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    Clinical Trial Results:
    Immune response to COVID-19 Vaccination in people with Diabetes Mellitus - COVAC-DM study

    Summary
    EudraCT number
    2021-001459-15
    Trial protocol
    AT  
    Global end of trial date
    24 Jun 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Nov 2023
    First version publication date
    15 Nov 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HS-2021-02
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Neue Stiftingtalstrasse 6, Graz, Austria, 8010
    Public contact
    Dr. Caren Sourij (Sub-Investigator), Medical University of Graz, 43 316385 78038, caren.sourij@medunigraz.at
    Scientific contact
    Prof. Harald Sourij, MBA (Principal Investigator), Medical University of Graz, 43 316385 81310, ha.sourij@medunigraz.at
    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
    30 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to investigate the short and mid-term humoral immune response to COVID-19 vaccines as assessed by anti-spike protein antibodies in people with diabetes as compared to healthy controls.
    Protection of trial subjects
    physical examination at the first visit assessment of general health status of each participant (e.g. general appearance, neck/thyroid, chest/lung., etc.) Systolic and diastolic blood pressure (mmHg), pulse (bpm), minimal invasive blood samples will be taken for laboratory safety variables (hematology, biochemistry coagulation, urinalysis)
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Apr 2021
    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
    Austria: 161
    Worldwide total number of subjects
    161
    EEA total number of subjects
    161
    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)
    146
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects will be recruited from the participant database kept at the trial site

    Pre-assignment
    Screening details
    Screening Visit: oral and written infos. After signing IC at the screening Visit participants will be screened for eligibility (inclusion/exclusion criteria), physical examination, Discussion of all procedures.

    Period 1
    Period 1 title
    Antibody response (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Antibody response
    Arm description
    Antibody response after vaccinations
    Arm type
    Active comparator

    Investigational medicinal product name
    Comirnaty/ Spykevax/ Vaxzevria
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    0.3 ml of the vaccine is injected into the deltoid muscle of the upper arm

    Number of subjects in period 1
    Antibody response
    Started
    161
    Completed
    150
    Not completed
    11
         Consent withdrawn by subject
    2
         postpone vaccination
    6
         subjects knowingly know having COVID-19
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Antibody response
    Reporting group description
    18 - 80 years

    Reporting group values
    Antibody response Total
    Number of subjects
    161 161
    Age categorical
    18 - 64 years
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    146 146
        From 65-84 years
    15 15
        85 years and over
    0 0
    Gender categorical
    Male and Female
    Units: Subjects
        Female
    71 71
        Male
    90 90

    End points

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    End points reporting groups
    Reporting group title
    Antibody response
    Reporting group description
    Antibody response after vaccinations

    Subject analysis set title
    T1D HbA1c ≤ 58 mmol/mol
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects with Type 1 Diabetes with a lower HbA1c under 58mmol/mol

    Subject analysis set title
    T1D HbA1c > 58 mmol/mol
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects wit Type 1 Diabetes with a higher HbA1c over 58 mmol/mol

    Subject analysis set title
    T2D HbA1c ≤ 58 mmol/mol
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects with Type 2 Diabetes with a lower HbA1c under 58 mmol/mol

    Subject analysis set title
    T2D HbA1c > 58 mmol/mol
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects with Type 2 Diabetes with a higher HbA1c over 58 mmol/mol

    Primary: CoV-2 S Antibody level

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    End point title
    CoV-2 S Antibody level
    End point description
    End point type
    Primary
    End point timeframe
    Level of antibodies At 7 to 14 days after the first vaccination
    End point values
    T1D HbA1c ≤ 58 mmol/mol T1D HbA1c > 58 mmol/mol T2D HbA1c ≤ 58 mmol/mol T2D HbA1c > 58 mmol/mol
    Number of subjects analysed
    49
    26
    37
    38
    Units: antibody unit(s)
        arithmetic mean (standard deviation)
    8696.0 ± 7095.8
    5822.2 ± 4144.5
    4204.6 ± 3961.7
    5804.1 ± 6522.9
    Statistical analysis title
    Antibody response
    Comparison groups
    T1D HbA1c ≤ 58 mmol/mol v T1D HbA1c > 58 mmol/mol v T2D HbA1c ≤ 58 mmol/mol v T2D HbA1c > 58 mmol/mol
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    < 0.05
    Method
    Chi-squared
    Parameter type
    Median difference (final values)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -
         upper limit
    -
    Notes
    [1] - Categorical variables were summarized as frequencies and percentages (%). Quantitative variables were summarized as means and standard deviations (±SD). Categorical variables were compared with diabetes groups using chi-squared or Fisher's exact tests, Postvaccination, side effects were compared between people with type 1 diabetes and type 2 diabetes using chi-squared or Fisher's exacts tests, multiple comparisons using post-hoc Bonferroni correction, or Wilcoxon's signed-rank test.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    16. April 2021 until 31. March 2023
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Temperature 37-37,9 °C
    Reporting group description
    -

    Reporting group title
    Temperature >38 °C
    Reporting group description
    -

    Reporting group title
    injection site reaction
    Reporting group description
    -

    Reporting group title
    Swelling
    Reporting group description
    -

    Reporting group title
    Redness
    Reporting group description
    -

    Reporting group title
    Pain
    Reporting group description
    -

    Reporting group title
    Headache
    Reporting group description
    -

    Reporting group title
    Fatigue
    Reporting group description
    -

    Reporting group title
    Arthralgia
    Reporting group description
    -

    Reporting group title
    Covid-19
    Reporting group description
    -

    Reporting group title
    Hepatocellular Carcinoma
    Reporting group description
    -

    Reporting group title
    Hypertensive crisis
    Reporting group description
    -

    Reporting group title
    Minor stroke
    Reporting group description
    -

    Reporting group title
    Dyspnea and oedema
    Reporting group description
    -

    Reporting group title
    AV Block III
    Reporting group description
    -

    Reporting group title
    Urteic stones
    Reporting group description
    -

    Reporting group title
    Syncope
    Reporting group description
    -

    Reporting group title
    Ovarian cyst
    Reporting group description
    -

    Reporting group title
    Chest pain (coronary heart disease)
    Reporting group description
    -

    Reporting group title
    Periradicular infiltration
    Reporting group description
    -

    Reporting group title
    Cerebellar infarction
    Reporting group description
    -

    Reporting group title
    NSTEMI
    Reporting group description
    -

    Reporting group title
    Sick sinus syndrome
    Reporting group description
    -

    Reporting group title
    Enteritis
    Reporting group description
    -

    Reporting group title
    Acute pancreatitis
    Reporting group description
    -

    Reporting group title
    Surgery (shoulder)
    Reporting group description
    -

    Reporting group title
    EPU/ablation
    Reporting group description
    -

    Reporting group title
    angina pectoris
    Reporting group description
    -

    Reporting group title
    Elective surgery
    Reporting group description
    -

    Serious adverse events
    Temperature 37-37,9 °C Temperature >38 °C injection site reaction Swelling Redness Pain Headache Fatigue Arthralgia Covid-19 Hepatocellular Carcinoma Hypertensive crisis Minor stroke Dyspnea and oedema AV Block III Urteic stones Syncope Ovarian cyst Chest pain (coronary heart disease) Periradicular infiltration Cerebellar infarction NSTEMI Sick sinus syndrome Enteritis Acute pancreatitis Surgery (shoulder) EPU/ablation angina pectoris Elective surgery
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    8 / 150 (5.33%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    2 / 150 (1.33%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    AV Block III
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain (coronary heart disease)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NSTEMI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sick sinus syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    EPU/ablation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    angina pectoris
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Periradikuläre Infiltration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgery (shoulder)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Elective surgery
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hypertensive crisis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    minor stroke
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar infarction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea and oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urteic stones
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Acute pancreatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    8 / 150 (5.33%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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: 3%
    Non-serious adverse events
    Temperature 37-37,9 °C Temperature >38 °C injection site reaction Swelling Redness Pain Headache Fatigue Arthralgia Covid-19 Hepatocellular Carcinoma Hypertensive crisis Minor stroke Dyspnea and oedema AV Block III Urteic stones Syncope Ovarian cyst Chest pain (coronary heart disease) Periradicular infiltration Cerebellar infarction NSTEMI Sick sinus syndrome Enteritis Acute pancreatitis Surgery (shoulder) EPU/ablation angina pectoris Elective surgery
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 150 (8.00%)
    2 / 150 (1.33%)
    104 / 150 (69.33%)
    16 / 150 (10.67%)
    9 / 150 (6.00%)
    98 / 150 (65.33%)
    33 / 150 (22.00%)
    45 / 150 (30.00%)
    15 / 150 (10.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    Investigations
    Injection site reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    104 / 150 (69.33%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    0
    0
    104
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Temperature 37 - 37,9
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 150 (8.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    12
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Temperature >38
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 150 (1.33%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Swelling
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    16 / 150 (10.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    0
    0
    0
    16
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Redness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    9 / 150 (6.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    0
    0
    0
    0
    9
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    98 / 150 (65.33%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    98
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    33 / 150 (22.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    33
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fatige
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    45 / 150 (30.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    45
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    15 / 150 (10.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    15
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/34984802
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