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    Clinical Trial Results:
    A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19

    Summary
    EudraCT number
    		 2020-004719-28
    Trial protocol
    		 GB  
    Global end of trial date
    25 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Aug 2023
    First version publication date
    03 Aug 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D8850C00003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    S-151, Södertälje, 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
    12 Nov 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Show efficacy and safety of AZD7442 single dose in post-exposure prophylaxis
    Protection of trial subjects
    External DSMB involved (Everest) and monthly meeting to ensure subject safety
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 15 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 98
    Country: Number of subjects enrolled
    United States: 1023
    Worldwide total number of subjects
    1121
    EEA total number of subjects
    0
    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)
    987
    From 65 to 84 years
    126
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    		 Target sample size was 1125. As this was a multi-site study there was a lag on the information of the number of subjects recruited, hence we ended up with a population slightly over 1125 (N=1131). 10 subjects were randomised in error so the full analysis set included 1121 subjects.

    Pre-assignment
    Screening details
    		 Participants will be adults ≥ 18 years of age with potential exposure, within 8 days, to a specific identified individual with laboratory-confirmed SARS-COV-2 infection, symptomatic or asymptomatic.

    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, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD7442
    Arm description
    		 Single dose 300 mg IM (AZD8895 and AZD1061)
    Arm type
    		 Experimental

    Investigational medicinal product name
    EVUSHELD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    300mg

    Arm title
    		 Placebo
    Arm description
    		 Saline placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    300mg

    Number of subjects in period 1
    		AZD7442 Placebo
    Started
    749
    372
    Completed
    624
    304
    Not completed
    125
    68
         Adverse event, serious fatal
    3
    2
         Physician decision
    1
    -
         Consent withdrawn by subject
    36
    24
         Not specified elsewhere
    3
    4
         Lost to follow-up
    82
    38

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD7442
    Reporting group description
    		 Single dose 300 mg IM (AZD8895 and AZD1061)

    Reporting group title
    Placebo
    Reporting group description
    		 Saline placebo

    Reporting group values
    		 AZD7442 Placebo Total
    Number of subjects
    		 749 372 1121
    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)
    		 658 329 987
        From 65-84 years
    		 85 41 126
        85 years and over
    		 6 2 8
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 46.62 ( 15.74 ) 45.97 ( 16.20 ) -
    Sex: Female, Male
    Full analysis set (N=1121)
    Units: Participants
        Female
    		 375 182 557
        Male
    		 374 190 564
    Race (NIH/OMB)
    Full analysis set (N=1121)
    Units: Subjects
        Unknown
    		 3 0 3
        American Indian or Alaska Native
    		 6 1 7
        Asian
    		 15 13 28
        Black or African American
    		 76 36 112
        Multiple
    		 4 4 8
        Native Hawaiian or Other Pacific Islander
    		 2 1 3
        Not reported
    		 15 3 18
        White
    		 628 314 942
    Ethnicity (NIH/OMB)
    Full analysis set (N=1121)
    Units: Subjects
        Hispanic or Latino
    		 435 210 645
        Not Hispanic or Latino
    		 299 159 458
        Not reported
    		 11 1 12
        Unknown
    		 4 2 6
    Any COVID-19 comorbidities at baseline
    Full analysis set (N=1121)
    Units: Subjects
        Yes
    		 418 210 628
        MISSING
    		 331 162 493
    Any high risk for severe COVID-19 at baseline
    Full analysis set (N=1121)
    Units: Subjects
        Yes
    		 486 243 729
        MISSING
    		 263 129 392
    SARS-CoV-2 status at baseline
    Full analysis set (N=1121)
    Units: Subjects
        Negative
    		 651 327 978
        Positive
    		 34 14 48
        MISSING
    		 64 31 95
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 168.43 ( 10.56 ) 168.57 ( 10.32 ) -
    Baseline BMI (kg/m^2)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 29.60 ( 6.67 ) 29.80 ( 6.68 ) -

    End points

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    End points reporting groups
    Reporting group title
    AZD7442
    Reporting group description
    		 Single dose 300 mg IM (AZD8895 and AZD1061)

    Reporting group title
    Placebo
    Reporting group description
    		 Saline placebo

    Primary: Number of Participants with First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness

    		 Close Top of page
    End point title
    		 Number of Participants with First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness
    End point description
    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19
    End point type
    Primary
    End point timeframe
    Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date
    End point values
    		 AZD7442 Placebo
    Number of subjects analysed
    749
    372
    Units: Participants
        n (%)
    23
    17
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Placebo v AZD7442
    Number of subjects included in analysis
    1121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.212 [1]
    Method
    		 Poisson regression
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    33.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.92
         upper limit
    		 64.68
    Notes
    [1] - not significant

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    AZD7442
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 AZD7442 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 749 (2.67%)
    16 / 372 (4.30%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    3
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung cancer metastatic
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Unevaluable event
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Near drowning
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Congenital, familial and genetic disorders
    Trisomy 21
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (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
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Basal ganglia haemorrhage
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (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
    Nephrolithiasis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 749 (0.40%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (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
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 749 (0.00%)
    3 / 372 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 749 (0.00%)
    2 / 372 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 AZD7442 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    345 / 749 (46.06%)
    191 / 372 (51.34%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    2
    Skin papilloma
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    11 / 749 (1.47%)
    5 / 372 (1.34%)
         occurrences all number
    11
    5
    Hot flush
         subjects affected / exposed
    1 / 749 (0.13%)
    3 / 372 (0.81%)
         occurrences all number
    1
    3
    Haematoma
         subjects affected / exposed
    0 / 749 (0.00%)
    2 / 372 (0.54%)
         occurrences all number
    0
    2
    Deep vein thrombosis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Accelerated hypertension
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Behcet's syndrome
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Flushing
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Pallor
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Visceral congestion
         subjects affected / exposed
    0 / 749 (0.00%)
    2 / 372 (0.54%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Vaccination site pain
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    2
    Thirst
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Swelling
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    46 / 749 (6.14%)
    32 / 372 (8.60%)
         occurrences all number
    57
    34
    Pain
         subjects affected / exposed
    39 / 749 (5.21%)
    35 / 372 (9.41%)
         occurrences all number
    44
    40
    Malaise
         subjects affected / exposed
    7 / 749 (0.93%)
    1 / 372 (0.27%)
         occurrences all number
    7
    1
    Localised oedema
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Injection site reaction
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Injection site pruritus
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    2
    Injection site pain
         subjects affected / exposed
    3 / 749 (0.40%)
    1 / 372 (0.27%)
         occurrences all number
    3
    1
    Impaired healing
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    57 / 749 (7.61%)
    39 / 372 (10.48%)
         occurrences all number
    67
    50
    Energy increased
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    32 / 749 (4.27%)
    23 / 372 (6.18%)
         occurrences all number
    34
    26
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Asthenia
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Chest discomfort
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Feeling abnormal
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Feeling cold
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Generalised oedema
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    4 / 749 (0.53%)
    2 / 372 (0.54%)
         occurrences all number
    4
    3
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Hypersensitivity
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Mycotic allergy
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Drug hypersensitivity
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Pelvic congestion
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Menstruation irregular
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    80 / 749 (10.68%)
    46 / 372 (12.37%)
         occurrences all number
    95
    58
    Acute respiratory failure
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Sneezing
         subjects affected / exposed
    3 / 749 (0.40%)
    1 / 372 (0.27%)
         occurrences all number
    3
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea
         subjects affected / exposed
    29 / 749 (3.87%)
    14 / 372 (3.76%)
         occurrences all number
    33
    18
    Epistaxis
         subjects affected / exposed
    4 / 749 (0.53%)
    1 / 372 (0.27%)
         occurrences all number
    4
    1
    Nasal congestion
         subjects affected / exposed
    50 / 749 (6.68%)
    34 / 372 (9.14%)
         occurrences all number
    64
    41
    Nasal obstruction
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    59 / 749 (7.88%)
    28 / 372 (7.53%)
         occurrences all number
    71
    34
    Pharyngeal erythema
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Productive cough
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Pulmonary congestion
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Rales
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    61 / 749 (8.14%)
    27 / 372 (7.26%)
         occurrences all number
    73
    32
    Sinus congestion
         subjects affected / exposed
    13 / 749 (1.74%)
    3 / 372 (0.81%)
         occurrences all number
    16
    3
    Tonsillar inflammation
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Aphonia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Asthma
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Paranasal sinus discomfort
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Paranasal sinus inflammation
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Pharyngeal ulceration
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Respiratory depression
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Respiratory disorder
         subjects affected / exposed
    2 / 749 (0.27%)
    1 / 372 (0.27%)
         occurrences all number
    2
    1
    Respiratory failure
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract congestion
         subjects affected / exposed
    3 / 749 (0.40%)
    0 / 372 (0.00%)
         occurrences all number
    3
    0
    Rhinitis allergic
         subjects affected / exposed
    3 / 749 (0.40%)
    0 / 372 (0.00%)
         occurrences all number
    3
    0
    Sinus pain
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Depression
         subjects affected / exposed
    1 / 749 (0.13%)
    4 / 372 (1.08%)
         occurrences all number
    1
    4
    Confusional state
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    6 / 749 (0.80%)
    2 / 372 (0.54%)
         occurrences all number
    6
    2
    Adjustment disorder
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    3 / 749 (0.40%)
    0 / 372 (0.00%)
         occurrences all number
    3
    0
    Depressed mood
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Panic attack
         subjects affected / exposed
    2 / 749 (0.27%)
    1 / 372 (0.27%)
         occurrences all number
    2
    1
    Panic disorder
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 749 (0.13%)
    5 / 372 (1.34%)
         occurrences all number
    1
    5
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 749 (0.67%)
    4 / 372 (1.08%)
         occurrences all number
    5
    4
    Blood creatine phosphokinase increased
         subjects affected / exposed
    12 / 749 (1.60%)
    4 / 372 (1.08%)
         occurrences all number
    15
    4
    Blood creatinine increased
         subjects affected / exposed
    2 / 749 (0.27%)
    1 / 372 (0.27%)
         occurrences all number
    3
    1
    Blood glucose increased
         subjects affected / exposed
    5 / 749 (0.67%)
    1 / 372 (0.27%)
         occurrences all number
    5
    1
    Glomerular filtration rate decreased
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Blood potassium decreased
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    3 / 749 (0.40%)
    2 / 372 (0.54%)
         occurrences all number
    3
    2
    C-reactive protein increased
         subjects affected / exposed
    9 / 749 (1.20%)
    3 / 372 (0.81%)
         occurrences all number
    10
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    8 / 749 (1.07%)
    4 / 372 (1.08%)
         occurrences all number
    8
    4
    Blood iron decreased
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Haematocrit decreased
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Lymph node palpable
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Red blood cell count decreased
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Red blood cells urine positive
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Urine analysis abnormal
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    White blood cell count increased
         subjects affected / exposed
    3 / 749 (0.40%)
    0 / 372 (0.00%)
         occurrences all number
    3
    0
    White blood cells urine positive
         subjects affected / exposed
    4 / 749 (0.53%)
    1 / 372 (0.27%)
         occurrences all number
    4
    1
    Haemoglobin decreased
         subjects affected / exposed
    2 / 749 (0.27%)
    1 / 372 (0.27%)
         occurrences all number
    2
    1
    Weight decreased
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Red blood cells urine
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Liver function test increased
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Body temperature increased
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Blood uric acid increased
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Blood pressure diastolic increased
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Blood potassium increased
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase abnormal
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Alanine aminotransferase abnormal
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Influenza A virus test positive
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Ligament rupture
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    5 / 749 (0.67%)
    1 / 372 (0.27%)
         occurrences all number
    7
    1
    Contusion
         subjects affected / exposed
    1 / 749 (0.13%)
    3 / 372 (0.81%)
         occurrences all number
    1
    5
    Arthropod bite
         subjects affected / exposed
    0 / 749 (0.00%)
    2 / 372 (0.54%)
         occurrences all number
    0
    2
    Road traffic accident
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Skin laceration
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    2
    Upper limb fracture
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Traumatic haemorrhage
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Soft tissue injury
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Ankle fracture
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Arthropod sting
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Back injury
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Bone contusion
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Concussion
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Exposure to toxic agent
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Face injury
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Fibula fracture
         subjects affected / exposed
    0 / 749 (0.00%)
    2 / 372 (0.54%)
         occurrences all number
    0
    2
    Joint injury
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Meniscus injury
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Neck injury
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Post procedural haematoma
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Post-traumatic pain
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Radius fracture
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Rib fracture
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Tendon injury
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Vaccination complication
         subjects affected / exposed
    4 / 749 (0.53%)
    5 / 372 (1.34%)
         occurrences all number
    7
    12
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 749 (0.00%)
    3 / 372 (0.81%)
         occurrences all number
    0
    3
    Sinus tachycardia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Chronic left ventricular failure
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Cardiac failure chronic
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Angina pectoris
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Ventricular hypokinesia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    18 / 749 (2.40%)
    14 / 372 (3.76%)
         occurrences all number
    18
    14
    Bell's palsy
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Central pain syndrome
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    4 / 749 (0.53%)
    3 / 372 (0.81%)
         occurrences all number
    4
    3
    Encephalopathy
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    86 / 749 (11.48%)
    52 / 372 (13.98%)
         occurrences all number
    109
    61
    Paraesthesia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Sciatica
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Sinus headache
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Syncope
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Anosmia
         subjects affected / exposed
    18 / 749 (2.40%)
    13 / 372 (3.49%)
         occurrences all number
    18
    13
    Dysgeusia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Lacunar infarction
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Lethargy
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Seizure
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Balance disorder
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Dizziness exertional
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Normocytic anaemia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Anaemia
         subjects affected / exposed
    5 / 749 (0.67%)
    1 / 372 (0.27%)
         occurrences all number
    6
    1
    Leukocytosis
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Lymphadenopathy
         subjects affected / exposed
    2 / 749 (0.27%)
    1 / 372 (0.27%)
         occurrences all number
    2
    1
    Lymphocytosis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Monocytosis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Blood loss anaemia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Increased tendency to bruise
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Leukopenia
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Pancytopenia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    3 / 749 (0.40%)
    1 / 372 (0.27%)
         occurrences all number
    3
    1
    Vertigo
         subjects affected / exposed
    3 / 749 (0.40%)
    2 / 372 (0.54%)
         occurrences all number
    3
    3
    Cerumen impaction
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Middle ear effusion
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Tympanic membrane disorder
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Tympanic membrane hyperaemia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Vertigo positional
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    2
    Eye swelling
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Eye movement disorder
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Eye pruritus
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Abdominal pain upper
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Constipation
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Diarrhoea
         subjects affected / exposed
    19 / 749 (2.54%)
    23 / 372 (6.18%)
         occurrences all number
    22
    28
    Dyspepsia
         subjects affected / exposed
    4 / 749 (0.53%)
    1 / 372 (0.27%)
         occurrences all number
    4
    1
    Dysphagia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Gingival swelling
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    22 / 749 (2.94%)
    23 / 372 (6.18%)
         occurrences all number
    24
    26
    Toothache
         subjects affected / exposed
    4 / 749 (0.53%)
    0 / 372 (0.00%)
         occurrences all number
    4
    0
    Umbilical hernia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    8 / 749 (1.07%)
    7 / 372 (1.88%)
         occurrences all number
    10
    7
    Chronic gastritis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Diverticulum
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Erosive oesophagitis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Food poisoning
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Haemorrhoids
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Large intestine polyp
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Oesophagitis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Periodontal disease
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Stomach mass
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Pancreatitis acute
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Cholecystitis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Gallbladder polyp
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Cullen's sign
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    2
    Hyperhidrosis
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    1 / 749 (0.13%)
    4 / 372 (1.08%)
         occurrences all number
    4
    4
    Rash
         subjects affected / exposed
    3 / 749 (0.40%)
    1 / 372 (0.27%)
         occurrences all number
    3
    1
    Alopecia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Rosacea
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    2 / 749 (0.27%)
    1 / 372 (0.27%)
         occurrences all number
    2
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Dysuria
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    2
    Glycosuria
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    2
    Haematuria
         subjects affected / exposed
    3 / 749 (0.40%)
    2 / 372 (0.54%)
         occurrences all number
    3
    2
    Micturition urgency
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    1 / 749 (0.13%)
    3 / 372 (0.81%)
         occurrences all number
    1
    4
    Pollakiuria
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    5 / 749 (0.67%)
    0 / 372 (0.00%)
         occurrences all number
    5
    0
    Leukocyturia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Renal cyst
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Urethral stenosis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Urinary bladder polyp
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Hyperplasia adrenal
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    12 / 749 (1.60%)
    2 / 372 (0.54%)
         occurrences all number
    13
    2
    Back pain
         subjects affected / exposed
    10 / 749 (1.34%)
    7 / 372 (1.88%)
         occurrences all number
    12
    7
    Seronegative arthritis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Tendonitis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Rhabdomyolysis
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Pain in extremity
         subjects affected / exposed
    5 / 749 (0.67%)
    5 / 372 (1.34%)
         occurrences all number
    5
    5
    Neck pain
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    2
    Myalgia
         subjects affected / exposed
    25 / 749 (3.34%)
    27 / 372 (7.26%)
         occurrences all number
    29
    30
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    3
    Muscle spasms
         subjects affected / exposed
    4 / 749 (0.53%)
    0 / 372 (0.00%)
         occurrences all number
    4
    0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Arthritis
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Costochondritis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Exostosis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Fibromyalgia
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    3
    0
    Foot deformity
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    2
    Myositis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bacterial vaginosis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Acute sinusitis
         subjects affected / exposed
    3 / 749 (0.40%)
    0 / 372 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Influenza
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Furuncle
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Eye infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Diverticulitis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    3 / 749 (0.40%)
    1 / 372 (0.27%)
         occurrences all number
    4
    1
    Bacteriuria
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    22 / 749 (2.94%)
    13 / 372 (3.49%)
         occurrences all number
    24
    15
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 749 (1.87%)
    3 / 372 (0.81%)
         occurrences all number
    14
    3
    Tooth infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Tooth abscess
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Tonsillitis
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Superinfection bacterial
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Sepsis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Post procedural infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    16 / 749 (2.14%)
    4 / 372 (1.08%)
         occurrences all number
    17
    6
    Periorbital cellulitis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    3 / 749 (0.40%)
    2 / 372 (0.54%)
         occurrences all number
    3
    2
    Pilonidal cyst
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Abscess
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Abscess limb
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Appendicitis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Atypical pneumonia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Bacterial infection
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Bacterial vulvovaginitis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    6 / 749 (0.80%)
    3 / 372 (0.81%)
         occurrences all number
    6
    3
    Conjunctivitis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Diarrhoea infectious
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Herpes zoster
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Hordeolum
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    2
    Localised infection
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Myringitis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Onychomycosis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    4 / 749 (0.53%)
    1 / 372 (0.27%)
         occurrences all number
    4
    1
    Pharyngitis
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Pneumonia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    2
    Sinusitis
         subjects affected / exposed
    7 / 749 (0.93%)
    4 / 372 (1.08%)
         occurrences all number
    7
    5
    Sinusitis bacterial
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Skin infection
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Vaginal infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Wound infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Pyelonephritis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Suspected COVID-19
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Asymptomatic COVID-19
         subjects affected / exposed
    7 / 749 (0.93%)
    5 / 372 (1.34%)
         occurrences all number
    7
    5
    COVID-19
         subjects affected / exposed
    117 / 749 (15.62%)
    53 / 372 (14.25%)
         occurrences all number
    125
    54
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    4 / 749 (0.53%)
    2 / 372 (0.54%)
         occurrences all number
    4
    2
    Hypophosphataemia
         subjects affected / exposed
    1 / 749 (0.13%)
    2 / 372 (0.54%)
         occurrences all number
    1
    2
    Hypokalaemia
         subjects affected / exposed
    3 / 749 (0.40%)
    1 / 372 (0.27%)
         occurrences all number
    4
    1
    Hypoglycaemia
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Hyperkalaemia
         subjects affected / exposed
    2 / 749 (0.27%)
    2 / 372 (0.54%)
         occurrences all number
    2
    2
    Hyperglycaemia
         subjects affected / exposed
    3 / 749 (0.40%)
    4 / 372 (1.08%)
         occurrences all number
    3
    4
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 749 (0.27%)
    0 / 372 (0.00%)
         occurrences all number
    2
    0
    Gout
         subjects affected / exposed
    0 / 749 (0.00%)
    2 / 372 (0.54%)
         occurrences all number
    0
    2
    Diabetes mellitus
         subjects affected / exposed
    3 / 749 (0.40%)
    3 / 372 (0.81%)
         occurrences all number
    3
    3
    Decreased appetite
         subjects affected / exposed
    4 / 749 (0.53%)
    5 / 372 (1.34%)
         occurrences all number
    4
    5
    Hyperlipidaemia
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Dehydration
         subjects affected / exposed
    4 / 749 (0.53%)
    1 / 372 (0.27%)
         occurrences all number
    4
    1
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Lactic acidosis
         subjects affected / exposed
    0 / 749 (0.00%)
    1 / 372 (0.27%)
         occurrences all number
    0
    1
    Metabolic acidosis
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 749 (0.13%)
    1 / 372 (0.27%)
         occurrences all number
    1
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 749 (0.13%)
    0 / 372 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2021
    Key amendment and rationale for change: 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. Given that the probability of a participant being exposed to COVID-19 will diminish with increased vaccination roll-out, the primary analysis will be conducted 30 days after the 25th primary endpoint event has been confirmed. This period, of 30 days, allows sufficient time for the 25th event to be monitored, and any other events occurring during this time interval will also be evaluated. To reflect this change in the timing of the primary analysis the interim analysis has been removed. Enrollment will be stopped after the 25th primary endpoint event has been confirmed, or after 1125 participants have been randomized, whichever comes first. To provide data on AZD7442 for 5 half-lives, the study has been extended to 15 months allowing a safety assessment via a phone call and an optional serum sample for PK, ADA and nAb to be added at Day 457. Study endpoints have been adjusted accordingly.

    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.
    Results are reported for the Primary analysis conducted during the study.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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