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    Clinical Trial Results:
    Effectiveness of low molecular weight heparin at increased doses prophylaxis weight-adjusted, compared with lower doses prophylaxis (intermediate or standard), on the onset of venous thromboembolism in coronavirus disease 2019 (COVID-19) hospitalized patients : The randomized multicentric controlled open-label trial COVI-DOSE

    Summary
    EudraCT number
    		 2020-001709-21
    Trial protocol
    		 FR  
    Global end of trial date
    03 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Oct 2023
    First version publication date
    22 Oct 2023
    Other versions
    Summary report(s)
    		 COVI-DOSE_Brief Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    2020PI073
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04373707
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHRU Nancy
    Sponsor organisation address
    Rue du MORVAN, Vandoeuvre les Nancy, France, 54511
    Public contact
    Direction de la Recherche Clinique , CHRU de Nancy, 33 383 155285, dripromoteur@chru-nancy.fr
    Scientific contact
    Direction de la Recherche Clinique , CHRU de Nancy, 33 383 155285, dripromoteur@chru-nancy.fr
    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
    11 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effectiveness, during the hospitalization, of low molecular weight heparin at increased doses prophylaxis weight-adjusted, compared with lower doses prophylaxis (intermediate or standard), on the onset of venous thromboembolism, causing death or not, in coronavirus 19 patients hospitalized in medical care units or intensive care units
    Protection of trial subjects
    Subjects included: Subjects able to express their consent and Subjects unable to express their consent and who are not under legal protection
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 The research involves comparing weight-adjusted prophylactic dose of low-molecular-weight heparin to fixed prophylactic dose
    Actual start date of recruitment
    13 May 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason, Regulatory reason, Scientific research
    Long term follow-up duration
    		 2 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 1000
    Worldwide total number of subjects
    1000
    EEA total number of subjects
    1000
    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)
    728
    From 65 to 84 years
    272
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of start: 11-May-2022 Date of last visit of last participated patient: 14-Sep-2021 Patients, with COVID-19, were enrolled in medical wards or intensive care units from 20 French hospitals.

    Pre-assignment
    Screening details
    		 Hospitalization for an acute respiratory COVID-19 infection SARS-Cov-2 infection diagnosed by biology (positive PCR for COVID-19 from any specimen and/or serology) and or by a composite criterium associating lung injury on imaging and clinical / biological symptoms suggestive of COVID-19 (eg : dyspnea, cough, fever, biological inflammatory syndrom

    Period 1
    Period 1 title
    Hospital stay maximal duration 28days
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental arm
    Arm description
    		 weight-adjusted inter- mediate dose of low-molecular-weight heparin
    Arm type
    		 Experimental

    Investigational medicinal product name
    low molecular-weight heparin
    Investigational medicinal product code
    Other name
    LOVENOX, INNOHEP, FRAGMINE, FRAXIPARINE
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Intravenous use
    Dosage and administration details
    patients received an increased weight-adjusted inter- mediate dose of low-molecular-weight heparin ranging from a double standard dose (e.g., enoxaparin 4000 UI twice daily for <50 kg) to a higher dose (e.g., enoxaparin 7000 UI twice daily for > 100 kg)

    Arm title
    		 Control arm
    Arm description
    		 fixed-dose of low-molecular-weight heparin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    low molecular-weight heparin
    Investigational medicinal product code
    Other name
    LOVENOX, INNOHEP, FRAGMINE, FRAXIPARINE
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Intravenous use
    Dosage and administration details
    patients admitted to the medical wards received a fixed standard dose of low-molecular-weight heparin (e.g., enoxaparin 4000 UI once daily), while patients from the intensive care units received a fixed doubled standard dose (e.g., enoxaparin 4000 UI twice daily)

    Number of subjects in period 1
    		Experimental arm Control arm
    Started
    502
    498
    28 days
    478
    471
    Completed
    478
    471
    Not completed
    24
    27
         Adverse event, serious fatal
    22
    25
         Consent withdrawn by subject
    2
    1
         other reason
    -
    1
    Period 2
    Period 2 title
    60 days after inclusion
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental arm
    Arm description
    		 weight-adjusted inter- mediate dose of low-molecular-weight heparin
    Arm type
    		 Experimental

    Investigational medicinal product name
    low molecular-weight heparin
    Investigational medicinal product code
    Other name
    LOVENOX, INNOHEP, FRAGMINE, FRAXIPARINE
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Intravenous use
    Dosage and administration details
    patients received an increased weight-adjusted inter- mediate dose of low-molecular-weight heparin ranging from a double standard dose (e.g., enoxaparin 4000 UI twice daily for <50 kg) to a higher dose (e.g., enoxaparin 7000 UI twice daily for > 100 kg)

    Arm title
    		 Control arm
    Arm description
    		 fixed-dose of low-molecular-weight heparin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    low molecular-weight heparin
    Investigational medicinal product code
    Other name
    LOVENOX, INNOHEP, FRAGMINE, FRAXIPARINE
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Intravenous use
    Dosage and administration details
    patients admitted to the medical wards received a fixed standard dose of low-molecular-weight heparin (e.g., enoxaparin 4000 UI once daily), while patients from the intensive care units received a fixed doubled standard dose (e.g., enoxaparin 4000 UI twice daily)

    Number of subjects in period 2
    		Experimental arm Control arm
    Started
    478
    471
    Completed
    449
    440
    Not completed
    29
    31
         Adverse event, serious fatal
    4
    6
         Consent withdrawn by subject
    1
    -
         other reasons
    4
    3
         Lost to follow-up
    20
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 weight-adjusted inter- mediate dose of low-molecular-weight heparin

    Reporting group title
    Control arm
    Reporting group description
    		 fixed-dose of low-molecular-weight heparin

    Reporting group values
    		 Experimental arm Control arm Total
    Number of subjects
    		 502 498 1000
    Age categorical
    Units: Subjects
        Less than 70 years
    		 368 360 728
        70 years or more
    		 134 138 272
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 62.2 (53.1 to 70.6) 61.8 (51.6 to 71.0) -
    Gender categorical
    Units: Subjects
        Female
    		 171 163 334
        Male
    		 331 335 666
    Body weight
    Units: Subjects
        Less than 50 kg
    		 9 8 17
        50-70 kg
    		 95 94 189
        70-100 kg
    		 308 317 625
        100 kg or more
    		 90 78 168
        Not available
    		 0 1 1
    Body mass index
    Units: Subjects
        Less than 30 kg/m²
    		 312 327 639
        30 kg/m² or more
    		 184 158 342
        Not available
    		 6 13 19
    Creatinine clearance (Cockcroft-Gault)
    Units: Subjects
        Less than 50 mL/min
    		 21 29 50
        50–90 mL/min
    		 149 160 309
        90 mL/min or more
    		 331 306 637
        Not available
    		 1 3 4
    Hospitalization in medical wards at inclusion
    Units: Subjects
        Yes
    		 407 394 801
        No
    		 95 104 199
    Hypertension
    Units: Subjects
        Yes
    		 195 204 399
        No
    		 297 291 588
        Not available
    		 10 3 13
    Diabetes mellitus
    Units: Subjects
        Yes
    		 112 104 216
        No
    		 379 391 770
        Not available
    		 11 3 14
    Hypercholesterolemia
    Units: Subjects
        Yes
    		 111 112 223
        No
    		 380 379 759
        Not available
    		 11 7 18
    Coronary heart disease
    Units: Subjects
        Yes
    		 45 33 78
        No
    		 450 461 911
        Not available
    		 7 4 11
    Sleep apnea
    Units: Subjects
        Yes
    		 44 41 85
        No
    		 450 451 901
        Not available
    		 8 6 14
    Chronic respiratory disease
    Units: Subjects
        Yes
    		 31 19 50
        No
    		 463 475 938
        Not available
    		 8 4 12
    Active cancer
    Units: Subjects
        Yes
    		 19 23 42
        No
    		 471 466 937
        Not available
    		 12 9 21
    History of venous thromboembolism
    Units: Subjects
        Yes
    		 19 26 45
        No
    		 476 468 944
        Not available
    		 7 4 11
    Stroke
    Units: Subjects
        Yes
    		 18 16 34
        No
    		 473 473 946
        Not available
    		 11 9 20
    Chronic kidney disease
    Units: Subjects
        Yes
    		 11 10 21
        No
    		 484 485 969
        Not available
    		 7 3 10
    Heart failure
    Units: Subjects
        Yes
    		 10 12 22
        No
    		 484 482 966
        Not available
    		 8 4 12
    Antiplatelet agent at baseline
    Units: Subjects
        Yes
    		 97 95 192
        No
    		 405 401 806
        Not available
    		 0 2 2
    Renin-angiotensin system blockers at baseline
    Units: Subjects
        Yes
    		 138 160 298
        No
    		 357 334 691
        Not available
    		 7 4 11
    Corticosteroid use at baseline (10 mg/day or more)
    Units: Subjects
        Yes
    		 57 48 105
        No
    		 436 447 883
        Not available
    		 9 3 12
    Dexamethasone
    COVID-19 specific treatments
    Units: Subjects
        Yes
    		 384 390 774
        No
    		 89 96 185
        Not available
    		 29 12 41
    Tocilizumab use
    COVID-19 specific treatments
    Units: Subjects
        Yes
    		 7 9 16
        No
    		 461 475 936
        Not available
    		 34 14 48
    Respiratory support
    Units: Subjects
        Supplemental oxygen ≤15 L/min
    		 404 401 805
        NI ventilation with high flow O2 support> 15 L/min
    		 14 19 33
        Invasive mechanical ventilation ± ECMO
    		 14 14 28
        No supplemental oxygen therapy
    		 62 57 119
        Not available
    		 8 7 15
    At least one dose of study drug
    Units: Subjects
        Yes
    		 481 485 966
        No
    		 21 13 34
    Full compliance
    Units: Subjects
        Yes
    		 436 437 873
        No
    		 45 48 93
        Not available
    		 21 13 34
    Body weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 83.0 (72.0 to 95.0) 81.7 (72.0 to 93.0) -
    Body mass index
    Units: kg/m²
        median (inter-quartile range (Q1-Q3))
    		 28.3 (24.9 to 32.2) 28.1 (24.8 to 31.3) -

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 weight-adjusted inter- mediate dose of low-molecular-weight heparin

    Reporting group title
    Control arm
    Reporting group description
    		 fixed-dose of low-molecular-weight heparin
    Reporting group title
    Experimental arm
    Reporting group description
    		 weight-adjusted inter- mediate dose of low-molecular-weight heparin

    Reporting group title
    Control arm
    Reporting group description
    		 fixed-dose of low-molecular-weight heparin

    Primary: Symptomatic venous thromboembolism

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    End point title
    		 Symptomatic venous thromboembolism
    End point description
    End point type
    Primary
    End point timeframe
    Hospital stay maximal duration 28days
    End point values
    		 Experimental arm Control arm
    Number of subjects analysed
    502
    498
    Units: subjects
        Yes
    6
    10
        No
    496
    488
    Attachments
    		 Cumulative Event Rates for the Primary Outcome
    Statistical analysis title
    		 Analysis of primary endpoint
    Comparison groups
    Experimental arm v Control arm
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Sub Hazard Ratio
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 1.63

    Secondary: Major bleeding or clinically relevant nonmajor bleeding

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    End point title
    		 Major bleeding or clinically relevant nonmajor bleeding
    End point description
    End point type
    Secondary
    End point timeframe
    Hospital stay maximal duration 28days
    End point values
    		 Experimental arm Control arm
    Number of subjects analysed
    502
    498
    Units: Subjects
        Yes
    29
    15
        No
    473
    483
    Statistical analysis title
    		 Analysis secondary outcome 2
    Comparison groups
    Experimental arm v Control arm
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Sub Hazard Ratio
    Point estimate
    1.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 3.63

    Secondary: Major bleeding

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    End point title
    		 Major bleeding
    End point description
    End point type
    Secondary
    End point timeframe
    Hospital stay maximal duration 28days
    End point values
    		 Experimental arm Control arm
    Number of subjects analysed
    502
    498
    Units: subjects
        Yes
    5
    6
        No
    497
    492
    Statistical analysis title
    		 Analysis secondary outcome 2
    Comparison groups
    Experimental arm v Control arm
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Sub Hazard Ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 2.7

    Secondary: Net clinical benefit

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    End point title
    		 Net clinical benefit
    End point description
    End point type
    Secondary
    End point timeframe
    Hospital stay maximal duration 28days
    End point values
    		 Experimental arm Control arm
    Number of subjects analysed
    502
    498
    Units: subjects
        Yes
    10
    16
        No
    492
    482
    Statistical analysis title
    		 Analysis secondary outcome 3
    Comparison groups
    Experimental arm v Control arm
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Sub Hazard Ratio
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 1.36

    Secondary: Net clinical benefit

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    End point title
    		 Net clinical benefit
    End point description
    End point type
    Secondary
    End point timeframe
    60 days after inclusion
    End point values
    		 Experimental arm Control arm
    Number of subjects analysed
    478
    471
    Units: subjects
        Yes
    15
    23
        No
    463
    448
    Statistical analysis title
    		 Analysis secondary outcome 4
    Comparison groups
    Control arm v Experimental arm
    Number of subjects included in analysis
    949
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Sub Hazard Ratio
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 1.23

    Secondary: Symptomatic venous thromboses of other sites

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    End point title
    		 Symptomatic venous thromboses of other sites
    End point description
    End point type
    Secondary
    End point timeframe
    Hospital stay maximal duration 28days
    End point values
    		 Experimental arm Control arm
    Number of subjects analysed
    502
    498
    Units: subjects
        Yes
    3
    3
        No
    499
    495
    Statistical analysis title
    		 Analysis secondary outcome 5
    Comparison groups
    Experimental arm v Control arm
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Sub Hazard Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 4.89

    Secondary: Symptomatic arterial thrombosis

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    End point title
    		 Symptomatic arterial thrombosis
    End point description
    End point type
    Secondary
    End point timeframe
    Hospital stay maximal duration 28days
    End point values
    		 Experimental arm Control arm
    Number of subjects analysed
    502
    498
    Units: subjects
        Yes
    1
    2
        No
    501
    496
    Statistical analysis title
    		 Analysis secondary outcome 6
    Comparison groups
    Experimental arm v Control arm
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Sub Hazard Ratio
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 5.41

    Secondary: All-cause death

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    End point title
    		 All-cause death
    End point description
    End point type
    Secondary
    End point timeframe
    Hospital stay maximal duration 28days
    End point values
    		 Experimental arm Control arm
    Number of subjects analysed
    502
    498
    Units: subjects
        Yes
    22
    25
        No
    480
    473
    Statistical analysis title
    		 Analysis secondary outcome 7
    Comparison groups
    Experimental arm v Control arm
    Number of subjects included in analysis
    1000
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.55

    Secondary: All-cause death

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    End point title
    		 All-cause death
    End point description
    End point type
    Secondary
    End point timeframe
    60 days after inclusion
    End point values
    		 Experimental arm Control arm
    Number of subjects analysed
    478
    471
    Units: subjects
        Yes
    26
    31
        No
    452
    440
    Statistical analysis title
    		 Analysis secondary outcome 8
    Comparison groups
    Experimental arm v Control arm
    Number of subjects included in analysis
    949
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAE were collected and transmitted without undue delay to the sponsor from the enrollment until the end of the study. AE were collected in the CRF throughout the patient's participation in the study (for 1 month or until discharge whichever is shorter).
    Adverse event reporting additional description
    Patients were monitored using the usual patient management parameters COVID-19 during routine inpatient care (medical or intensive care) at the investigator's discretion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 Adjusted posology

    Reporting group title
    Control arm
    Reporting group description
    		 Non adjusted posology

    Serious adverse events
    		 Experimental arm Control arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    162 / 502 (32.27%)
    147 / 498 (29.52%)
         number of deaths (all causes)
    53
    58
         number of deaths resulting from adverse events
    27
    31
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic neoplasm
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Naevus haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arterial thrombosis
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 502 (0.20%)
    4 / 498 (0.80%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    2 / 502 (0.40%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 502 (0.00%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    5 / 502 (1.00%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery dissection
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 502 (0.20%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral coldness
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superficial vein thrombosis
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    3 / 502 (0.60%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac pacemaker insertion
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileectomy
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung assist device therapy
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palliative care
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheostomy
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concomitant disease aggravated
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Condition aggravated
         subjects affected / exposed
    0 / 502 (0.00%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site haematoma
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site haemorrhage
         subjects affected / exposed
    3 / 502 (0.60%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    7 / 502 (1.39%)
    6 / 498 (1.20%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 7
         deaths causally related to treatment / all
    0 / 7
    1 / 7
    No adverse event
         subjects affected / exposed
    21 / 502 (4.18%)
    20 / 498 (4.02%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Immunosuppression
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Intermenstrual bleeding
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    3 / 502 (0.60%)
    7 / 498 (1.41%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Acute respiratory failure
         subjects affected / exposed
    2 / 502 (0.40%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Bronchial haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    7 / 502 (1.39%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    6 / 7
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    3 / 502 (0.60%)
    4 / 498 (0.80%)
         occurrences causally related to treatment / all
    3 / 3
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Haemothorax
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    3 / 502 (0.60%)
    5 / 498 (1.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Interstitial lung disease
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pharyngeal haemorrhage
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    7 / 502 (1.39%)
    10 / 498 (2.01%)
         occurrences causally related to treatment / all
    0 / 7
    2 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary infarction
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory distress
         subjects affected / exposed
    2 / 502 (0.40%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 502 (0.60%)
    4 / 498 (0.80%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Respiratory tract haemorrhage
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Computerised tomogram normal
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Red blood cell count decreased
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ultrasound Doppler normal
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    10 / 502 (1.99%)
    7 / 498 (1.41%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Dose calculation error
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endotracheal intubation complication
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eschar
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product administration error
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product prescribing error
         subjects affected / exposed
    33 / 502 (6.57%)
    28 / 498 (5.62%)
         occurrences causally related to treatment / all
    1 / 36
    1 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal haemorrhage
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasoplegia syndrome
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haematoma
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arrhythmia
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 502 (0.60%)
    5 / 498 (1.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 502 (0.40%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac failure
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac flutter
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardio-respiratory arrest
         subjects affected / exposed
    6 / 502 (1.20%)
    4 / 498 (0.80%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 6
    0 / 4
    Myocardial ischaemia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular hypokinesia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (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
    Cerebellar stroke
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhagic transformation stroke
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningorrhagia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    9 / 502 (1.79%)
    11 / 498 (2.21%)
         occurrences causally related to treatment / all
    5 / 9
    8 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Papilloedema
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    3 / 502 (0.60%)
    4 / 498 (0.80%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    2 / 502 (0.40%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    5 / 502 (1.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    4 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cytolysis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Bullous haemorrhagic dermatosis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Purpura
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous emphysema
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    4 / 502 (0.80%)
    4 / 498 (0.80%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Haematuria
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    3 / 502 (0.60%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haematoma muscle
         subjects affected / exposed
    5 / 502 (1.00%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Cellulitis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    7 / 502 (1.39%)
    8 / 498 (1.61%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 6
    0 / 8
    COVID-19 pneumonia
         subjects affected / exposed
    3 / 502 (0.60%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peritonitis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii infection
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 502 (0.20%)
    6 / 498 (1.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Severe acute respiratory syndrome
         subjects affected / exposed
    1 / 502 (0.20%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 3
    Superinfection bacterial
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombophlebitis septic
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Veillonella infection
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    2 / 502 (0.40%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Experimental arm Control arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    225 / 502 (44.82%)
    325 / 498 (65.26%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic neoplasm
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Monoclonal gammopathy
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Basal cell carcinoma
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Adrenal neoplasm
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Renal neoplasm
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Haemorrhage
    Additional description: minor haemorrhage
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Haematoma
         subjects affected / exposed
    1 / 502 (0.20%)
    5 / 498 (1.00%)
         occurrences all number
    1
    6
    Hypertension
         subjects affected / exposed
    3 / 502 (0.60%)
    1 / 498 (0.20%)
         occurrences all number
    3
    1
    Hypotension
         subjects affected / exposed
    2 / 502 (0.40%)
    3 / 498 (0.60%)
         occurrences all number
    2
    3
    Thrombosis
    Additional description: blood clots
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Vascular pain
    Additional description: vein inflammation (veinitis)
         subjects affected / exposed
    3 / 502 (0.60%)
    5 / 498 (1.00%)
         occurrences all number
    3
    5
    Venous thrombosis
    Additional description: distal venous thrombosis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Gastrostomy
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Tracheostomy
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Disease progression
         subjects affected / exposed
    1 / 502 (0.20%)
    4 / 498 (0.80%)
         occurrences all number
    1
    4
    Generalised oedema
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Hyperthermia
         subjects affected / exposed
    3 / 502 (0.60%)
    2 / 498 (0.40%)
         occurrences all number
    3
    5
    Hypothermia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Inflammation
    Additional description: biological inflammatory syndrome
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Injection site erythema
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Injection site inflammation
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Injection site pain
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences all number
    0
    2
    Oedema
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    6 / 502 (1.20%)
    11 / 498 (2.21%)
         occurrences all number
    7
    11
    Physical deconditioning
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Puncture site haematoma
         subjects affected / exposed
    2 / 502 (0.40%)
    1 / 498 (0.20%)
         occurrences all number
    2
    1
    Puncture site haemorrhage
         subjects affected / exposed
    5 / 502 (1.00%)
    3 / 498 (0.60%)
         occurrences all number
    6
    4
    Pyrexia
         subjects affected / exposed
    2 / 502 (0.40%)
    1 / 498 (0.20%)
         occurrences all number
    3
    1
    Ulcer
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Social circumstances
    Loss of personal independence in daily activities
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Penile dermatitis
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Acute respiratory failure
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Atelectasis
         subjects affected / exposed
    4 / 502 (0.80%)
    1 / 498 (0.20%)
         occurrences all number
    4
    1
    Bronchitis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    2
    2
    Cough
         subjects affected / exposed
    2 / 502 (0.40%)
    1 / 498 (0.20%)
         occurrences all number
    2
    1
    Dysphonia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    2 / 502 (0.40%)
    2 / 498 (0.40%)
         occurrences all number
    2
    2
    Dyspnoea exertional
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    13 / 502 (2.59%)
    13 / 498 (2.61%)
         occurrences all number
    15
    13
    Haemoptysis
         subjects affected / exposed
    6 / 502 (1.20%)
    9 / 498 (1.81%)
         occurrences all number
    6
    9
    Hypercapnia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Hypoxia
         subjects affected / exposed
    3 / 502 (0.60%)
    7 / 498 (1.41%)
         occurrences all number
    3
    7
    Laryngeal oedema
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Oropharyngeal oedema
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Pneumomediastinum
         subjects affected / exposed
    2 / 502 (0.40%)
    2 / 498 (0.40%)
         occurrences all number
    2
    2
    Pneumothorax
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Tachypnoea
         subjects affected / exposed
    2 / 502 (0.40%)
    1 / 498 (0.20%)
         occurrences all number
    2
    2
    Pulmonary embolism
    Additional description: suspected but not confirmed pulmonary embolism
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Pulmonary mass
    Additional description: nodules
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Respiratory acidosis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Respiratory alkalosis
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences all number
    2
    0
    Respiratory disorder
    Additional description: respiratory worsening
         subjects affected / exposed
    29 / 502 (5.78%)
    26 / 498 (5.22%)
         occurrences all number
    30
    26
    Respiratory distress
         subjects affected / exposed
    2 / 502 (0.40%)
    4 / 498 (0.80%)
         occurrences all number
    2
    4
    Respiratory failure
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Tracheal haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Tracheomalacia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences all number
    0
    2
    Agitation
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    6 / 502 (1.20%)
    3 / 498 (0.60%)
         occurrences all number
    6
    3
    Brief psychotic disorder without marked stressors
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Confusional state
         subjects affected / exposed
    2 / 502 (0.40%)
    2 / 498 (0.40%)
         occurrences all number
    2
    2
    Insomnia
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Sleep disorder
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Antiphospholipid antibodies
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Bacterial test positive
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Blood urea increased
         subjects affected / exposed
    2 / 502 (0.40%)
    2 / 498 (0.40%)
         occurrences all number
    2
    2
    Bronchoscopy abnormal
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 502 (0.40%)
    3 / 498 (0.60%)
         occurrences all number
    2
    3
    Sputum culture positive
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Injury, poisoning and procedural complications
    Weaning failure
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Ear injury
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Eschar
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Fall
         subjects affected / exposed
    0 / 502 (0.00%)
    4 / 498 (0.80%)
         occurrences all number
    0
    3
    Tooth fracture
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    6 / 502 (1.20%)
    4 / 498 (0.80%)
         occurrences all number
    6
    5
    Bradycardia
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Cardiac murmur
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Heart transplant rejection
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Myocarditis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    2 / 502 (0.40%)
    2 / 498 (0.40%)
         occurrences all number
    2
    2
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Ventricular tachycardia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Aphasia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Burning sensation
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Gait disturbance
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Hemiparesis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Loss of consciousness
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences all number
    2
    0
    Paraesthesia
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Polyneuropathy
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Presyncope
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 502 (0.80%)
    6 / 498 (1.20%)
         occurrences all number
    4
    7
    Hyperleukocytosis
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Leukocytosis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Lymphopenia
         subjects affected / exposed
    3 / 502 (0.60%)
    3 / 498 (0.60%)
         occurrences all number
    3
    3
    Microcytic anaemia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Neutrophilia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Splenomegaly
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    3 / 502 (0.60%)
    2 / 498 (0.40%)
         occurrences all number
    3
    3
    Thrombocytosis
         subjects affected / exposed
    6 / 502 (1.20%)
    4 / 498 (0.80%)
         occurrences all number
    6
    4
    Eye disorders
    blepharitis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Eye oedema
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Cheilitis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Colitis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    2 / 502 (0.40%)
    3 / 498 (0.60%)
         occurrences all number
    2
    3
    Diarrhoea
         subjects affected / exposed
    2 / 502 (0.40%)
    7 / 498 (1.41%)
         occurrences all number
    2
    7
    Dry mouth
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Dysphagia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Enteritis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Faecaloma
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Gastric ulcer
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Lip haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Lip ulceration
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Macroglossia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Mouth haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Regurgitation
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Stomatitis haemorrhagic
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences all number
    0
    2
    Subileus
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Cholecystitis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Cholestasis
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences all number
    2
    0
    Hepatic cytolysis
         subjects affected / exposed
    22 / 502 (4.38%)
    10 / 498 (2.01%)
         occurrences all number
    22
    10
    Hepatitis viral
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Hypertransaminasaemia
         subjects affected / exposed
    3 / 502 (0.60%)
    6 / 498 (1.20%)
         occurrences all number
    3
    7
    Liver disorder
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    alopecia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Blister
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    2 / 502 (0.40%)
    1 / 498 (0.20%)
         occurrences all number
    2
    1
    Ecchymosis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Erythema
         subjects affected / exposed
    2 / 502 (0.40%)
    2 / 498 (0.40%)
         occurrences all number
    2
    2
    Rash
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Livedo reticularis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Rash macular
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    1 / 502 (0.20%)
    3 / 498 (0.60%)
         occurrences all number
    1
    3
    Skin lesion
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Subcutaneous emphysema
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Urticaria
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Skin erosion
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 502 (1.00%)
    7 / 498 (1.41%)
         occurrences all number
    5
    7
    Cystitis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Dysuria
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    End stage renal disease
         subjects affected / exposed
    2 / 502 (0.40%)
    1 / 498 (0.20%)
         occurrences all number
    2
    1
    Haematuria
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences all number
    2
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Oliguria
         subjects affected / exposed
    0 / 502 (0.00%)
    3 / 498 (0.60%)
         occurrences all number
    0
    3
    Polyuria
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Renal failure
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences all number
    0
    2
    Urethral haemorrhage
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Urinary retention
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 502 (0.00%)
    3 / 498 (0.60%)
         occurrences all number
    0
    3
    Back pain
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 502 (0.20%)
    2 / 498 (0.40%)
         occurrences all number
    1
    2
    Pelvic misalignment
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Sarcopenia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Tendonitis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Aspergillus infection
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Bacteraemia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    2
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Candida infection
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Genital herpes
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    HIV infection
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    4 / 502 (0.80%)
    1 / 498 (0.20%)
         occurrences all number
    4
    1
    peritonitis
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Pneumococcal infection
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Pneumonia bacterial
         subjects affected / exposed
    8 / 502 (1.59%)
    7 / 498 (1.41%)
         occurrences all number
    11
    9
    Pneumonitis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Pyelonephritis
         subjects affected / exposed
    2 / 502 (0.40%)
    3 / 498 (0.60%)
         occurrences all number
    2
    3
    Sepsis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Septic shock
         subjects affected / exposed
    0 / 502 (0.00%)
    2 / 498 (0.40%)
         occurrences all number
    0
    2
    Sinusitis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Superinfection
         subjects affected / exposed
    3 / 502 (0.60%)
    5 / 498 (1.00%)
         occurrences all number
    3
    5
    Tooth abscess
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    4 / 502 (0.80%)
    4 / 498 (0.80%)
         occurrences all number
    4
    4
    Blood creatine phosphokinase BB increased
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Blood culture positive
         subjects affected / exposed
    0 / 502 (0.00%)
    3 / 498 (0.60%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    8 / 502 (1.59%)
    8 / 498 (1.61%)
         occurrences all number
    8
    8
    Diabetes mellitus inadequate control
         subjects affected / exposed
    3 / 502 (0.60%)
    3 / 498 (0.60%)
         occurrences all number
    3
    3
    Hypercalcaemia
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    7 / 502 (1.39%)
    7 / 498 (1.41%)
         occurrences all number
    8
    9
    Hypernatraemia
         subjects affected / exposed
    3 / 502 (0.60%)
    2 / 498 (0.40%)
         occurrences all number
    3
    2
    Hyperthyroidism
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 498 (0.20%)
         occurrences all number
    1
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 502 (0.20%)
    3 / 498 (0.60%)
         occurrences all number
    1
    3
    Hypocalcaemia
         subjects affected / exposed
    1 / 502 (0.20%)
    3 / 498 (0.60%)
         occurrences all number
    1
    4
    Hypoglycaemia
         subjects affected / exposed
    2 / 502 (0.40%)
    0 / 498 (0.00%)
         occurrences all number
    2
    0
    Hypokalaemia
         subjects affected / exposed
    9 / 502 (1.79%)
    4 / 498 (0.80%)
         occurrences all number
    9
    4
    Hyponatraemia
         subjects affected / exposed
    4 / 502 (0.80%)
    7 / 498 (1.41%)
         occurrences all number
    4
    7
    Hypophosphataemia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Hypovitaminosis
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 498 (0.00%)
         occurrences all number
    1
    0
    Malnutrition
         subjects affected / exposed
    3 / 502 (0.60%)
    5 / 498 (1.00%)
         occurrences all number
    3
    5
    Type 2 diabetes mellitus
         subjects affected / exposed
    3 / 502 (0.60%)
    0 / 498 (0.00%)
         occurrences all number
    3
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 498 (0.20%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2020
    MS1: New participating centres
    03 Jul 2020
    MS2: New participating centres
    06 Aug 2020
    MS3: clarification of inclusion criteria + increase in inclusion duration
    20 Nov 2020
    MS4: New participating centres
    14 Jan 2021
    MS5: New participating centres
    15 Feb 2021
    MS6: New participating centres
    15 Feb 2021
    MS7: Increase in the number of subjects required from 602 to 1000 subjects.
    02 Jun 2021
    MS8: Modification of non-inclusion criteria

    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/37350990
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