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    Clinical Trial Results:
    High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS)

    Summary
    EudraCT number
    		 2017-003236-37
    Trial protocol
    		 CZ   HU   IT  
    Global end of trial date
    21 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2021
    First version publication date
    12 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20160184
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03570697
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.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
    21 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in subjects with non-ST-elevation acute coronary syndrome (NSTE-ACS) who are taking maximally tolerated statin therapy.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and with: - Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines - Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines - Applicable ICH laws and regulations The investigator or his/her delegated representative explained to the subject, or his/her legally authorized representative, the aims, methods, anticipated benefits, and potential hazards of the study before any protocol-specific screening procedures or any investigational product(s) were administered, and answered all questions regarding the study.
    Background therapy
    		 High-intensity statin treatment with atorvastatin ≥ 40 mg daily or equivalent as background therapy Investigators up-titrated statin therapy to the maximally tolerated dose, in accordance with local guidelines, prior to randomization.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Czechia: 10
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hungary: 45
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Netherlands: 78
    Worldwide total number of subjects
    164
    EEA total number of subjects
    162
    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)
    104
    From 65 to 84 years
    60
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 23 research centers in Australia (2), Czech Republic (2), Germany (2), Hungary (4), Italy (6), and the Netherlands (7), from November 2018 to December 2019.

    Pre-assignment
    Screening details
    		 Participants were randomized 1:1 into 2 treatment groups: evolocumab 420 mg subcutaneously (SC) monthly (QM) or placebo SC QM. Randomization was stratified by current statin use (> 4 weeks or ≤ 4 weeks) at screening.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo was administered in accordance with instructions in the Investigational Product Instruction Manual (IPIM) and the Information for Use (IFU). The subject (or designee) must have had demonstrated competency, as per site judgment, at administration of SC injections before self-administration was permitted.

    Arm title
    		 Evolocumab
    Arm description
    		 Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Evolocumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Evolocumab was administered in accordance with instructions in the IPIM and the IFU. The subject (or designee) must have had demonstrated competency, as per site judgment, at administration of SC injections before self-administration was permitted.

    Number of subjects in period 1
    		Placebo Evolocumab
    Started
    82
    82
    Received at least 1 dose of study drug
    81
    80
    Completed
    76
    79
    Not completed
    6
    3
         Adverse event, serious fatal
    2
    -
         Consent withdrawn by subject
    4
    2
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.

    Reporting group title
    Evolocumab
    Reporting group description
    		 Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.

    Reporting group values
    		 Placebo Evolocumab Total
    Number of subjects
    		 82 82 164
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.4 ± 9.4 61.1 ± 10.0 -
    Sex: Female, Male
    Units:
        Female
    		 26 20 46
        Male
    		 56 62 118
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 4 5
        Not Hispanic or Latino
    		 81 78 159
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 1 1 2
        White
    		 80 79 159
        Other, Not Specified
    		 1 2 3
    Stratification Factor: Statin Use at Screening
    Units: Subjects
        > 4 weeks of statin use
    		 20 19 39
        ≤ 4 weeks of statin use
    		 62 63 125
    Minimum Fibrous Cap Thickness (FCT)
    Minimum FCT as determined by optical coherence tomography (OCT). Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation. Full Analysis Set; n=81, 80
    Units: µm
        arithmetic mean (standard deviation)
    		 54.6 ± 15.1 56.6 ± 17.8 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.

    Reporting group title
    Evolocumab
    Reporting group description
    		 Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.

    Primary: Absolute Change From Baseline in Minimum FCT

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    End point title
    		 Absolute Change From Baseline in Minimum FCT
    End point description
    Absolute change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation. Full Analysis Set: all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline, week 50
    End point values
    		 Placebo Evolocumab
    Number of subjects analysed
    81
    80
    Units: µm
        least squares mean (standard error)
    21.5 ± 5.2
    42.7 ± 5.1
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Evolocumab
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.015
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    21.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.7
         upper limit
    		 37.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.9

    Secondary: Percent Change From Baseline in Minimum FCT

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    End point title
    		 Percent Change From Baseline in Minimum FCT
    End point description
    Percent change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation. Full Analysis Set: all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, week 50
    End point values
    		 Placebo Evolocumab
    Number of subjects analysed
    81
    80
    Units: percent change
        least squares mean (standard error)
    44.30 ± 11.76
    81.76 ± 10.94
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Evolocumab
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.041
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    37.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.63
         upper limit
    		 73.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    17.04

    Secondary: Absolute Change From Baseline in Mean Minimum FCT

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    End point title
    		 Absolute Change From Baseline in Mean Minimum FCT
    End point description
    Absolute change from baseline in mean minimum FCT for all images assessed in an individual participant as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation. Full Analysis Set: all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, week 50
    End point values
    		 Placebo Evolocumab
    Number of subjects analysed
    81
    80
    Units: µm
        least squares mean (standard error)
    29.78 ± 6.88
    62.29 ± 5.95
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Evolocumab
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    32.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.67
         upper limit
    		 52.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.52

    Secondary: Absolute Change From Baseline in the Maximum Lipid Arc

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    End point title
    		 Absolute Change From Baseline in the Maximum Lipid Arc
    End point description
    Absolute change from baseline in the maximum lipid arc in a matched segment of artery as determined by OCT. Lower value of lipid arc indicates a better situation. Full Analysis Set: all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, week 50
    End point values
    		 Placebo Evolocumab
    Number of subjects analysed
    80
    81
    Units: degrees
        least squares mean (standard error)
    -31.4 ± 9.0
    -57.5 ± 7.4
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Evolocumab
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.032
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -49.6
         upper limit
    		 -2.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.4

    Secondary: Absolute Change from Baseline in Minimum FCT in Lipid Rich Plaques

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    End point title
    		 Absolute Change from Baseline in Minimum FCT in Lipid Rich Plaques
    End point description
    Absolute change from baseline in minimum FCT in lipid rich plaques as determined by OCT. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Higher value of FCT indicates a better situation. Full Analysis Set: all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, week 50
    End point values
    		 Placebo Evolocumab
    Number of subjects analysed
    81
    80
    Units: μm
        least squares mean (standard error)
    24.6 ± 5.5
    40.6 ± 5.5
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Evolocumab
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.036
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 31
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.5

    Secondary: Absolute Change from Baseline in Maximum Lipid Arc in Lipid Rich Plaques

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    End point title
    		 Absolute Change from Baseline in Maximum Lipid Arc in Lipid Rich Plaques
    End point description
    Absolute change from baseline in maximum lipid arc in lipid rich plaques. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Lower value of lipid arc indicates a better situation. Full Analysis Set: all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, week 50
    End point values
    		 Placebo Evolocumab
    Number of subjects analysed
    81
    80
    Units: degrees
        least squares mean (standard error)
    -31.9 ± 8.1
    -61.9 ± 7.9
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Evolocumab
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -50.5
         upper limit
    		 -9.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.4

    Secondary: Absolute Change From Baseline in Lipid Core Length in Lipid Rich Plaques

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    End point title
    		 Absolute Change From Baseline in Lipid Core Length in Lipid Rich Plaques
    End point description
    Absolute change from baseline in lipid core length in lipid rich plaques. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Lower value of lipid core length indicates a better situation. Full Analysis Set: all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, week 50
    End point values
    		 Placebo Evolocumab
    Number of subjects analysed
    81
    80
    Units: mm
        least squares mean (standard error)
    -3.33 ± 0.64
    -5.76 ± 0.61
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Evolocumab
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -2.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.04
         upper limit
    		 -0.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.81

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
    Adverse event reporting additional description
    Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    EvoMab 420 MG QM
    Reporting group description
    		 Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.

    Reporting group title
    Placebo QM
    Reporting group description
    		 Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.

    Serious adverse events
    		 EvoMab 420 MG QM Placebo QM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 80 (16.25%)
    16 / 81 (19.75%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary hypertensive crisis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Carotid artery restenosis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 80 (0.00%)
    3 / 81 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Normocytic anaemia
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Enterococcal infection
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis staphylococcal
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 EvoMab 420 MG QM Placebo QM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 80 (38.75%)
    30 / 81 (37.04%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 80 (7.50%)
    5 / 81 (6.17%)
         occurrences all number
    7
    5
    Hypotension
         subjects affected / exposed
    3 / 80 (3.75%)
    1 / 81 (1.23%)
         occurrences all number
    3
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    4 / 80 (5.00%)
    7 / 81 (8.64%)
         occurrences all number
    4
    7
    Bradycardia
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 80 (3.75%)
    2 / 81 (2.47%)
         occurrences all number
    3
    2
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    3 / 80 (3.75%)
    4 / 81 (4.94%)
         occurrences all number
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 80 (2.50%)
    3 / 81 (3.70%)
         occurrences all number
    2
    3
    Epistaxis
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 81 (0.00%)
         occurrences all number
    3
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 80 (2.50%)
    2 / 81 (2.47%)
         occurrences all number
    3
    2
    Rhinorrhoea
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 81 (2.47%)
         occurrences all number
    1
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Muscle spasms
         subjects affected / exposed
    0 / 80 (0.00%)
    3 / 81 (3.70%)
         occurrences all number
    0
    3
    Myalgia
         subjects affected / exposed
    5 / 80 (6.25%)
    6 / 81 (7.41%)
         occurrences all number
    6
    6
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 81 (2.47%)
         occurrences all number
    1
    2
    Pneumonia
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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