score from baseline to week 25 relative to placebo in older adults with sarcopenia.
    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
    09 Dec 2014
    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: 3
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Denmark: 8
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Japan: 22
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Taiwan: 7
    Country: Number of subjects enrolled
    United States: 135
    Worldwide total number of subjects
    217
    EEA total number of subjects
    22
    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)
    0
    From 65 to 84 years
    189
    85 years and over
    28

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 220 patients were randomized to receive six doses of either BYM338 70 mg, BYM338 210 mg, BYM338 700 mg or the placebo. However, only 217 patients were dosed with BYM338 or placebo due to the withdrawal of three patients who did not meet the inclusion/exclusion criteria prior to receiving the first dose.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BYM338 70 mg
    Arm description
    		 BYM338 70 mg intravenous infusion
    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
    Bimagrumab 70 mg intravenous (i.v.) infusion every 4 weeks for 24-week treatment period

    Arm title
    		 BYM338 210 mg
    Arm description
    		 BYM338 210 mg intravenous infusion
    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
    Bimagrumab 210 mg intravenous (i.v.) infusion every 4 weeks for 24-week treatment period

    Arm title
    		 BYM338 700 mg
    Arm description
    		 BYM338 700 mg intravenous infusion
    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
    Bimagrumab 700 mg intravenous (i.v.) infusion every 4 weeks for 24-week treatment period

    Arm title
    		 Placebo
    Arm description
    		 Placebo intravenous infusion
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    BYM338
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo intravenous (i.v.) infusion every 4 weeks for 24-week treatment period

    Number of subjects in period 1
    		BYM338 70 mg BYM338 210 mg BYM338 700 mg Placebo
    Started
    19
    18
    113
    67
    Completed
    17
    12
    95
    64
    Not completed
    2
    6
    18
    3
         Adverse event, serious fatal
    -
    -
    2
    -
         Physician decision
    -
    1
    -
    -
         Adverse event, non-fatal
    1
    -
    4
    1
         Patient/Guardian Decision
    1
    2
    9
    1
         Protocol Deviation
    -
    3
    2
    1
         Lost to follow-up
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BYM338 70 mg
    Reporting group description
    		 BYM338 70 mg intravenous infusion

    Reporting group title
    BYM338 210 mg
    Reporting group description
    		 BYM338 210 mg intravenous infusion

    Reporting group title
    BYM338 700 mg
    Reporting group description
    		 BYM338 700 mg intravenous infusion

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intravenous infusion

    Reporting group values
    		 BYM338 70 mg BYM338 210 mg BYM338 700 mg Placebo Total
    Number of subjects
    		 19 18 113 67 217
    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)
    		 0 0 0 0 0
        From 65-84 years
    		 15 15 101 58 189
        85 years and over
    		 4 3 12 9 28
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 79.3 ( 5.89 ) 78.0 ( 6.38 ) 79.5 ( 5.46 ) 78.3 ( 5.03 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 9 8 66 43 126
        Male
    		 10 10 47 24 91
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 1 0 1
        Asian
    		 5 3 17 11 36
        Native Hawaiian or Other Pacific Islander
    		 0 0 1 0 1
        Black or African American
    		 3 0 0 1 4
        White
    		 11 14 93 54 172
        More than one race
    		 0 0 0 1 1
        Unknown or Not Reported
    		 0 1 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    BYM338 70 mg
    Reporting group description
    		 BYM338 70 mg intravenous infusion

    Reporting group title
    BYM338 210 mg
    Reporting group description
    		 BYM338 210 mg intravenous infusion

    Reporting group title
    BYM338 700 mg
    Reporting group description
    		 BYM338 700 mg intravenous infusion

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intravenous infusion

    Primary: Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25

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    End point title
    		 Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25
    End point description
    Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function – balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death
    End point type
    Primary
    End point timeframe
    Baseline, week 25
    End point values
    		 BYM338 70 mg BYM338 210 mg BYM338 700 mg Placebo
    Number of subjects analysed
    19
    18
    113
    67
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.1 ( 2.12 )
    7.3 ( 2.11 )
    7.2 ( 1.63 )
    7.3 ( 1.67 )
        Week 25
    8.5 ( 2.48 )
    8.7 ( 1.64 )
    8.7 ( 2.12 )
    8.4 ( 2.25 )
    Statistical analysis title
    		 Change from Baseline in total SPPB Score WK 25
    Comparison groups
    Placebo v BYM338 70 mg
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.274
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 1.21
    Statistical analysis title
    		 Change from Baseline in total SPPB Score WK 25
    Comparison groups
    BYM338 210 mg v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.83
         upper limit
    		 1.35
    Statistical analysis title
    		 Change from Baseline in total SPPB Score WK 25
    Comparison groups
    BYM338 700 mg v Placebo
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.134
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.87

    Secondary: Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance

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    End point title
    		 Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance
    End point description
    Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function
    End point type
    Secondary
    End point timeframe
    Baseline, week 25
    End point values
    		 BYM338 70 mg BYM338 210 mg BYM338 700 mg Placebo
    Number of subjects analysed
    19
    18
    113
    67
    Units: meters
    arithmetic mean (standard deviation)
        Baseline
    293.30 ( 91.842 )
    291.81 ( 82.527 )
    294.30 ( 83.602 )
    312.43 ( 93.924 )
        Week 25
    304.98 ( 102.934 )
    340.71 ( 72.911 )
    315.32 ( 97.020 )
    322.71 ( 103.865 )
    Statistical analysis title
    		 Change from Baseline in 6MWT WK 25
    Comparison groups
    BYM338 70 mg v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.576
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.6
         upper limit
    		 30.95
    Statistical analysis title
    		 Change from Baseline in 6MWT WK 25
    Comparison groups
    BYM338 210 mg v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.178
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.2
         upper limit
    		 61.41
    Statistical analysis title
    		 Change from Baseline in 6MWT WK 25
    Comparison groups
    BYM338 700 mg v Placebo
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.163
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 30.98

    Secondary: Change from Baseline to Week 25 in usual Gait speed (GS) over 4 meters

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    End point title
    		 Change from Baseline to Week 25 in usual Gait speed (GS) over 4 meters
    End point description
    Change from Baseline to Week 25 in usual Gait speed (GS) over 4 meters Gait speed in this study was assessed as part of the SPPB, over a 4 meter distance of a 6 meter course. This test assessed a person’s usual walking speed, which was defined as the speed a person normally walks from one place to another without urgency (e.g., walking down a hallway).
    End point type
    Secondary
    End point timeframe
    baseline, week 25
    End point values
    		 BYM338 70 mg BYM338 210 mg BYM338 700 mg Placebo
    Number of subjects analysed
    19
    18
    113
    67
    Units: m/sec
    arithmetic mean (standard deviation)
        Baseline
    2.37 ( 0.684 )
    2.72 ( 0.752 )
    2.58 ( 0.624 )
    2.70 ( 0.493 )
        Week 25
    3.12 ( 0.857 )
    3.60 ( 0.699 )
    3.30 ( 0.902 )
    3.23 ( 0.838 )
    Statistical analysis title
    		 Change from Baseline in GS over 4 meters WK 25
    Comparison groups
    BYM338 70 mg v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.488
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.1
    Statistical analysis title
    		 Change from Baseline in GS over 4 meters WK 25
    Comparison groups
    BYM338 210 mg v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.055
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.22
    Statistical analysis title
    		 Change from Baseline in GS over 4 meters WK 25
    Comparison groups
    BYM338 700 mg v Placebo
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.161
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.09

    Secondary: Percentage Change from Baseline to Week 25 on appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA)

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    End point title
    		 Percentage Change from Baseline to Week 25 on appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA)
    End point description
    Change from Baseline to Week 25 on appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) Appendicular skeletal muscle index (ASMI) is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual’s lean mass.
    End point type
    Secondary
    End point timeframe
    baseline, week 25
    End point values
    		 BYM338 70 mg BYM338 210 mg BYM338 700 mg Placebo
    Number of subjects analysed
    19
    18
    113
    67
    Units: kg/m2
    arithmetic mean (standard deviation)
        Baseline
    5.99 ( 0.886 )
    5.87 ( 0.795 )
    5.70 ( 0.823 )
    5.55 ( 0.753 )
        Week 25
    6.04 ( 0.947 )
    6.42 ( 0.849 )
    6.10 ( 0.836 )
    5.60 ( 0.717 )
    Statistical analysis title
    		 Change from Baseline of ASMI measured by DXA WK 25
    Comparison groups
    BYM338 70 mg v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.213
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.03
    Statistical analysis title
    		 Change from Baseline of ASMI measured by DXA WK 25
    Comparison groups
    BYM338 210 mg v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 1.09
    Statistical analysis title
    		 Change from Baseline of ASMI measured by DXA WK 25
    Comparison groups
    BYM338 700 mg v Placebo
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.08

    Secondary: Percentage Change from Baseline to Week 25 on Total lean body mass measured by Dual Energy X-ray Absorptiometry (DXA)

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    End point title
    		 Percentage Change from Baseline to Week 25 on Total lean body mass measured by Dual Energy X-ray Absorptiometry (DXA)
    End point description
    Change from Baseline to Week 25 on Total lean body mass measured by Dual Energy X-ray Absorptiometry (DXA) total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.
    End point type
    Secondary
    End point timeframe
    baseline, week 25
    End point values
    		 BYM338 70 mg BYM338 210 mg BYM338 700 mg Placebo
    Number of subjects analysed
    19
    18
    113
    67
    Units: kg
    arithmetic mean (standard deviation)
        Baseline
    37.44 ( 8.507 )
    35.84 ( 7.300 )
    35.39 ( 8.891 )
    33.65 ( 6.890 )
        Week 25
    38.26 ( 8.660 )
    39.52 ( 8.343 )
    37.86 ( 9.064 )
    33.95 ( 6.921 )
    Statistical analysis title
    		 Change from Baseline of Total Lean Body Mass WK 25
    Comparison groups
    BYM338 70 mg v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.458
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.02
    Statistical analysis title
    		 Change from Baseline of Total Lean Body Mass WK 25
    Comparison groups
    BYM338 210 mg v Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 1.08
    Statistical analysis title
    		 Change from Baseline of Total Lean Body Mass WK 25
    Comparison groups
    BYM338 700 mg v Placebo
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.07

    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
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    BYM338 70 mg
    Reporting group description
    		 BYM338 70 mg

    Reporting group title
    BYM338 210 mg
    Reporting group description
    		 BYM338 210 mg

    Reporting group title
    BYM338 700 mg
    Reporting group description
    		 BYM338 700 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 BYM338 70 mg BYM338 210 mg BYM338 700 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 18 (16.67%)
    14 / 113 (12.39%)
    5 / 67 (7.46%)
         number of deaths (all causes)
    0
    0
    2
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lung
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         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
    Renal neoplasm
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         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
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Hypertensive crisis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         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
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Dyspnoea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Pulmonary oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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 arrest
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (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
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Injury, poisoning and procedural complications
    Aortic injury
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Spinal fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Cardiac failure congestive
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Myocardial infarction
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (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
    Pulseless electrical activity
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Ischaemic stroke
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Syncope
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         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
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         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
    Myalgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         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
    Erysipelas
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Influenza
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         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 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Decreased appetite
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (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
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 BYM338 70 mg BYM338 210 mg BYM338 700 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 19 (63.16%)
    13 / 18 (72.22%)
    94 / 113 (83.19%)
    41 / 67 (61.19%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    9 / 113 (7.96%)
    4 / 67 (5.97%)
         occurrences all number
    0
    1
    13
    5
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 18 (5.56%)
    5 / 113 (4.42%)
    0 / 67 (0.00%)
         occurrences all number
    1
    1
    6
    0
    Infusion site swelling
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 113 (0.88%)
    1 / 67 (1.49%)
         occurrences all number
    0
    1
    1
    1
    Oedema
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    4 / 113 (3.54%)
    0 / 67 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Productive cough
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Product issues
    Device dislocation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    4 / 113 (3.54%)
    0 / 67 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    3 / 113 (2.65%)
    1 / 67 (1.49%)
         occurrences all number
    1
    0
    3
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         occurrences all number
    1
    0
    0
    1
    Lipase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    6 / 113 (5.31%)
    0 / 67 (0.00%)
         occurrences all number
    0
    0
    7
    0
    Liver function test increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Contusion
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    5 / 113 (4.42%)
    7 / 67 (10.45%)
         occurrences all number
    0
    1
    7
    8
    Fall
         subjects affected / exposed
    2 / 19 (10.53%)
    3 / 18 (16.67%)
    28 / 113 (24.78%)
    24 / 67 (35.82%)
         occurrences all number
    6
    4
    38
    46
    Muscle strain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    2 / 113 (1.77%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Skin abrasion
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    2 / 67 (2.99%)
         occurrences all number
    1
    0
    1
    2
    Wound
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 18 (0.00%)
    3 / 113 (2.65%)
    0 / 67 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Palpitations
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    2 / 113 (1.77%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    6 / 113 (5.31%)
    0 / 67 (0.00%)
         occurrences all number
    0
    0
    7
    0
    Dysgeusia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    4 / 113 (3.54%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    4
    0
    Headache
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    5 / 113 (4.42%)
    3 / 67 (4.48%)
         occurrences all number
    0
    0
    5
    3
    Hypoaesthesia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Muscle contractions involuntary
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    3 / 113 (2.65%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Presyncope
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    3 / 113 (2.65%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    2 / 67 (2.99%)
         occurrences all number
    2
    0
    1
    2
    Eye disorders
    Trichiasis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    6 / 113 (5.31%)
    1 / 67 (1.49%)
         occurrences all number
    0
    1
    6
    1
    Dental necrosis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 18 (16.67%)
    22 / 113 (19.47%)
    2 / 67 (2.99%)
         occurrences all number
    2
    5
    28
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         occurrences all number
    1
    0
    0
    1
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    8 / 113 (7.08%)
    0 / 67 (0.00%)
         occurrences all number
    0
    0
    9
    0
    Toothache
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    4 / 113 (3.54%)
    0 / 67 (0.00%)
         occurrences all number
    0
    0
    7
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 18 (16.67%)
    3 / 113 (2.65%)
    0 / 67 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Actinic keratosis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eczema
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    2 / 113 (1.77%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Eczema asteatotic
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    1 / 67 (1.49%)
         occurrences all number
    1
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    2 / 113 (1.77%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Rash
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    5 / 113 (4.42%)
    0 / 67 (0.00%)
         occurrences all number
    0
    0
    7
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin fissures
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Renal and urinary disorders
    Lower urinary tract symptoms
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nocturia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Endocrine disorders
    Androgen deficiency
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 113 (0.88%)
    2 / 67 (2.99%)
         occurrences all number
    0
    2
    1
    2
    Back pain
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 18 (11.11%)
    5 / 113 (4.42%)
    3 / 67 (4.48%)
         occurrences all number
    1
    2
    5
    3
    Muscle spasms
         subjects affected / exposed
    4 / 19 (21.05%)
    5 / 18 (27.78%)
    37 / 113 (32.74%)
    10 / 67 (14.93%)
         occurrences all number
    6
    7
    50
    12
    Musculoskeletal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    2 / 113 (1.77%)
    1 / 67 (1.49%)
         occurrences all number
    1
    0
    2
    1
    Myalgia
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 18 (5.56%)
    3 / 113 (2.65%)
    2 / 67 (2.99%)
         occurrences all number
    1
    2
    3
    2
    Osteoarthritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    4 / 113 (3.54%)
    2 / 67 (2.99%)
         occurrences all number
    0
    0
    4
    2
    Pain in extremity
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    6 / 113 (5.31%)
    3 / 67 (4.48%)
         occurrences all number
    0
    1
    7
    4
    Plantar fasciitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    6 / 113 (5.31%)
    2 / 67 (2.99%)
         occurrences all number
    1
    0
    7
    2
    Fungal skin infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gingivitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 18 (5.56%)
    5 / 113 (4.42%)
    0 / 67 (0.00%)
         occurrences all number
    4
    1
    6
    0
    Periodontitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Sinusitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    4 / 113 (3.54%)
    1 / 67 (1.49%)
         occurrences all number
    0
    0
    5
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 18 (11.11%)
    5 / 113 (4.42%)
    5 / 67 (7.46%)
         occurrences all number
    1
    2
    5
    5
    Urinary tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    6 / 113 (5.31%)
    1 / 67 (1.49%)
         occurrences all number
    1
    0
    6
    1
    Vaginal infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 113 (0.00%)
    0 / 67 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    5 / 113 (4.42%)
    1 / 67 (1.49%)
         occurrences all number
    0
    0
    5
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 18 (5.56%)
    5 / 113 (4.42%)
    0 / 67 (0.00%)
         occurrences all number
    1
    1
    6
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    2 / 113 (1.77%)
    0 / 67 (0.00%)
         occurrences all number
    0
    1
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 May 2015
    Amendment 1:The purpose of this amendment was to correct minor inconsistencies identified during health authority and ethics committee reviews, and to provide some clarifications on study assessments. At the time of implementing this amendment, 3 patients had begun treatment; none were affected by changes made to the protocol. The changes described in this amendment did not affect the objectives of the study, impact the safety of the patients or change the analysis of the study data. Some adjustments were made to the inclusion and exclusion criteria as a result of experience with the population required for this study.
    06 Sep 2016
    Amendment 2: The purpose of this amendment is to align the study design and endpoints with progress made in the field of sarcopenia and the bimagrumab program since the original protocol was submitted, integrate new safety data from recently completed bimagrumab studies, facilitate recruitment, and reduce patient and site burden where possible.
    04 Oct 2017
    Amendment 3: The primary purpose of this amendment was to present a new safety observation and the resultant modifications to the protocol, and to adjust the sample size to enable program decision making at the completion of Part A. In addition, editorial revisions were made to clarify the terminology of the oral nutritional supplement and to improve understanding in other areas of the text.

    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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