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    Clinical Trial Results:
    A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults

    Summary
    EudraCT number
    2020-005315-44
    Trial protocol
    DE   IT   HU   PL   BG  
    Global end of trial date
    19 Oct 2022

    Results information
    Results version number
    v1
    This version publication date
    02 Jun 2023
    First version publication date
    02 Jun 2023
    Other versions
    v2

    Trial information

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    Trial identification
    Sponsor protocol code
    D8851C00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04723394
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    S-151, Sodertalje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca, 1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, 1 8772409479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the efficacy of AZD7442 in the prevention of the composite endpoint of either severe COVID-19 or death from any cause through study Day 29
    Protection of trial subjects
    This study is conducted in accordance with the protocol and with the following: Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines; Applicable International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) Guidelines; Applicable laws and regulations. The protocol, protocol amendments, Informed Consent Form (ICF), Investigator Brochure, and other relevant documents (e.g. advertisements) must be submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC) by the Investigator and reviewed and approved by the IRB/IEC before the study is initiated. Any amendments to the protocol will require IRB/IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study patients. Where applicable as per relevant laws and regulations, amendments will also be submitted to, reviewed and approved by regulatory authorities/national competent authorities.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 60
    Country: Number of subjects enrolled
    Brazil: 27
    Country: Number of subjects enrolled
    Czechia: 7
    Country: Number of subjects enrolled
    Germany: 92
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 73
    Country: Number of subjects enrolled
    Japan: 42
    Country: Number of subjects enrolled
    Mexico: 310
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Russian Federation: 119
    Country: Number of subjects enrolled
    Spain: 70
    Country: Number of subjects enrolled
    Ukraine: 16
    Country: Number of subjects enrolled
    United Kingdom: 44
    Country: Number of subjects enrolled
    United States: 149
    Worldwide total number of subjects
    1014
    EEA total number of subjects
    247
    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)
    890
    From 65 to 84 years
    123
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    910 participants were randomized to receive treatment in study D8851C00001 (TACKLE) with AZD7442 (AZD8895 + AZD1061) or placebo. Of the 910 participants randomized, 903 (99.2%) received treatment with study drug. Of the 903 dosed, 452 (50.1%) participants received AZD7442 and 451 (49.9%) participants received placebo.

    Pre-assignment
    Screening details
    In TACKLE, at the first visit, ie, the enrollment visit 1, participants were evaluated regarding the protocol mandated inclusion and exclusion criteria. After enrolment, eligible participants were randomized at a 1: 1 ratio to receive a single dose of study provided AZD7442 (AZD8895 + AZD1061) or placebo.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    AZD7442
    Arm description
    Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1
    Arm type
    Experimental

    Investigational medicinal product name
    Combination of 2 mAbs (AZD8895 and AZD1061)
    Investigational medicinal product code
    Other name
    tixagevimab–cilgavimab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose (× 2 separate IM injections) of 600 mg of AZD7442 on Day 1.

    Arm title
    Placebo
    Arm description
    Single dose of Placebo (2 separate IM injections) on Day 1
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose (× 2 separate IM injections) of saline placebo on Day 1.

    Number of subjects in period 1 [1]
    AZD7442 Placebo
    Started
    452
    451
    Modified Full Analysis Set
    413
    421
    Primary Analysis Population
    410
    419
    Key Secondary Analysis Population
    404 [2]
    411
    Completed
    407
    390
    Not completed
    45
    61
         Adverse event, serious fatal
    8
    8
         Consent withdrawn by subject
    17
    33
         Adverse event, non-fatal
    -
    3
         Lost to follow-up
    20
    17
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1014 total participants enrolled in the study but only 903 dosed, and we report results of these dosed participants (Full Analysis Set).
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: These participants are those who have non-missing results of key secondary endpoint.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD7442
    Reporting group description
    Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1

    Reporting group title
    Placebo
    Reporting group description
    Single dose of Placebo (2 separate IM injections) on Day 1

    Reporting group values
    AZD7442 Placebo Total
    Number of subjects
    452 451 903
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    393 394 787
        From 65-84 years
    59 56 115
        85 years and over
    0 1 1
    Age Continuous
    Full Analysis Set
    Units: years
        median (full range (min-max))
    46.0 (18.0 to 83.0) 46.0 (18.0 to 86.0) -
    Sex: Female, Male
    Units: Participants
        Female
    239 216 455
        Male
    213 235 448
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    230 238 468
        Not Hispanic or Latino
    222 213 435
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    100 115 215
        Asian
    30 21 51
        Black or African American
    16 20 36
        Multiple
    0 0 0
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Not reported
    21 21 42
        White
    285 274 559
    Risk of Progression to Severe COVID-19
    Risk of Progression to Severe COVID-19 is assessed based on participant's medical history - based on FDA/CDC guidelines. Summarized in the Full Analysis Set
    Units: Subjects
        High
    405 406 811
        Low
    47 45 92
    Country
    Units: Subjects
        Argentina
    29 28 57
        Brazil
    7 12 19
        Czech Republic
    3 2 5
        Germany
    33 38 71
        Hungary
    2 1 3
        Italy
    37 33 70
        Japan
    26 14 40
        Mexico
    139 166 305
        Poland
    1 1 2
        Russian Federation
    55 51 106
        Spain
    31 37 68
        Ukraine
    5 10 15
        United Kingdom
    20 18 38
        United States
    64 40 104
    Age Continuous
    Full Analysis Set
    Units: Years
        arithmetic mean (standard deviation)
    46.3 ( 15.42 ) 45.9 ( 14.99 ) -
    BMI (kg/m^2)
    Full Analysis Set
    Units: kg/m^2
        arithmetic mean (standard deviation)
    28.9 ( 5.46 ) 29.2 ( 6.56 ) -
    Subject analysis sets

    Subject analysis set title
    AZD7442 modified Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All participants in the full analysis set who received AZD7442 ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose.

    Subject analysis set title
    Placebo modified Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All participants in the full analysis set who received placebo ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose.

    Subject analysis sets values
    AZD7442 modified Full Analysis Set Placebo modified Full Analysis Set
    Number of subjects
    413
    421
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Full Analysis Set
    Units: years
        median (full range (min-max))
    Sex: Female, Male
    Units: Participants
        Female
    226
    206
        Male
    187
    215
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
        Asian
        Black or African American
        Multiple
        Native Hawaiian or Other Pacific Islander
        Not reported
        White
    Risk of Progression to Severe COVID-19
    Risk of Progression to Severe COVID-19 is assessed based on participant's medical history - based on FDA/CDC guidelines. Summarized in the Full Analysis Set
    Units: Subjects
        High
        Low
    Country
    Units: Subjects
        Argentina
        Brazil
        Czech Republic
        Germany
        Hungary
        Italy
        Japan
        Mexico
        Poland
        Russian Federation
        Spain
        Ukraine
        United Kingdom
        United States
    Age Continuous
    Full Analysis Set
    Units: Years
        arithmetic mean (standard deviation)
    ( )
    ( )
    BMI (kg/m^2)
    Full Analysis Set
    Units: kg/m^2
        arithmetic mean (standard deviation)
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    AZD7442
    Reporting group description
    Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1

    Reporting group title
    Placebo
    Reporting group description
    Single dose of Placebo (2 separate IM injections) on Day 1

    Subject analysis set title
    AZD7442 modified Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All participants in the full analysis set who received AZD7442 ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose.

    Subject analysis set title
    Placebo modified Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All participants in the full analysis set who received placebo ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose.

    Primary: A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29

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    End point title
    A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29
    End point description
    Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, and lung infiltrates) or hypoxemia (SpO2 < 90% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Day 29
    End point values
    AZD7442 modified Full Analysis Set Placebo modified Full Analysis Set
    Number of subjects analysed
    410
    419
    Units: Participants
    18
    37
    Statistical analysis title
    relative risk reduction
    Statistical analysis description
    AZD7442 vs Placebo
    Comparison groups
    AZD7442 modified Full Analysis Set v Placebo modified Full Analysis Set
    Number of subjects included in analysis
    829
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.01
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Relative Risk Reduction (100*[1-RR])
    Point estimate
    50.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.38
         upper limit
    71.25
    Notes
    [1] - The relative risk reduction RRR represents the percent reduction in incidence of severe COVID-19 or death from any cause in the AZD7442 group relative to placebo. A RRR > 0 represents favorable efficacy in the AZD7442 group. A p-value <0.05 indicates a statistically significant result.

    Secondary: A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169

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    End point title
    A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169
    End point description
    Death from Any Cause or Hospitalization for COVID-19 Complications or Sequelae through Day 169
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Day 169
    End point values
    AZD7442 modified Full Analysis Set Placebo modified Full Analysis Set
    Number of subjects analysed
    404
    411
    Units: Participants
    20
    40
    Statistical analysis title
    relative risk reduction
    Statistical analysis description
    AZD7442 vs Placebo
    Comparison groups
    AZD7442 modified Full Analysis Set v Placebo modified Full Analysis Set
    Number of subjects included in analysis
    815
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    = 0.009
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Relative Risk Reduction (100*[1-RR])
    Point estimate
    49.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.72
         upper limit
    69.79
    Notes
    [2] - The relative risk reduction RRR represents the percent reduction in incidence of death from any cause or hospitalization for COVID-19 complications or sequelae in the AZD7442 group relative to placebo. A RRR > 0 represents favorable efficacy in the AZD7442 group. A p-value <0.05 indicates a statistically significant result. Participants who discontinued or were lost to follow up prior to Day 169 are considered missing.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until end of study, with an average of 436 days.
    Adverse event reporting additional description
    AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Description (Arm-group)

    Reporting group title
    AZD7442 600 mg
    Reporting group description
    Description (Arm-group)

    Serious adverse events
    Placebo AZD7442 600 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    65 / 451 (14.41%)
    46 / 452 (10.18%)
         number of deaths (all causes)
    8
    8
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colorectal cancer metastatic
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden cardiac death
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Death
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Acute left ventricular failure
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute coronary syndrome
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior sagittal sinus thrombosis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia of malignant disease
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood loss anaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immobilisation syndrome
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection bacterial
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    37 / 451 (8.20%)
    23 / 452 (5.09%)
         occurrences causally related to treatment / all
    0 / 37
    0 / 23
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    COVID-19
         subjects affected / exposed
    9 / 451 (2.00%)
    2 / 452 (0.44%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Appendicitis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial diarrhoea
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo AZD7442 600 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    224 / 451 (49.67%)
    230 / 452 (50.88%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma cell myeloma
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Bladder cancer
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Skin papilloma
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Acrochordon
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Anogenital warts
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Essential hypertension
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Brachiocephalic arteriosclerosis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Deep vein thrombosis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    18 / 451 (3.99%)
    16 / 452 (3.54%)
         occurrences all number
    18
    16
    Hypertensive crisis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Hypertensive urgency
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Lymphostasis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Peripheral artery aneurysm
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Thrombophlebitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Abdominal wall operation
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    9 / 451 (2.00%)
    8 / 452 (1.77%)
         occurrences all number
    9
    10
    Injection site swelling
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    2
    Chest discomfort
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Decreased activity
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Energy increased
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Face oedema
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    15 / 451 (3.33%)
    16 / 452 (3.54%)
         occurrences all number
    17
    16
    Feeling hot
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Gait disturbance
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Injection site bruising
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Injection site erythema
         subjects affected / exposed
    2 / 451 (0.44%)
    2 / 452 (0.44%)
         occurrences all number
    2
    2
    Injection site haematoma
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Injection site induration
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Injection site inflammation
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Injection site nodule
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    2
    Injection site pain
         subjects affected / exposed
    11 / 451 (2.44%)
    8 / 452 (1.77%)
         occurrences all number
    15
    12
    Injection site warmth
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Pain
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 451 (0.00%)
    3 / 452 (0.66%)
         occurrences all number
    0
    4
    Suprapubic pain
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Vaccination site pain
         subjects affected / exposed
    2 / 451 (0.44%)
    3 / 452 (0.66%)
         occurrences all number
    3
    6
    Vaccination site reaction
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Adverse drug reaction
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Application site haematoma
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Injection site discomfort
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    3
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Oedema peripheral
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Drug hypersensitivity
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Social circumstances
    Unhealthy diet
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Hypomenorrhoea
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Erectile dysfunction
         subjects affected / exposed
    4 / 451 (0.89%)
    0 / 452 (0.00%)
         occurrences all number
    4
    0
    Menstruation irregular
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Nipple pain
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Ovarian cyst
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Polycystic ovaries
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Prostatitis
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Prostatomegaly
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Vulvovaginal erythema
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Bartholin's cyst
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Breast discharge
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Endometrial thickening
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Menopausal symptoms
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 451 (0.44%)
    2 / 452 (0.44%)
         occurrences all number
    2
    2
    Bronchitis chronic
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Bronchospasm
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Cough
         subjects affected / exposed
    4 / 451 (0.89%)
    8 / 452 (1.77%)
         occurrences all number
    4
    8
    Dyspnoea
         subjects affected / exposed
    11 / 451 (2.44%)
    3 / 452 (0.66%)
         occurrences all number
    12
    3
    Dyspnoea exertional
         subjects affected / exposed
    3 / 451 (0.67%)
    4 / 452 (0.88%)
         occurrences all number
    3
    5
    Epistaxis
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    4
    0
    Hiccups
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Interstitial lung disease
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    2
    Nasal congestion
         subjects affected / exposed
    3 / 451 (0.67%)
    1 / 452 (0.22%)
         occurrences all number
    3
    1
    Nasal obstruction
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Organising pneumonia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 451 (0.67%)
    0 / 452 (0.00%)
         occurrences all number
    4
    0
    Pleurisy
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Rales
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Respiratory failure
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    3 / 451 (0.67%)
    1 / 452 (0.22%)
         occurrences all number
    3
    1
    Rhinorrhoea
         subjects affected / exposed
    4 / 451 (0.89%)
    0 / 452 (0.00%)
         occurrences all number
    5
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Vocal cord polyp
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Acute stress disorder
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Alcohol abuse
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Alcoholism
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    4 / 451 (0.89%)
    3 / 452 (0.66%)
         occurrences all number
    4
    3
    Anxiety disorder
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Bruxism
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Burnout syndrome
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Confusional state
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Depression
         subjects affected / exposed
    5 / 451 (1.11%)
    5 / 452 (1.11%)
         occurrences all number
    5
    5
    Insomnia
         subjects affected / exposed
    2 / 451 (0.44%)
    7 / 452 (1.55%)
         occurrences all number
    2
    7
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Stress
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Cholecystitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Cholelithiasis
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    Cholestasis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hepatic failure
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Hepatic steatosis
         subjects affected / exposed
    2 / 451 (0.44%)
    2 / 452 (0.44%)
         occurrences all number
    2
    2
    Hepatitis toxic
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Investigations
    Blood urine present
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Body temperature increased
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    Cardiac murmur
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Hepatitis A antibody
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Lipids abnormal
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Oxygen saturation decreased
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Platelet count increased
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Complications of transplanted kidney
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Incision site haemorrhage
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Joint injury
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Ligament injury
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    5 / 451 (1.11%)
    1 / 452 (0.22%)
         occurrences all number
    5
    1
    Limb injury
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Meniscus injury
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Muscle injury
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Post procedural swelling
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Post-traumatic pain
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Procedural haemorrhage
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Road traffic accident
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Thermal burn
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Vaccination complication
         subjects affected / exposed
    13 / 451 (2.88%)
    13 / 452 (2.88%)
         occurrences all number
    33
    29
    Ankle fracture
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Azygos lobe
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Atrial fibrillation
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Bradycardia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure acute
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Cardiac failure chronic
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Coronary artery disease
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Mitral valve disease
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Nodal rhythm
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    2 / 451 (0.44%)
    3 / 452 (0.66%)
         occurrences all number
    2
    3
    Sinus arrhythmia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Cardiac flutter
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    2 / 451 (0.44%)
    2 / 452 (0.44%)
         occurrences all number
    2
    2
    Amnesia
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Anosmia
         subjects affected / exposed
    3 / 451 (0.67%)
    8 / 452 (1.77%)
         occurrences all number
    3
    9
    Apallic syndrome
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Aphasia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Cerebral arteriosclerosis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Cerebral hypoperfusion
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Disturbance in attention
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Dizziness
         subjects affected / exposed
    1 / 451 (0.22%)
    8 / 452 (1.77%)
         occurrences all number
    1
    8
    Dysaesthesia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Encephalopathy
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Facial paralysis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Head discomfort
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    11 / 451 (2.44%)
    13 / 452 (2.88%)
         occurrences all number
    15
    14
    Hemiparaesthesia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hypergeusia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hypersomnia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hyposmia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Intercostal neuralgia
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Loss of consciousness
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Memory impairment
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Migraine
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Neuralgia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    4 / 451 (0.89%)
    0 / 452 (0.00%)
         occurrences all number
    4
    0
    Parosmia
         subjects affected / exposed
    3 / 451 (0.67%)
    2 / 452 (0.44%)
         occurrences all number
    3
    2
    Restless legs syndrome
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Tarsal tunnel syndrome
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Taste disorder
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Anaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Anaemia of malignant disease
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Bicytopenia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Leukopenia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Nephrogenic anaemia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Thrombocytosis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Ear pain
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    3 / 451 (0.67%)
    1 / 452 (0.22%)
         occurrences all number
    3
    1
    Vertigo positional
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Cataract
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Diabetic retinal oedema
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Diplopia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Glaucoma
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Retinal detachment
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Visual impairment
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Eyelid oedema
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Conjunctival disorder
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    3 / 451 (0.67%)
    2 / 452 (0.44%)
         occurrences all number
    3
    2
    Abdominal pain lower
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 451 (0.44%)
    2 / 452 (0.44%)
         occurrences all number
    2
    2
    Anal fissure
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Anal pruritus
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Chronic gastritis
         subjects affected / exposed
    2 / 451 (0.44%)
    2 / 452 (0.44%)
         occurrences all number
    2
    2
    Coeliac disease
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Colitis ulcerative
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    1 / 451 (0.22%)
    4 / 452 (0.88%)
         occurrences all number
    1
    4
    Diarrhoea
         subjects affected / exposed
    6 / 451 (1.33%)
    11 / 452 (2.43%)
         occurrences all number
    6
    12
    Diverticulum intestinal
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Diverticulum oesophageal
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Duodenitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Food poisoning
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    4 / 451 (0.89%)
    3 / 452 (0.66%)
         occurrences all number
    5
    3
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 451 (0.89%)
    3 / 452 (0.66%)
         occurrences all number
    4
    3
    Haematochezia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Hiatus hernia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    3 / 451 (0.67%)
    5 / 452 (1.11%)
         occurrences all number
    3
    5
    Oesophageal spasm
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Oesophagitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Reflux gastritis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Glossodynia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Odynophagia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Alopecia
         subjects affected / exposed
    7 / 451 (1.55%)
    5 / 452 (1.11%)
         occurrences all number
    8
    5
    Blister
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Dermatitis
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Drug eruption
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Eczema
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Macule
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Neurodermatitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Prurigo
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Pruritus
         subjects affected / exposed
    4 / 451 (0.89%)
    3 / 452 (0.66%)
         occurrences all number
    4
    3
    Psoriasis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    4 / 451 (0.89%)
    4 / 452 (0.88%)
         occurrences all number
    4
    4
    Rash pruritic
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Skin reaction
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Xeroderma
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Dysuria
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Oliguria
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hyperthyroidism
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hypothyroidism
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    Thyroid mass
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    3 / 451 (0.67%)
    1 / 452 (0.22%)
         occurrences all number
    4
    1
    Arthralgia
         subjects affected / exposed
    8 / 451 (1.77%)
    9 / 452 (1.99%)
         occurrences all number
    8
    10
    Arthritis
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Arthritis enteropathic
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Arthropathy
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    10 / 451 (2.22%)
    10 / 452 (2.21%)
         occurrences all number
    10
    11
    Costochondritis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Fibromyalgia
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Joint stiffness
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Mastication disorder
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Muscle contracture
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 451 (0.44%)
    3 / 452 (0.66%)
         occurrences all number
    2
    3
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    4 / 451 (0.89%)
    7 / 452 (1.55%)
         occurrences all number
    5
    7
    Myositis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    Osteoarthritis
         subjects affected / exposed
    1 / 451 (0.22%)
    3 / 452 (0.66%)
         occurrences all number
    2
    3
    Osteochondrosis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Osteoporosis
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    Plantar fasciitis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Rhabdomyolysis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Sjogren's syndrome
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Synovitis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Tendon pain
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Tendonitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis viral
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    Acute sinusitis
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    2
    Asymptomatic COVID-19
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Bed bug infestation
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Bronchiolitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Bronchitis bacterial
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    43 / 451 (9.53%)
    49 / 452 (10.84%)
         occurrences all number
    44
    49
    Mastitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    Cervicitis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Chlamydial infection
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    2 / 451 (0.44%)
    2 / 452 (0.44%)
         occurrences all number
    2
    2
    Diarrhoea infectious
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Enterobacter pneumonia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Epididymitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Furuncle
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 451 (0.44%)
    6 / 452 (1.33%)
         occurrences all number
    2
    6
    Gastroenteritis viral
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Gingivitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Gonococcal infection
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Gonorrhoea
         subjects affected / exposed
    3 / 451 (0.67%)
    0 / 452 (0.00%)
         occurrences all number
    3
    0
    H3N2 influenza
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Helicobacter gastritis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Helicobacter infection
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Herpes zoster
         subjects affected / exposed
    0 / 451 (0.00%)
    4 / 452 (0.88%)
         occurrences all number
    0
    4
    Influenza
         subjects affected / exposed
    2 / 451 (0.44%)
    4 / 452 (0.88%)
         occurrences all number
    3
    5
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    COVID-19 pneumonia
         subjects affected / exposed
    12 / 451 (2.66%)
    4 / 452 (0.88%)
         occurrences all number
    12
    4
    Nasopharyngitis
         subjects affected / exposed
    8 / 451 (1.77%)
    4 / 452 (0.88%)
         occurrences all number
    10
    4
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Otitis externa
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    2
    Otitis media
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Pharyngitis
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    3
    1
    Pneumonia bacterial
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    29 / 451 (6.43%)
    38 / 452 (8.41%)
         occurrences all number
    30
    39
    Pyelonephritis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 451 (0.67%)
    1 / 452 (0.22%)
         occurrences all number
    3
    1
    Sinusitis bacterial
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Suspected COVID-19
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Tinea pedis
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    Tonsillitis
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Tooth infection
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 451 (0.89%)
    4 / 452 (0.88%)
         occurrences all number
    4
    4
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    9 / 451 (2.00%)
    10 / 452 (2.21%)
         occurrences all number
    11
    11
    Vaginal infection
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Vestibular neuronitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Viral rhinitis
         subjects affected / exposed
    1 / 451 (0.22%)
    2 / 452 (0.44%)
         occurrences all number
    1
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 451 (0.00%)
    3 / 452 (0.66%)
         occurrences all number
    0
    3
    Onychomycosis
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Chronic sinusitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Genitourinary chlamydia infection
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Periodontitis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Syphilis
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    5 / 451 (1.11%)
    1 / 452 (0.22%)
         occurrences all number
    7
    1
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Dehydration
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Diabetes mellitus
         subjects affected / exposed
    3 / 451 (0.67%)
    2 / 452 (0.44%)
         occurrences all number
    3
    2
    Diabetes mellitus inadequate control
         subjects affected / exposed
    4 / 451 (0.89%)
    7 / 452 (1.55%)
         occurrences all number
    5
    10
    Dyslipidaemia
         subjects affected / exposed
    5 / 451 (1.11%)
    3 / 452 (0.66%)
         occurrences all number
    5
    3
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Gout
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 451 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 451 (0.00%)
    2 / 452 (0.44%)
         occurrences all number
    0
    2
    Hypernatraemia
         subjects affected / exposed
    2 / 451 (0.44%)
    0 / 452 (0.00%)
         occurrences all number
    2
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    7 / 451 (1.55%)
    9 / 452 (1.99%)
         occurrences all number
    7
    9
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    2 / 451 (0.44%)
    1 / 452 (0.22%)
         occurrences all number
    2
    1
    Weight gain poor
         subjects affected / exposed
    1 / 451 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 451 (0.22%)
    1 / 452 (0.22%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Dec 2020
    Update to the key secondary objective and associated analysis estimand to include as intercurrent events, participants who are unblinded to be considered for COVID-19 vaccination. Consequential consistency change to Section 9.4.2.1 (Primary Endpoint).
    26 Feb 2021
    COVID places pregnant women at increased risk of poor outcomes and poor pregnancy outcomes (CDC, 2021). A fetal TCR study showed no binding of AZD7442 mAbs to any fetal tissues tested. Prior experience with antibody therapy against infectious diseases and with other mAbs suggests low risk in pregnancy. Therefore, the exclusion of pregnant or breast feeding women has been removed from the CSP.
    10 Mar 2021
    Pregnant women and breastfeeding mothers are excluded from the trial (Criterion 16) as there is insufficient data on the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes or effects of the drug on the breastfed infant, or on milk production. All women of child bearing potential must have a negative pregnancy test result at Visit 1 (Criterion 8b). AstraZeneca acknowledges the risk for severe COVID-19 in pregnant women but would like to establish the risk/benefit profile in adults before including pregnant women in the clinical trial.
    31 Mar 2021
    Highly efficacious vaccines against SARS-CoV-2 are being deployed on a mass scale in the participating countries, leading to substantially decreasing attack rates for COVID-19 and reduced potential for study enrollment. Therefore, the interim analysis has been removed and the primary analysis adjusted so that it is completed 30 days after the 52nd event has occurred. This period, of 30 days, allows sufficient time for the 52nd event to be monitored, and any other events occurring during this time interval will also be evaluated. Enrollment will stop after the 52nd event has occurred.
    21 Apr 2021
    Amid a rising number of coronavirus disease 2019 (COVID-19) hospitalizations across the world, leading to a shortage of hospital beds, temporary facilities are being utilized increasingly to manage severe COVID-19 patients who would have usually been treated in a traditional hospital setting. As hospitalizations are an integral component of both the primary and key secondary endpoints in the study, further guidance is provided regarding what constitutes these temporary facility or alternate care sites used for managing participants with severe COVID-19.
    05 Jul 2021
    Due to regional differences in medical practice for COVID-19, the primary analysis population has been clarified to ensure that the efficacy of AZD7442 for the treatment of COVID-19 is assessed only in non-hospitalized adults.
    18 Mar 2022
    Cardiovascular & thrombotic events were added as AESIs which are described as potential risks in the latest IB version. A Cardiovascular Event Adjudication Committee was added to provide an independent, external, systematic, and unbiased assessment of de-identified blinded data to systematically evaluate CV events.

    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/36411267
    http://www.ncbi.nlm.nih.gov/pubmed/35688164
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