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    Clinical Trial Results:
    A 24 week off drug extension, parallel group, study assessing durability of effect on skeletal muscle strength and function following a 6-month double-blind, placebo controlled study evaluating bimagrumab in older adults with sarcopenia (InvestiGAIT extension)

    Summary
    EudraCT number
    		 2015-000471-27
    Trial protocol
    		 ES   BE   DK  
    Global end of trial date
    03 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2019
    First version publication date
    13 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CBYM338E2202E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02468674
    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
    03 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the durability of effect of bimagrumab (BYM338) on physical function as measured by the Short Physical Performance Battery (SPPB) total score at Week 49.
    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
    22 Jul 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Japan: 16
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Taiwan: 5
    Country: Number of subjects enrolled
    United States: 105
    Worldwide total number of subjects
    160
    EEA total number of subjects
    11
    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
    131
    85 years and over
    29

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study was conducted in 30 centers in 12 countries: Australia (1), Belgium (1), Czech Republic (1), Denmark (1), France (2), Japan (10), Russia (4), South Korea (1), Spain (2), Switzerland (1), Taiwan (1), United States (5).

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Population I: BYM338 700 mg
    Arm description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimagrumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 doses of bimagrumab 700 mg one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Arm title
    		 Population I BYM338: 700 mg to Placebo
    Arm description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 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
    6 doses of bimagrumab 700 mg matching placebo one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Arm title
    		 Population I: BYM338 210 mg
    Arm description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimagrumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 doses of bimagrumab 210 mg one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Arm title
    		 Population I BYM338: 210 mg to Placebo
    Arm description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 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
    6 doses of bimagrumab 210 mg mg matching placebo one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Arm title
    		 Population I: BYM338 70 mg
    Arm description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimagrumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 doses of bimagrumab 70 mg one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Arm title
    		 Population I: BYM338 70 mg to Placebo
    Arm description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 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
    6 doses of bimagrumab 70 mg matching placebo one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Arm title
    		 Population I: Placebo
    Arm description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 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
    6 doses of bimagrumab 70 mg, 210 mg or 700 mg matching placebo one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Arm title
    		 Population: II BYM338 700 mg
    Arm description
    		 Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Population: II Placebo
    Arm description
    		 Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Population I: BYM338 700 mg Population I BYM338: 700 mg to Placebo Population I: BYM338 210 mg Population I BYM338: 210 mg to Placebo Population I: BYM338 70 mg Population I: BYM338 70 mg to Placebo Population I: Placebo Population: II BYM338 700 mg Population: II Placebo
    Started
    5
    5
    5
    4
    7
    7
    15
    69
    43
    Completed
    4
    5
    5
    3
    6
    6
    14
    65
    40
    Not completed
    1
    0
    0
    1
    1
    1
    1
    4
    3
         Physician decision
    -
    -
    -
    -
    -
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    1
    -
    1
    -
    -
    -
         Patient/Guardian Decision
    -
    -
    -
    -
    1
    -
    -
    2
    1
         Protocol Deviation
    -
    -
    -
    -
    -
    -
    -
    1
    1
         Lost to follow-up
    1
    -
    -
    -
    -
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Population I: BYM338 700 mg
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I BYM338: 700 mg to Placebo
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I: BYM338 210 mg
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I BYM338: 210 mg to Placebo
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I: BYM338 70 mg
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I: BYM338 70 mg to Placebo
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I: Placebo
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population: II BYM338 700 mg
    Reporting group description
    		 Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.

    Reporting group title
    Population: II Placebo
    Reporting group description
    		 Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.

    Reporting group values
    		 Population I: BYM338 700 mg Population I BYM338: 700 mg to Placebo Population I: BYM338 210 mg Population I BYM338: 210 mg to Placebo Population I: BYM338 70 mg Population I: BYM338 70 mg to Placebo Population I: Placebo Population: II BYM338 700 mg Population: II Placebo Total
    Number of subjects
    		 5 5 5 4 7 7 15 69 43 160
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0 0 0 0 0
        From 65-84 years
    		 4 3 5 4 6 5 13 56 35 131
        85 years and over
    		 1 2 0 0 1 2 2 13 8 29
    Age Continuous
    Age Continuous for Population I and Population II
    Units: years
        arithmetic mean (standard deviation)
    		 80.0 ± 4.90 79.4 ± 7.27 79.0 ± 1.58 74.8 ± 2.63 77.6 ± 6.75 81.6 ± 4.58 79.9 ± 4.22 79.8 ± 5.05 78.2 ± 5.29 -
    Sex: Female, Male
    Gender for Population I and Population II
    Units: Subjects
        Female
    		 1 2 2 2 3 5 8 40 29 92
        Male
    		 4 3 3 2 4 2 7 29 14 68
    Race/Ethnicity, Customized
    Race/Ethnicity for Population I and Population II
    Units: Subjects
        Asian
    		 1 0 0 1 2 2 6 11 3 26
        Black
    		 0 0 0 0 1 1 1 0 0 3
        Caucasian
    		 4 5 5 3 4 4 8 56 40 129
        Native American
    		 0 0 0 0 0 0 0 1 0 1
        Pacific Islander
    		 0 0 0 0 0 0 0 1 0 1
    Population I & II: Short Physical Performance Battery (SPPB) total score at Week 25
    Baseline Extension Visit = Week 25. SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
    Units: Total scores
        arithmetic mean (standard deviation)
    		 8.8 ± 2.17 10.4 ± 1.34 8.6 ± 1.67 8.5 ± 1.91 8.9 ± 2.04 8.0 ± 3.27 9.1 ± 1.58 8.5 ± 2.17 8.2 ± 2.25 -
    Population I & II: 6-minute walking distance (6MWT) at Week 25
    Baseline Extension Visit = Week 25. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway.
    Units: meters
        arithmetic mean (standard deviation)
    		 302.73 ± 130.22 353.10 ± 66.17 313.67 ± 71.39 361.07 ± 80.11 305.24 ± 111.34 286.94 ± 119.37 352.18 ± 123.55 307.84 ± 99.96 315.61 ± 95.74 -
    Population I & II: Gait speed at Week 25
    Baseline Extension Visit = Week 25. Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
    Units: m/sec
        arithmetic mean (standard deviation)
    		 0.8 ± 0.20 0.9 ± 0.13 0.9 ± 0.27 0.9 ± 0.12 0.8 ± 0.19 0.6 ± 0.28 0.8 ± 0.19 0.8 ± 0.23 0.8 ± 0.22 -

    End points

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    End points reporting groups
    Reporting group title
    Population I: BYM338 700 mg
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I BYM338: 700 mg to Placebo
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I: BYM338 210 mg
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I BYM338: 210 mg to Placebo
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I: BYM338 70 mg
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I: BYM338 70 mg to Placebo
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population I: Placebo
    Reporting group description
    		 Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo – one approximately every four weeks – over a 20-week period providing drug exposure for a total of 24 weeks.

    Reporting group title
    Population: II BYM338 700 mg
    Reporting group description
    		 Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.

    Reporting group title
    Population: II Placebo
    Reporting group description
    		 Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.

    Primary: Population I: Short Physical Performance Battery (SPPB) total score at Week 49

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    End point title
    		 Population I: Short Physical Performance Battery (SPPB) total score at Week 49 [1]
    End point description
    SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
    End point type
    Primary
    End point timeframe
    Week 49
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population I: BYM338 700 mg Population I BYM338: 700 mg to Placebo Population I: BYM338 210 mg Population I BYM338: 210 mg to Placebo Population I: BYM338 70 mg Population I: BYM338 70 mg to Placebo Population I: Placebo
    Number of subjects analysed
    4
    5
    5
    3
    6
    6
    14
    Units: Total scores
        arithmetic mean (standard deviation)
    8.8 ± 3.86
    10.2 ± 1.92
    8.0 ± 2.35
    8.0 ± 2.65
    9.5 ± 2.17
    7.5 ± 3.78
    9.6 ± 1.83
    Statistical analysis title
    		 Population I: SPPB total score at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I BYM338: 700 mg to Placebo
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.759
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: SPPB total score at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I BYM338: 210 mg to Placebo
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: SPPB total score at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: BYM338 70 mg to Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.144
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: SPPB total score at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I: Placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.648
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: SPPB total score at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I: Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.929
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: SPPB total score at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.53
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: Population II: Short Physical Performance Battery (SPPB) total score at Week 49

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    End point title
    		 Population II: Short Physical Performance Battery (SPPB) total score at Week 49 [2]
    End point description
    SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
    End point type
    Primary
    End point timeframe
    Week 49
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population: II BYM338 700 mg Population: II Placebo
    Number of subjects analysed
    65
    40
    Units: Total scores
        arithmetic mean (standard deviation)
    8.6 ± 2.40
    8.8 ± 1.55
    Statistical analysis title
    		 Population II: SPPB total score at Week 49
    Comparison groups
    Population: II BYM338 700 mg v Population: II Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.839
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Population I: 6-minute walking distance (6MWT) at Week 49

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    End point title
    		 Population I: 6-minute walking distance (6MWT) at Week 49 [3]
    End point description
    The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
    End point type
    Secondary
    End point timeframe
    Week 49
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population I: BYM338 700 mg Population I BYM338: 700 mg to Placebo Population I: BYM338 210 mg Population I BYM338: 210 mg to Placebo Population I: BYM338 70 mg Population I: BYM338 70 mg to Placebo Population I: Placebo
    Number of subjects analysed
    5
    5
    5
    4
    7
    7
    15
    Units: meters
        arithmetic mean (standard deviation)
    318.2 ± 159.55
    354.1 ± 69.98
    304.1 ± 63.05
    361.5 ± 144.53
    316.1 ± 97.87
    273.4 ± 154.03
    368.7 ± 108.37
    Statistical analysis title
    		 Population I: 6MWT at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I BYM338: 700 mg to Placebo
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.669
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: 6MWT at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I BYM338: 210 mg to Placebo
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.773
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: 6MWT at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: BYM338 70 mg to Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.29
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: 6MWT at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.766
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: 6MWT at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.885
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: 6MWT at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.84
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Population II: 6-minute walking distance (6MWT) at Week 49

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    End point title
    		 Population II: 6-minute walking distance (6MWT) at Week 49 [4]
    End point description
    The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
    End point type
    Secondary
    End point timeframe
    Week 49
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population: II BYM338 700 mg Population: II Placebo
    Number of subjects analysed
    69
    43
    Units: meters
        arithmetic mean (standard deviation)
    321.2 ± 105.13
    323.1 ± 96.47
    Statistical analysis title
    		 Population II: 6MWT at Week 49
    Comparison groups
    Population: II BYM338 700 mg v Population: II Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.367
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Population I: Gait speed at Week 49

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    End point title
    		 Population I: Gait speed at Week 49 [5]
    End point description
    Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
    End point type
    Secondary
    End point timeframe
    Week 49
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population I: BYM338 700 mg Population I BYM338: 700 mg to Placebo Population I: BYM338 210 mg Population I BYM338: 210 mg to Placebo Population I: BYM338 70 mg Population I: BYM338 70 mg to Placebo Population I: Placebo
    Number of subjects analysed
    5
    5
    5
    4
    7
    7
    15
    Units: m/sec
        arithmetic mean (standard deviation)
    0.8 ± 0.35
    1.0 ± 0.18
    0.9 ± 0.17
    1.1 ± 0.24
    0.9 ± 0.15
    0.7 ± 0.35
    0.8 ± 0.18
    Statistical analysis title
    		 Population I: Gait speed at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I BYM338: 700 mg to Placebo
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.875
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: Gait speed at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I BYM338: 210 mg to Placebo
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.909
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: Gait speed at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: BYM338 70 mg to Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.168
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: Gait speed at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.632
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: Gait speed at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.31
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: Gait speed at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.321
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Population II: Gait speed at Week 49

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    End point title
    		 Population II: Gait speed at Week 49 [6]
    End point description
    Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
    End point type
    Secondary
    End point timeframe
    Week 49
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population: II BYM338 700 mg Population: II Placebo
    Number of subjects analysed
    69
    43
    Units: m/sec
        arithmetic mean (standard deviation)
    0.9 ± 0.24
    0.9 ± 0.17
    Statistical analysis title
    		 Population II: Gait speed at Week 49
    Statistical analysis description
    Population II: Gait speed at Week 49
    Comparison groups
    Population: II BYM338 700 mg v Population: II Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.395
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Population I: Appendicular Skeletal Muscle Index (ASMI) as measured by dual energy X-ray absorptiometry (DXA) at Week 49

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    End point title
    		 Population I: Appendicular Skeletal Muscle Index (ASMI) as measured by dual energy X-ray absorptiometry (DXA) at Week 49 [7]
    End point description
    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
    Week 49
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population I: BYM338 700 mg Population I BYM338: 700 mg to Placebo Population I: BYM338 210 mg Population I BYM338: 210 mg to Placebo Population I: BYM338 70 mg Population I: BYM338 70 mg to Placebo Population I: Placebo
    Number of subjects analysed
    5
    5
    5
    4
    7
    7
    15
    Units: kg/m2
        geometric mean (geometric coefficient of variation)
    6.6 ± 7.22
    6.0 ± 14.05
    6.1 ± 8.08
    5.8 ± 15.08
    5.9 ± 14.19
    5.2 ± 14.85
    5.6 ± 15.21
    Statistical analysis title
    		 Population I: ASMI at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I BYM338: 700 mg to Placebo
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.12
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: ASMI at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I BYM338: 210 mg to Placebo
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.297
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: ASMI at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: BYM338 70 mg to Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.074
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: ASMI at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.022
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: ASMI at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.106
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: ASMI at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.211
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Population II: Appendicular Skeletal Muscle Index (ASMI) as measured by dual energy X-ray absorptiometry (DXA) at Week 49

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    End point title
    		 Population II: Appendicular Skeletal Muscle Index (ASMI) as measured by dual energy X-ray absorptiometry (DXA) at Week 49 [8]
    End point description
    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
    Week 49
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population: II BYM338 700 mg Population: II Placebo
    Number of subjects analysed
    69
    43
    Units: kg/m2
        geometric mean (geometric coefficient of variation)
    5.6 ± 14.36
    5.5 ± 12.46
    Statistical analysis title
    		 Population II: ASMI at Week 49
    Comparison groups
    Population: II BYM338 700 mg v Population: II Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Population I: Total Lean Body Mass (LBM) as measured by dual energy X-ray absorptiometry (DXA) at Week 49

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    End point title
    		 Population I: Total Lean Body Mass (LBM) as measured by dual energy X-ray absorptiometry (DXA) at Week 49 [9]
    End point description
    LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
    End point type
    Secondary
    End point timeframe
    Week 49
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population I: BYM338 700 mg Population I BYM338: 700 mg to Placebo Population I: BYM338 210 mg Population I BYM338: 210 mg to Placebo Population I: BYM338 70 mg Population I: BYM338 70 mg to Placebo Population I: Placebo
    Number of subjects analysed
    5
    5
    5
    4
    7
    7
    15
    Units: kg
        geometric mean (geometric coefficient of variation)
    41.4 ± 21.11
    34.0 ± 17.76
    35.5 ± 15.39
    32.6 ± 25.23
    34.9 ± 21.16
    34.0 ± 18.47
    32.6 ± 17.95
    Statistical analysis title
    		 Population I: LBM at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I BYM338: 700 mg to Placebo
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.084
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: LBM at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I BYM338: 210 mg to Placebo
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.283
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: LBM at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: BYM338 70 mg to Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.323
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: LBM at Week 49
    Comparison groups
    Population I: BYM338 700 mg v Population I: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.018
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: LBM at Week 49
    Comparison groups
    Population I: BYM338 210 mg v Population I: Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.179
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Population I: LBM at Week 49
    Comparison groups
    Population I: BYM338 70 mg v Population I: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.227
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: Population II: Total Lean Body Mass (LBM) as measured by dual energy X-ray absorptiometry (DXA) at Week 49

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    End point title
    		 Population II: Total Lean Body Mass (LBM) as measured by dual energy X-ray absorptiometry (DXA) at Week 49 [10]
    End point description
    LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
    End point type
    Secondary
    End point timeframe
    Week 49
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: To facilitate different analysis on patients enrolled before and after the protocol amendment 1, two populations are defined as below: · Population I: Patients enrolled prior to protocol amendment 1 · Population II: Patients enrolled after protocol amendment 1.
    End point values
    		 Population: II BYM338 700 mg Population: II Placebo
    Number of subjects analysed
    69
    43
    Units: kg
        geometric mean (geometric coefficient of variation)
    34.9 ± 25.01
    33.7 ± 20.40
    Statistical analysis title
    		 Population II: LBM at Week 49
    Comparison groups
    Population: II BYM338 700 mg v Population: II Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
    Adverse event reporting additional description
    Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Population I BYM338 700 mg
    Reporting group description
    		 Population I BYM338 700 mg

    Reporting group title
    Population I BYM338 700 mg to Placebo
    Reporting group description
    		 Population I BYM338 700 mg to Placebo

    Reporting group title
    Population I BYM338 210 mg
    Reporting group description
    		 Population I BYM338 210 mg

    Reporting group title
    Population I BYM338 210 mg to Placebo
    Reporting group description
    		 Population I BYM338 210 mg to Placebo

    Reporting group title
    Population I BYM338 70 mg
    Reporting group description
    		 Population I BYM338 70 mg

    Reporting group title
    Population I BYM338 70 mg to Placebo
    Reporting group description
    		 Population I BYM338 70 mg to Placebo

    Reporting group title
    Population I Placebo
    Reporting group description
    		 Population I Placebo

    Reporting group title
    Population: II BYM338 700 mg
    Reporting group description
    		 Population: II BYM338 700 mg

    Reporting group title
    Population: II Placebo
    Reporting group description
    		 Population: II Placebo

    Serious adverse events
    		 Population I BYM338 700 mg Population I BYM338 700 mg to Placebo Population I BYM338 210 mg Population I BYM338 210 mg to Placebo Population I BYM338 70 mg Population I BYM338 70 mg to Placebo Population I Placebo Population: II BYM338 700 mg Population: II Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    2 / 7 (28.57%)
    2 / 15 (13.33%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gallbladder cancer
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Population I BYM338 700 mg Population I BYM338 700 mg to Placebo Population I BYM338 210 mg Population I BYM338 210 mg to Placebo Population I BYM338 70 mg Population I BYM338 70 mg to Placebo Population I Placebo Population: II BYM338 700 mg Population: II Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 5 (80.00%)
    4 / 5 (80.00%)
    3 / 5 (60.00%)
    2 / 4 (50.00%)
    5 / 7 (71.43%)
    3 / 7 (42.86%)
    11 / 15 (73.33%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Skin papilloma
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Prostatic dysplasia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Product issues
    Device loosening
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Body mass index decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Contusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 15 (13.33%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Fall
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    6 / 15 (40.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    3
    1
    0
    2
    2
    0
    8
    0
    0
    Head injury
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    0
    Muscle contusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Cardiac disorders
    Bundle branch block left
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Macular degeneration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Chronic gastritis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Large intestine polyp
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Renal cyst
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Back pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    1
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 15 (13.33%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tinea versicolour
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
    0 / 69 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Apr 2017
    1. Re-focus of the study on assessing the durability of effect of bimagrumab over a 24 week period off drug. 2. Study was reduced to 24 weeks with site visits every 12 weeks instead of every 4 weeks and phone calls were added in between visits to promote adherence and to record falls or other associated feedback from study participants 3. Addition of a planned interim analysis 4. The need for unblinding of core treatment code for newly enrolled patients followed the core study protocol procedure 5. All IMP related sections were only applicable to those patients enrolled under the original protocol version 6. Inclusion/exclusion criteria were simplified as only patients willing and having fully completed the 24 weeks of core study treatment are eligible 7. As part of the alignment between the core and the extension studies, the following key changes were implemented in this extension study: a. The SPPB replaced the 6MWT as primary endpoint, the 6MWT changed to a secondary endpoint b. The 400 meter walk test was removed c. Echocardiography was eliminated and overall cardiac monitoring was reduced from a level of intense monitoring to one reflecting standard of care following the results of the dedicated profiling cardiac safety study d. Additional safety monitoring guidance for patients with change in body weight since the core study baseline of +/- 5% e. Removal of certain central laboratory assessments (i.e. urinalysis, coagulation measurement) f. e-devices diaries (falls and exercises) are replaced by paper diaries which are easier to use for this patient population g. Addition of the PAISs instrument, a Novartis developed PRO and the necessary battery of questionnaires to contribute to its validation (i.e. PGIC, PGIS, SF-36v2, EQ-5D-5L) h. The frequency of the DXA assessment was reduced to a final one at the EOS only

    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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