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    Clinical Trial Results:
    A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy, and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants with Conditions Causing Immune Impairment (Main Cohort/Sentinel Safety Cohort) A Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19 (Sub-study)

    Summary
    EudraCT number
    		 2022-002378-95
    Trial protocol
    		 BE   DK   DE   PL   ES   FR   SE  
    Global end of trial date
    18 Feb 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Aug 2025
    First version publication date
    24 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D7000C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151, 85, Södertälje, Sweden,
    Public contact
    AstraZeneca, Global Clinical Lead, 001 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    AstraZeneca, Global Clinical Lead, 001 877-240-9479, 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
    18 Feb 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Feb 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main Cohort: - To evaluate the safety of AZD3152 and EVUSHELD and/or placebo. - To compare the efficacy of AZD3152 to EVUSHELD and/or placebo in the prevention of symptomatic COVID-19 caused by any SARS-CoV-2 variant. - To compare the efficacy of AZD3152 to EVUSHELD and/or placebo in the prevention of symptomatic COVID 19 attributable to matched variants (variants that do not contain the F456L mutation). Sentinel: - To evaluate the safety of AZD5156 Sub-study: - To evaluate the safety of AZD3152 and EVUSHELD - To compare the predicted SARS-CoV-2 nAb responses to XBB.1.5 variant (or other circulating VOC) following AZD3152 administration vs predicted SARS-CoV-2 nAb responses to Alpha variant following EVUSHELD administration
    Protection of trial subjects
    The study was performed in compliance with International Council for Harmonisation (ICH) Good Clinical Practice, including the archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 Prior to CSP v7.0, the comparator for the Main Cohort was EVUSHELD as the immunobridging portion of the study was incorporated into the Parent study. At the request of regulatory authorities, a sub-study specifically for immunobridging was undertaken (which was conducted in the US only). As a result, the Parent study was an efficacy and safety study, and the comparator was changed to placebo.
    Actual start date of recruitment
    31 Mar 2023
    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
    Australia: 186
    Country: Number of subjects enrolled
    Belgium: 27
    Country: Number of subjects enrolled
    Denmark: 73
    Country: Number of subjects enrolled
    France: 81
    Country: Number of subjects enrolled
    Germany: 148
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Malaysia: 41
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    Singapore: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Spain: 181
    Country: Number of subjects enrolled
    Taiwan: 4
    Country: Number of subjects enrolled
    Thailand: 49
    Country: Number of subjects enrolled
    United Arab Emirates: 53
    Country: Number of subjects enrolled
    United Kingdom: 194
    Country: Number of subjects enrolled
    United States: 2727
    Country: Number of subjects enrolled
    Viet Nam: 42
    Country: Number of subjects enrolled
    Canada: 13
    Worldwide total number of subjects
    3859
    EEA total number of subjects
    528
    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)
    15
    Adults (18-64 years)
    2543
    From 65 to 84 years
    1272
    85 years and over
    29

    Subject disposition

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    Recruitment
    Recruitment details
    		 In Main Cohort, 3338 participants 12 years of age or older were randomized 1:1 to receive AZD3152 or comparator. In Sentinel Cohort, 57 participants were randomized 5:2 to receive AZD5156 (41 participants) or Placebo (16 participants). In Sub-study, 476 participants, 18 years of age or older, were randomized 2:1 to receive AZD3152 or AZD7442.

    Pre-assignment
    Screening details
    		 Overall 3713 participants were screened in the Main Study; 87 screened for the Sentinel Cohort; 576 participants were screened in the Sub-study.

    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
    		 Investigator, Monitor, Carer, Data analyst, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD3152 - Main Cohort
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD3152
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of AZD3152 300 mg IM on 2 occasions with a 6-month interval.

    Arm title
    		 AZD7442 - Main Cohort
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AZD7442
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of AZD7442, followed by placebo at 6 months.

    Arm title
    		 Placebo - Main Cohort
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (0.9% sodium chloride)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of placebo on 2 occasions with a 6-month interval.

    Arm title
    		 AZD5156 - Sentinel Cohort
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD5156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose 600 mg AZD5156 at Day 1

    Arm title
    		 Placebo - Sentinel Cohort
    Arm description
    		 -
    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
    1 dose placebo at Day 1

    Arm title
    		 AZD3152 1200 mg - Sub Study
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD3152
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of AZD3152 1200 mg at Day 1

    Arm title
    		 EVUSHELD 300 mg - Sub Study
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EVUSHELD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of EVUSHELD 300 mg at Day 1; immunocompromised participants who received EVUSHELD at Day 1 were offered the option of receiving AZD3152 1200 mg after Day 29 assessment.

    Number of subjects in period 1
    		AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort AZD5156 - Sentinel Cohort Placebo - Sentinel Cohort AZD3152 1200 mg - Sub Study EVUSHELD 300 mg - Sub Study
    Started
    1671
    1102
    561
    41
    16
    310
    158
    Completed
    1469
    962
    513
    37
    13
    277
    142
    Not completed
    202
    140
    48
    4
    3
    33
    16
         Adverse event, serious fatal
    40
    24
    6
    1
    -
    2
    -
         Physician decision
    18
    15
    3
    -
    -
    1
    3
         Consent withdrawn by subject
    90
    71
    23
    -
    1
    14
    3
         Adverse event, non-fatal
    3
    1
    -
    -
    -
    -
    1
         Lost to follow-up
    47
    29
    14
    3
    2
    15
    7
         Missing reason
    4
    -
    2
    -
    -
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD3152 - Main Cohort
    Reporting group description
    		 -

    Reporting group title
    AZD7442 - Main Cohort
    Reporting group description
    		 -

    Reporting group title
    Placebo - Main Cohort
    Reporting group description
    		 -

    Reporting group title
    AZD5156 - Sentinel Cohort
    Reporting group description
    		 -

    Reporting group title
    Placebo - Sentinel Cohort
    Reporting group description
    		 -

    Reporting group title
    AZD3152 1200 mg - Sub Study
    Reporting group description
    		 -

    Reporting group title
    EVUSHELD 300 mg - Sub Study
    Reporting group description
    		 -

    Reporting group values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort AZD5156 - Sentinel Cohort Placebo - Sentinel Cohort AZD3152 1200 mg - Sub Study EVUSHELD 300 mg - Sub Study Total
    Number of subjects
    		 1671 1102 561 41 16 310 158 3859
    Age Categorical
    Units: participants
        In utero
    		 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 8 7 0 0 0 0 0 15
        Adults (18-64 years)
    		 1057 678 375 41 16 250 126 2543
        From 65-84 years
    		 597 403 181 0 0 60 31 1272
        85 years and over
    		 9 14 5 0 0 0 1 29
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.1 ( 13.9 ) 58.6 ( 13.7 ) 57.7 ( 13.2 ) 35.2 ( 11.2 ) 32.3 ( 9.5 ) 48.9 ( 15.8 ) 48.6 ( 16.9 ) -
    Gender Categorical
    Units: participants
        Female
    		 954 610 329 23 11 169 94 2190
        Male
    		 717 492 232 18 5 141 64 1669
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 356 235 125 2 0 86 40 844
        Not Hispanic or Latino
    		 1240 841 386 37 14 222 116 2856
        Not reported
    		 75 26 50 2 2 2 2 159
    Race
    Units: Subjects
        Black or African American
    		 202 122 78 11 4 66 33 516
        Native Hawaiian or Other Pacific Islander
    		 5 2 0 0 0 2 0 9
        American Indian or Alaska Native
    		 1 2 2 0 0 0 1 6
        White
    		 1241 814 416 27 9 233 118 2858
        Other
    		 133 123 22 3 3 6 5 295
        Multiple
    		 42 31 2 0 0 2 1 78
        Not reported
    		 38 8 29 0 0 1 0 76
        Missing
    		 9 0 12 0 0 0 0 21
    SARS-CoV-2 vaccination status within 6 months prior to randomization
    Units: Subjects
        Yes SARS-CoV-2 vaccination
    		 199 147 50 3 2 13 5 419
        No SARS-CoV-2 vaccination
    		 1472 955 511 38 14 297 153 3440
    Prior SARS-CoV-2 infection within 6 months prior to randomization
    Units: Subjects
        Yes prior SARS-CoV-2 infection
    		 66 58 7 1 0 2 1 135
        No prior SARS-CoV-2 infection
    		 1605 1044 554 40 16 308 157 3724
    EVUSHELD use within 12 months prior to randomization
    Units: Subjects
        Yes EVUSHELD use
    		 191 148 39 0 0 0 0 378
        No EVUSHELD use
    		 1480 954 522 41 16 0 0 3013
        Missing
    		 0 0 0 0 0 310 158 468

    End points

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    End points reporting groups
    Reporting group title
    AZD3152 - Main Cohort
    Reporting group description
    		 -

    Reporting group title
    AZD7442 - Main Cohort
    Reporting group description
    		 -

    Reporting group title
    Placebo - Main Cohort
    Reporting group description
    		 -

    Reporting group title
    AZD5156 - Sentinel Cohort
    Reporting group description
    		 -

    Reporting group title
    Placebo - Sentinel Cohort
    Reporting group description
    		 -

    Reporting group title
    AZD3152 1200 mg - Sub Study
    Reporting group description
    		 -

    Reporting group title
    EVUSHELD 300 mg - Sub Study
    Reporting group description
    		 -

    Primary: (Main Cohort) Occurrence of AEs collected through approximately 90 days after each IMP administration; SAEs, MAAEs, and AESIs collected throughout the study

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    End point title
    		 (Main Cohort) Occurrence of AEs collected through approximately 90 days after each IMP administration; SAEs, MAAEs, and AESIs collected throughout the study [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    through 90 days post IMP administration (AEs); throughout the study (SAEs, MAAEs, and AESIs)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1671
    1102
    561
    Units: Participants
        AEs
    846
    591
    273
        SAEs
    315
    222
    90
        MAAEs
    976
    651
    297
        AESIs
    45
    18
    9
    No statistical analyses for this end point

    Primary: (Sub-study) Occurrence of AEs collected through 29 days after IMP administration. SAEs, MAAEs, and AESIs collected throughout the study for the final analysis.

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    End point title
    		 (Sub-study) Occurrence of AEs collected through 29 days after IMP administration. SAEs, MAAEs, and AESIs collected throughout the study for the final analysis. [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    through 29 days post IMP administration (AEs); throughout the study (SAEs, MAAEs, and AESIs)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 1200 mg - Sub Study EVUSHELD 300 mg - Sub Study
    Number of subjects analysed
    310
    158
    Units: participants
        AE
    81
    33
        SAE
    15
    11
        MAAE
    89
    65
        AESI
    9
    1
    No statistical analyses for this end point

    Primary: (Sub-study) Predicted SARS-CoV-2 nAb titers derived from serum PK and in vitro IC50 for SARS-CoV-2 variants BA.2.86 following AZD3152 administration and Alpha variant following EVUSHELD administration.

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    End point title
    		 (Sub-study) Predicted SARS-CoV-2 nAb titers derived from serum PK and in vitro IC50 for SARS-CoV-2 variants BA.2.86 following AZD3152 administration and Alpha variant following EVUSHELD administration. [5]
    End point description
    End point type
    Primary
    End point timeframe
    at Day 29
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 1200 mg - Sub Study EVUSHELD 300 mg - Sub Study
    Number of subjects analysed
    281
    141
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        AZD3152 [BA.2.86] / AZD7442 [Alpha]
    36127.1 ( 0.56 )
    8882.5 ( 0.61 )
    Statistical analysis title
    		 Comparison for predicted nAb titers
    Statistical analysis description
    The GMTR and its confidence intervals are estimated from an Analysis of Variance Model that includes the log10-transformed predicted nAb titers at Day 29 as the response variable and treatment arm as the primary explanatory variable.
    Comparison groups
    AZD3152 1200 mg - Sub Study v EVUSHELD 300 mg - Sub Study
    Number of subjects included in analysis
    422
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANOVA
    Parameter type
    		 GMTR
    Point estimate
    4.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.65
         upper limit
    		 4.53
    Statistical analysis title
    		 Comparison for predicted nAb titers
    Statistical analysis description
    The geometric mean titer ratio (GMTR) and its confidence intervals are estimated from an Analysis of Variance Model that includes the log10-transformed predicted nAb titers at Day 29 as the response variable and treatment arm as the primary explanatory variable.
    Comparison groups
    AZD3152 1200 mg - Sub Study v EVUSHELD 300 mg - Sub Study
    Number of subjects included in analysis
    422
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 ANOVA
    Parameter type
    		 GMTR
    Point estimate
    4.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 3.71
         upper limit
    		 4.46

    Primary: (Main Cohort) Confirmed symptomatic COVID-19 case

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    End point title
    		 (Main Cohort) Confirmed symptomatic COVID-19 case [6]
    End point description
    End point type
    Primary
    End point timeframe
    at Primary Analysis
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1649
    1082
    549
    Units: participants
    122
    117
    61
    Statistical analysis title
    		 dual primary endpoint testing by Holm procedure
    Statistical analysis description
    Comparator group combined AZD7442/Placebo groups. Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts follow-up time.
    Comparison groups
    AZD3152 - Main Cohort v AZD7442 - Main Cohort v Placebo - Main Cohort
    Number of subjects included in analysis
    3280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [7]
    Method
    		 Poisson regression
    Parameter type
    		 relative risk reduction, %
    Point estimate
    34.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 15
         upper limit
    		 50.1
    Notes
    [7] - first-ranked p-value in Holm procedure

    Primary: (Main Cohort) Confirmed symptomatic COVID-19 case attributable to matched variants

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    End point title
    		 (Main Cohort) Confirmed symptomatic COVID-19 case attributable to matched variants [8]
    End point description
    End point type
    Primary
    End point timeframe
    at Primary Analysis
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1649
    1082
    549
    Units: participants
    54
    55
    35
    Statistical analysis title
    		 dual primary endpoint testing by Holm procedure
    Statistical analysis description
    Comparator group combined AZD7442/Placebo groups. Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts follow-up time.
    Comparison groups
    AZD3152 - Main Cohort v AZD7442 - Main Cohort v Placebo - Main Cohort
    Number of subjects included in analysis
    3280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [9]
    Method
    		 Poisson regression
    Parameter type
    		 relative risk reduction, %
    Point estimate
    42.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.9
         upper limit
    		 59.3
    Notes
    [9] - second-ranked p-value in Holm procedure

    Primary: (Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs collected throughout the study

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    End point title
    		 (Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs collected throughout the study [10] [11]
    End point description
    End point type
    Primary
    End point timeframe
    throughout the study
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD5156 - Sentinel Cohort Placebo - Sentinel Cohort
    Number of subjects analysed
    41
    16
    Units: participants
        AEs
    19
    12
        SAEs
    2
    0
        MAAEs
    9
    3
        AESIs
    0
    0
    No statistical analyses for this end point

    Secondary: (Sub-study) AZD3152 and EVUSHELD concentrations in serum, over time

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    End point title
    		 (Sub-study) AZD3152 and EVUSHELD concentrations in serum, over time [12]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 29, Day 91, Day 181
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 1200 mg - Sub Study EVUSHELD 300 mg - Sub Study
    Number of subjects analysed
    299
    154
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        Day 29
    133.4 ( 0.72 )
    21.2 ( 0.62 )
        Day 91
    69.6 ( 0.82 )
    14.6 ( 0.67 )
        Day 181
    30.3 ( 1.64 )
    6.6 ( 1.00 )
    No statistical analyses for this end point

    Secondary: (Sub-study) Incidence of ADA to AZD3152 and EVUSHELD

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    End point title
    		 (Sub-study) Incidence of ADA to AZD3152 and EVUSHELD [13]
    End point description
    AZD3152 recipients were tested for ADA to AZD3152; EVUSHELD recipients were tested for ADA to EVUSHELD.
    End point type
    Secondary
    End point timeframe
    through Day 181
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 1200 mg - Sub Study EVUSHELD 300 mg - Sub Study
    Number of subjects analysed
    297
    151
    Units: participants
        Treatment-emergent ADA positive (ADA incidence)
    2
    0
    No statistical analyses for this end point

    Secondary: (Sub-study) Cilgavimab and tixagevimab concentrations in serum, over time

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    End point title
    		 (Sub-study) Cilgavimab and tixagevimab concentrations in serum, over time [14]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 29, Day 91, Day 181
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 EVUSHELD 300 mg - Sub Study
    Number of subjects analysed
    154
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        Cilgavimab: Day 29
    8.9 ( 0.65 )
        Cilgavimab: Day 91
    7.0 ( 0.68 )
        Cilgavimab: Day 181
    3.2 ( 0.84 )
        Tixagevimab: Day 29
    9.4 ( 0.64 )
        Tixagevimab: Day 91
    7.6 ( 0.66 )
        Tixagevimab: Day 181
    3.5 ( 0.89 )
    No statistical analyses for this end point

    Secondary: (Sub-study) ADA titers

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    End point title
    		 (Sub-study) ADA titers [15]
    End point description
    ADA titers were only available for ADA positive samples.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 29, Day 91, Day 181
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 1200 mg - Sub Study EVUSHELD 300 mg - Sub Study
    Number of subjects analysed
    297
    151
    Units: ADA titers
    median (full range (min-max))
        Day 1
    200 (100 to 800)
    80 (40 to 640)
        Day 29
    0 (0 to 0)
    80 (40 to 160)
        Day 91
    100 (100 to 100)
    80 (40 to 160)
        Day 181
    100 (100 to 400)
    80 (80 to 80)
    No statistical analyses for this end point

    Secondary: (Main Cohort) Symptomatic COVID‑19 case (negative RT‑PCR at baseline to positive at any time up 12 months with all observed events at final readout) caused by any SARS‑CoV‑2 matched variant

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    End point title
    		 (Main Cohort) Symptomatic COVID‑19 case (negative RT‑PCR at baseline to positive at any time up 12 months with all observed events at final readout) caused by any SARS‑CoV‑2 matched variant [16]
    End point description
    first secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1649
    1082
    549
    Units: participants
    59
    56
    37
    Statistical analysis title
    		 Hypothesis testing
    Statistical analysis description
    Comparator group combined AZD7442/Placebo groups. Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts follow-up time.
    Comparison groups
    AZD3152 - Main Cohort v AZD7442 - Main Cohort v Placebo - Main Cohort
    Number of subjects included in analysis
    3280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Poisson regression
    Parameter type
    		 relative risk reduction, %
    Point estimate
    39.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.2
         upper limit
    		 56.7

    Secondary: (Main Cohort) Symptomatic COVID‑19 case (negative RT‑PCR at baseline to positive at any time up to 12 months with all observed events at final readout) caused by any SARS‑CoV‑2 variants

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    End point title
    		 (Main Cohort) Symptomatic COVID‑19 case (negative RT‑PCR at baseline to positive at any time up to 12 months with all observed events at final readout) caused by any SARS‑CoV‑2 variants [17]
    End point description
    second secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1649
    1082
    549
    Units: participants
    175
    147
    79
    Statistical analysis title
    		 Hypothesis testing
    Statistical analysis description
    Comparator group combined AZD7442/Placebo groups. Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts follow-up time.
    Comparison groups
    AZD3152 - Main Cohort v AZD7442 - Main Cohort v Placebo - Main Cohort
    Number of subjects included in analysis
    3280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Poisson regression
    Parameter type
    		 relative risk reduction, %
    Point estimate
    26.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.7
         upper limit
    		 40.2

    Secondary: (Main Cohort) Severe COVID‑19 caused by any SARS‑CoV‑2 variant any time up to 12 months

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    End point title
    		 (Main Cohort) Severe COVID‑19 caused by any SARS‑CoV‑2 variant any time up to 12 months [18]
    End point description
    third secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1649
    1082
    549
    Units: participants
    3
    3
    3
    Statistical analysis title
    		 Hypothesis testing
    Statistical analysis description
    Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts for follow-up time. Only participants with non-missing covariates are included in the analysis. If there is 0 event at any level of a stratification factor, then the stratification factor is dropped from the model.
    Comparison groups
    AZD3152 - Main Cohort v AZD7442 - Main Cohort v Placebo - Main Cohort
    Number of subjects included in analysis
    3280
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 = 0.308
    Method
    		 Poisson regression
    Parameter type
    		 relative risk reduction, %
    Point estimate
    51.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -95.1
         upper limit
    		 87.9
    Notes
    [19] - The test result was not significant, hierarchical testing procedure stopped.

    Secondary: (Main Cohort) Composite of COVID‑19-related hospitalization and/or COVID‑19-related death (WHO COVID‑19 Clinical Progression Scale score ≥ 4) any time up to 12 months

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    End point title
    		 (Main Cohort) Composite of COVID‑19-related hospitalization and/or COVID‑19-related death (WHO COVID‑19 Clinical Progression Scale score ≥ 4) any time up to 12 months [20]
    End point description
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1649
    1082
    549
    Units: participants
    16
    10
    4
    No statistical analyses for this end point

    Secondary: (Main Cohort) Severe COVID‑19 caused by any SARS‑CoV‑2 matched variants at any time up to 12 months

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    End point title
    		 (Main Cohort) Severe COVID‑19 caused by any SARS‑CoV‑2 matched variants at any time up to 12 months [21]
    End point description
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1649
    1082
    549
    Units: participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: (Main Cohort) COVID‑19-related hospitalization any time up to 12 months

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    End point title
    		 (Main Cohort) COVID‑19-related hospitalization any time up to 12 months [22]
    End point description
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1649
    1082
    549
    Units: participants
    16
    10
    4
    No statistical analyses for this end point

    Secondary: (Main Cohort) COVID-19 related death

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    End point title
    		 (Main Cohort) COVID-19 related death [23]
    End point description
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1649
    1082
    549
    Units: participants
    0
    1
    0
    No statistical analyses for this end point

    Secondary: (Main Cohort) GMT and GMFR of SARS-CoV-2 nAbs at Day 29

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    End point title
    		 (Main Cohort) GMT and GMFR of SARS-CoV-2 nAbs at Day 29 [24]
    End point description
    End point type
    Secondary
    End point timeframe
    at Day 29
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort Placebo - Main Cohort
    Number of subjects analysed
    1422
    1020
    484
    Units: 1/dilution; ratio
    geometric mean (confidence interval 95%)
        Alpha/B.1.1.7 GMC
    6400.09 (5848.79 to 7003.36)
    60287.63 (54951.89 to 66141.45)
    2932.50 (2616.48 to 3286.70)
        Alpha/B.1.1.7 GMFR
    2.54 (2.33 to 2.78)
    23.97 (21.85 to 26.30)
    1.17 (1.04 to 1.31)
        BA.2 GMC
    2928.45 (2678.52 to 3201.71)
    8924.49 (8141.14 to 9783.23)
    1029.20 (918.57 to 1153.16)
        BA.2 GMFR
    3.20 (2.92 to 3.49)
    9.74 (8.89 to 10.68)
    1.12 (1.00 to 1.26)
        BA.4/5 GMC
    4026.99 (3683.40 to 4402.63)
    2975.84 (2714.31 to 3262.57)
    840.04 (749.95 to 940.95)
        BA.4/5 GMFR
    5.68 (5.20 to 6.21)
    4.20 (3.83 to 4.60)
    1.19 (1.06 to 1.33)
        XBB.1.5 GMC
    2385.68 (2143.34 to 2655.42)
    151.79 (135.82 to 169.64)
    196.29 (170.85 to 225.53)
        XBB.1.5 GMFR
    15.69 (14.09 to 17.46)
    1.00 (0.89 to 1.12)
    1.29 (1.12 to 1.48)
    No statistical analyses for this end point

    Secondary: (Main Cohort) AZD3152 and AZD7442 (EVUSHELD) concentrations over time

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    End point title
    		 (Main Cohort) AZD3152 and AZD7442 (EVUSHELD) concentrations over time [25]
    End point description
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort
    Number of subjects analysed
    895
    780
    Units: mg/L
    geometric mean (geometric coefficient of variation)
        Day 29
    30.1 ( 35.9 )
    61.0 ( 41.5 )
        Day 91
    18.2 ( 49.8 )
    35.0 ( 56.8 )
        Day 181
    8.9 ( 85.9 )
    15.6 ( 68.5 )
        Day 189
    33.4 ( 73.0 )
    14.6 ( 72.3 )
        Day 210
    33.0 ( 50.8 )
    12.5 ( 75.7 )
        Day 361
    12.0 ( 67.4 )
    3.7 ( 80.7 )
    No statistical analyses for this end point

    Secondary: (Sentinel Cohort) AZD5156, AZD1061, and AZD3152 concentrations over time

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    End point title
    		 (Sentinel Cohort) AZD5156, AZD1061, and AZD3152 concentrations over time [26]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 29, Day 181, Day 361
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD5156 - Sentinel Cohort
    Number of subjects analysed
    20
    Units: mg/L
    geometric mean (geometric coefficient of variation)
        Day 29 AZD5156 gluteal
    40.1 ( 55.7 )
        Day 181 AZD5156 gluteal
    10.7 ( 114.1 )
        Day 361 AZD5156 gluteal
    1.9 ( 256.8 )
        Day 29 AZD5156 thigh
    71.0 ( 24.2 )
        Day 181 AZD5156 thigh
    19.3 ( 107.1 )
        Day 361 AZD5156 thigh
    3.2 ( 263.6 )
        Day 29 AZD3152 gluteal
    21.4 ( 53.9 )
        Day 181 AZD3152 gluteal
    6.2 ( 109.2 )
        Day 361 AZD3152 gluteal
    1.3 ( 185.8 )
        Day 29 AZD3152 thigh
    34.9 ( 27.1 )
        Day 181 AZD3152 thigh
    10.4 ( 107.5 )
        Day 361 AZD3152 thigh
    2.0 ( 188.8 )
        Day 29 AZD1061 gluteal
    18.5 ( 61.9 )
        Day 181 AZD1061 gluteal
    4.5 ( 123.7 )
        Day 361 AZD1061 gluteal
    0.9 ( 149.5 )
        Day 29 AZD1061 thigh
    36.0 ( 23.4 )
        Day 181 AZD1061 thigh
    8.9 ( 106.9 )
        Day 361 AZD1061 thigh
    1.6 ( 159.3 )
    No statistical analyses for this end point

    Secondary: (Main Cohort) Incidence of ADA to AZD3152 and AZD7442 (EVUSHELD)

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    End point title
    		 (Main Cohort) Incidence of ADA to AZD3152 and AZD7442 (EVUSHELD) [27]
    End point description
    AZD3152 recipients were tested for ADA to AZD3152; AZD7442 recipients were tested for ADA to AZD7442.
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort
    Number of subjects analysed
    560
    605
    Units: ADA titers
        Treatment-emergent ADA-positive (ADA incidence)
    4
    3
    No statistical analyses for this end point

    Secondary: (Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061

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    End point title
    		 (Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061 [28]
    End point description
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD5156 - Sentinel Cohort
    Number of subjects analysed
    40
    Units: ADA titers
        Treatment-emergent ADA to AZD5156 -positive
    0
        Treatment-emergent ADA to AZD3152 -positive
    0
        Treatment-emergent ADA to AZD1061 -positive
    0
    No statistical analyses for this end point

    Secondary: (Main Cohort) ADA titers

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    End point title
    		 (Main Cohort) ADA titers [29]
    End point description
    ADA titers were only available for ADA positive samples.
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD3152 - Main Cohort AZD7442 - Main Cohort
    Number of subjects analysed
    560
    605
    Units: ADA titers
    median (full range (min-max))
        Baseline
    400 (100 to 1600)
    80 (40 to 20480)
        Day 29
    200 (100 to 800)
    80 (40 to 20480)
        Day 91
    150 (100 to 400)
    80 (40 to 20480)
        Day 181 (pre-dose)
    150 (100 to 400)
    80 (40 to 20480)
        Day 210
    200 (100 to 800)
    120 (40 to 10240)
    No statistical analyses for this end point

    Secondary: (Main Cohort) AZD1061 and AZD8895 concentrations over time

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    End point title
    		 (Main Cohort) AZD1061 and AZD8895 concentrations over time [30]
    End point description
    End point type
    Secondary
    End point timeframe
    through Day 361
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety data was planned to be summarized in a descriptive way without hypothesis testing.
    End point values
    		 AZD7442 - Main Cohort
    Number of subjects analysed
    780
    Units: mg/L
    geometric mean (geometric coefficient of variation)
        Day 29 AZD1061
    30.1 ( 42.4 )
        Day 91 AZD1061
    17.0 ( 57.3 )
        Day 181 AZD1061
    7.3 ( 68.0 )
        Day 189 AZD1061
    6.8 ( 71.3 )
        Day 210 AZD1061
    5.9 ( 70.3 )
        Day 361 AZD1061
    1.7 ( 69.4 )
        Day 29 AZD8895
    31.1 ( 39.0 )
        Day 91 AZD8895
    18.0 ( 55.7 )
        Day 181 AZD8895
    8.3 ( 67.8 )
        Day 189 AZD8895
    7.8 ( 72.2 )
        Day 210 AZD8895
    6.7 ( 73.4 )
        Day 361 AZD8895
    2.2 ( 77.6 )
    No statistical analyses for this end point

    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
    27.0
    Reporting groups
    Reporting group title
    AZD3152- Main Cohort
    Reporting group description
    		 -

    Reporting group title
    AZD7442- Main Cohort
    Reporting group description
    		 -

    Reporting group title
    Placebo- Main Cohort
    Reporting group description
    		 -

    Reporting group title
    EVUSHELD 300 mg- Sub Study
    Reporting group description
    		 -

    Reporting group title
    AZD3152 1200 mg- Sub Study
    Reporting group description
    		 -

    Reporting group title
    AZD5156- Sentinel Cohort
    Reporting group description
    		 -

    Reporting group title
    Placebo- Sentinel Cohort
    Reporting group description
    		 -

    Serious adverse events
    		 AZD3152- Main Cohort AZD7442- Main Cohort Placebo- Main Cohort EVUSHELD 300 mg- Sub Study AZD3152 1200 mg- Sub Study AZD5156- Sentinel Cohort Placebo- Sentinel Cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    315 / 1671 (18.85%)
    222 / 1102 (20.15%)
    90 / 561 (16.04%)
    11 / 158 (6.96%)
    15 / 310 (4.84%)
    2 / 41 (4.88%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    40
    24
    6
    0
    2
    1
    0
         number of deaths resulting from adverse events
    40
    24
    6
    0
    2
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia refractory
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaplastic large cell lymphoma T- and null-cell types
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-cell small lymphocytic lymphoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system lymphoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    3 / 1102 (0.27%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Follicular lymphoma stage IV
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Follicular lymphoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer metastatic
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    2 / 1671 (0.12%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer metastatic
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hormone receptor positive breast cancer
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    High-grade B-cell lymphoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mantle cell lymphoma recurrent
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Marginal zone lymphoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer stage IV
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer stage IV
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma recurrent
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin squamous cell carcinoma metastatic
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma metastatic
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Throat cancer
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aneurysm ruptured
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dialysis hypotension
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brachiocephalic vein thrombosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial thrombosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    8 / 1671 (0.48%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 1671 (0.06%)
    4 / 1102 (0.36%)
    2 / 561 (0.36%)
    1 / 158 (0.63%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    5 / 1671 (0.30%)
    6 / 1102 (0.54%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    4 / 1671 (0.24%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    4 / 1671 (0.24%)
    2 / 1102 (0.18%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superficial vein thrombosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous stenosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Toe amputation
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adhesion
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 1671 (0.06%)
    3 / 1102 (0.27%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    2 / 1671 (0.12%)
    2 / 1102 (0.18%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injection site necrosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 1671 (0.12%)
    2 / 1102 (0.18%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    5 / 1671 (0.30%)
    3 / 1102 (0.27%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney transplant rejection
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related hypersensitivity reaction
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytokine release syndrome
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anti-neutrophil cytoplasmic antibody positive vasculitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transplant rejection
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver transplant rejection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic pain
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    7 / 1671 (0.42%)
    9 / 1102 (0.82%)
    3 / 561 (0.53%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    5 / 1671 (0.30%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    5 / 1671 (0.30%)
    3 / 1102 (0.27%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic rhinosinusitis with nasal polyps
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 1671 (0.18%)
    3 / 1102 (0.27%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    8 / 1671 (0.48%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    2 / 310 (0.65%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus pleurisy
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 1671 (0.12%)
    3 / 1102 (0.27%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    7 / 1671 (0.42%)
    4 / 1102 (0.36%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary infarction
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 1671 (0.06%)
    3 / 1102 (0.27%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    International normalised ratio increased
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza A virus test positive
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anastomotic ulcer
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula site complication
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula occlusion
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous graft thrombosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complications of transplanted kidney
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis radiation
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis postoperative
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia, obstructive
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyphaema
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrostomy tube site complication
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft haemorrhage
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural fever
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative respiratory failure
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal transplant failure
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spleen contusion
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular access site thrombosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Haemorrhagic arteriovenous malformation
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute right ventricular failure
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    15 / 1671 (0.90%)
    11 / 1102 (1.00%)
    3 / 561 (0.53%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 12
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    3 / 1671 (0.18%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    12 / 1671 (0.72%)
    7 / 1102 (0.64%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    7 / 1671 (0.42%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 7
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    8 / 1671 (0.48%)
    4 / 1102 (0.36%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    11 / 1671 (0.66%)
    10 / 1102 (0.91%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    3 / 1671 (0.18%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart failure with preserved ejection fraction
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart failure with reduced ejection fraction
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    3 / 561 (0.53%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    4 / 1671 (0.24%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachyarrhythmia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    3 / 1671 (0.18%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain stem haemorrhage
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system lupus
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem stroke
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    6 / 1671 (0.36%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral microinfarction
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Focal dyscognitive seizures
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic intracranial hypertension
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    3 / 1671 (0.18%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis crisis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurotoxicity
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    7 / 1671 (0.42%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phrenic nerve paralysis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    3 / 1671 (0.18%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    3 / 1671 (0.18%)
    6 / 1102 (0.54%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune neutropenia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bicytopenia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    6 / 1671 (0.36%)
    5 / 1102 (0.45%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune-mediated pancytopenia
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrogenic anaemia
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic retinal oedema
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    5 / 1671 (0.30%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    3 / 1671 (0.18%)
    0 / 1102 (0.00%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall cyst
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula of small intestine
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral hernia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 1671 (0.18%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal polyp haemorrhage
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal ulcer perforation
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Internal hernia
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedematous pancreatitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral macule
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    2 / 310 (0.65%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 1671 (0.06%)
    3 / 1102 (0.27%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    4 / 1671 (0.24%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus of small bowel
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 1671 (0.18%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    4 / 1671 (0.24%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute cholecystitis necrotic
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erythema nodosum
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin mass
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder perforation
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    11 / 1671 (0.66%)
    8 / 1102 (0.73%)
    4 / 561 (0.71%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
    0 / 5
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcapsular renal haematoma
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroid disorder
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondrocalcinosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture nonunion
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immunoglobulin G4 related disease
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint destruction
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sacroiliitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    3 / 1671 (0.18%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    2 / 1671 (0.12%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous graft site infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula site infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asymptomatic bacteriuria
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspergillus infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    4 / 1671 (0.24%)
    5 / 1102 (0.45%)
    5 / 561 (0.89%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    15 / 1671 (0.90%)
    10 / 1102 (0.91%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 10
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis pneumococcal
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis haemophilus
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis enterococcal
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    6 / 1671 (0.36%)
    4 / 1102 (0.36%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site cellulitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac valve vegetation
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    4 / 1671 (0.24%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Citrobacter bacteraemia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis escherichia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue haemorrhagic fever
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated cryptococcosis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    4 / 1102 (0.36%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis intestinal perforated
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysematous cystitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysematous pyelonephritis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalomyelitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 1671 (0.18%)
    2 / 1102 (0.18%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    3 / 1671 (0.18%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    6 / 1671 (0.36%)
    3 / 1102 (0.27%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    JC virus infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Histoplasmosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device site joint infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metapneumovirus pneumonia
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising soft tissue infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 1671 (0.00%)
    4 / 1102 (0.36%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Norovirus infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    3 / 1671 (0.18%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    3 / 1671 (0.18%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal disease
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    32 / 1671 (1.92%)
    15 / 1102 (1.36%)
    6 / 561 (1.07%)
    1 / 158 (0.63%)
    1 / 310 (0.32%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 15
    0 / 6
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    3 / 1671 (0.18%)
    0 / 1102 (0.00%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia necrotising
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Progressive multifocal leukoencephalopathy
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia serratia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal graft infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyomyositis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 1671 (0.12%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 1671 (0.12%)
    2 / 1102 (0.18%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic pulmonary embolism
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    12 / 1671 (0.72%)
    9 / 1102 (0.82%)
    4 / 561 (0.71%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
    0 / 4
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rickettsiosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    14 / 1671 (0.84%)
    4 / 1102 (0.36%)
    3 / 561 (0.53%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    4 / 1671 (0.24%)
    1 / 1102 (0.09%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stenotrophomonas infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stenotrophomonas maltophilia pneumonia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    8 / 1671 (0.48%)
    6 / 1102 (0.54%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superinfection bacterial
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    4 / 1671 (0.24%)
    3 / 1102 (0.27%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular access site cellulitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral sepsis
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound cellulitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 1671 (0.06%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    8 / 1671 (0.48%)
    8 / 1102 (0.73%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 12
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 1671 (0.06%)
    3 / 1102 (0.27%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    11 / 1671 (0.66%)
    10 / 1102 (0.91%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 14
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 1671 (0.00%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 AZD3152- Main Cohort AZD7442- Main Cohort Placebo- Main Cohort EVUSHELD 300 mg- Sub Study AZD3152 1200 mg- Sub Study AZD5156- Sentinel Cohort Placebo- Sentinel Cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    892 / 1671 (53.38%)
    627 / 1102 (56.90%)
    295 / 561 (52.58%)
    18 / 158 (11.39%)
    39 / 310 (12.58%)
    19 / 41 (46.34%)
    12 / 16 (75.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    51 / 1671 (3.05%)
    40 / 1102 (3.63%)
    21 / 561 (3.74%)
    2 / 158 (1.27%)
    5 / 310 (1.61%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    54
    41
    22
    2
    5
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    39 / 1671 (2.33%)
    26 / 1102 (2.36%)
    8 / 561 (1.43%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    40
    29
    8
    0
    0
    0
    1
    Injection site pain
         subjects affected / exposed
    33 / 1671 (1.97%)
    29 / 1102 (2.63%)
    7 / 561 (1.25%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    2 / 41 (4.88%)
    2 / 16 (12.50%)
         occurrences all number
    34
    33
    8
    1
    0
    2
    3
    Injection site pruritus
         subjects affected / exposed
    3 / 1671 (0.18%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    3
    2
    0
    0
    0
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    4 / 1671 (0.24%)
    4 / 1102 (0.36%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    4
    4
    2
    0
    0
    1
    0
    Peripheral swelling
         subjects affected / exposed
    4 / 1671 (0.24%)
    2 / 1102 (0.18%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    4
    2
    2
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    53 / 1671 (3.17%)
    43 / 1102 (3.90%)
    15 / 561 (2.67%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    62
    45
    20
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    98 / 1671 (5.86%)
    69 / 1102 (6.26%)
    35 / 561 (6.24%)
    2 / 158 (1.27%)
    4 / 310 (1.29%)
    0 / 41 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    109
    77
    39
    2
    4
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    1 / 1671 (0.06%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    70 / 1671 (4.19%)
    59 / 1102 (5.35%)
    18 / 561 (3.21%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    85
    68
    20
    1
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    96 / 1671 (5.75%)
    58 / 1102 (5.26%)
    22 / 561 (3.92%)
    2 / 158 (1.27%)
    0 / 310 (0.00%)
    2 / 41 (4.88%)
    1 / 16 (6.25%)
         occurrences all number
    119
    70
    24
    2
    0
    2
    1
    Nasal congestion
         subjects affected / exposed
    58 / 1671 (3.47%)
    27 / 1102 (2.45%)
    13 / 561 (2.32%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    62
    33
    13
    1
    0
    0
    1
    Cough
         subjects affected / exposed
    144 / 1671 (8.62%)
    111 / 1102 (10.07%)
    25 / 561 (4.46%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    1 / 16 (6.25%)
         occurrences all number
    170
    135
    33
    0
    0
    1
    1
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    29 / 1671 (1.74%)
    23 / 1102 (2.09%)
    3 / 561 (0.53%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    29
    23
    3
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    39 / 1671 (2.33%)
    25 / 1102 (2.27%)
    14 / 561 (2.50%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    41
    26
    14
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    10 / 1671 (0.60%)
    11 / 1102 (1.00%)
    7 / 561 (1.25%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    11
    13
    9
    0
    1
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    17 / 1671 (1.02%)
    19 / 1102 (1.72%)
    9 / 561 (1.60%)
    0 / 158 (0.00%)
    2 / 310 (0.65%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    21
    21
    9
    0
    2
    1
    0
    Syncope
         subjects affected / exposed
    8 / 1671 (0.48%)
    3 / 1102 (0.27%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    9
    3
    2
    0
    0
    1
    0
    Migraine
         subjects affected / exposed
    5 / 1671 (0.30%)
    5 / 1102 (0.45%)
    5 / 561 (0.89%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    5
    6
    5
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    128 / 1671 (7.66%)
    83 / 1102 (7.53%)
    36 / 561 (6.42%)
    2 / 158 (1.27%)
    5 / 310 (1.61%)
    4 / 41 (9.76%)
    3 / 16 (18.75%)
         occurrences all number
    154
    97
    46
    2
    5
    4
    4
    Ear and labyrinth disorders
    Motion sickness
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    22 / 1671 (1.32%)
    8 / 1102 (0.73%)
    6 / 561 (1.07%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    22
    11
    10
    0
    0
    0
    1
    Food poisoning
         subjects affected / exposed
    4 / 1671 (0.24%)
    0 / 1102 (0.00%)
    3 / 561 (0.53%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    3
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    72 / 1671 (4.31%)
    53 / 1102 (4.81%)
    23 / 561 (4.10%)
    1 / 158 (0.63%)
    7 / 310 (2.26%)
    0 / 41 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    78
    65
    27
    1
    7
    0
    2
    Abdominal pain lower
         subjects affected / exposed
    5 / 1671 (0.30%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    5
    0
    1
    0
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    14 / 1671 (0.84%)
    10 / 1102 (0.91%)
    4 / 561 (0.71%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    2 / 41 (4.88%)
    0 / 16 (0.00%)
         occurrences all number
    14
    11
    4
    0
    0
    2
    0
    Nausea
         subjects affected / exposed
    54 / 1671 (3.23%)
    34 / 1102 (3.09%)
    17 / 561 (3.03%)
    1 / 158 (0.63%)
    3 / 310 (0.97%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    57
    35
    19
    1
    3
    1
    0
    Oral pain
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    34 / 1671 (2.03%)
    17 / 1102 (1.54%)
    11 / 561 (1.96%)
    1 / 158 (0.63%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    38
    17
    11
    1
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    3 / 310 (0.97%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    1
    0
    3
    1
    0
    Acne
         subjects affected / exposed
    1 / 1671 (0.06%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    1
    Dermatitis atopic
         subjects affected / exposed
    5 / 1671 (0.30%)
    1 / 1102 (0.09%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    1
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 1671 (0.00%)
    2 / 1102 (0.18%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    3 / 1671 (0.18%)
    1 / 1102 (0.09%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    4
    1
    2
    0
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    20 / 1671 (1.20%)
    25 / 1102 (2.27%)
    18 / 561 (3.21%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    20
    25
    20
    0
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    34 / 1671 (2.03%)
    22 / 1102 (2.00%)
    9 / 561 (1.60%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    39
    24
    10
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    37 / 1671 (2.21%)
    32 / 1102 (2.90%)
    17 / 561 (3.03%)
    0 / 158 (0.00%)
    2 / 310 (0.65%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    39
    36
    19
    0
    3
    1
    0
    Rheumatoid arthritis
         subjects affected / exposed
    24 / 1671 (1.44%)
    25 / 1102 (2.27%)
    12 / 561 (2.14%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    35
    33
    17
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    77 / 1671 (4.61%)
    41 / 1102 (3.72%)
    24 / 561 (4.28%)
    1 / 158 (0.63%)
    1 / 310 (0.32%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    85
    45
    27
    1
    1
    0
    0
    Influenza
         subjects affected / exposed
    37 / 1671 (2.21%)
    14 / 1102 (1.27%)
    8 / 561 (1.43%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    38
    14
    8
    0
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    3 / 1671 (0.18%)
    2 / 1102 (0.18%)
    2 / 561 (0.36%)
    0 / 158 (0.00%)
    1 / 310 (0.32%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    3
    2
    2
    0
    1
    1
    0
    Gastritis viral
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    17 / 1671 (1.02%)
    12 / 1102 (1.09%)
    3 / 561 (0.53%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    17
    12
    3
    0
    0
    1
    0
    COVID-19
         subjects affected / exposed
    273 / 1671 (16.34%)
    205 / 1102 (18.60%)
    112 / 561 (19.96%)
    4 / 158 (2.53%)
    3 / 310 (0.97%)
    1 / 41 (2.44%)
    1 / 16 (6.25%)
         occurrences all number
    293
    218
    116
    4
    3
    1
    1
    Bronchitis
         subjects affected / exposed
    49 / 1671 (2.93%)
    30 / 1102 (2.72%)
    7 / 561 (1.25%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    56
    33
    8
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 1671 (0.12%)
    0 / 1102 (0.00%)
    1 / 561 (0.18%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    41 / 1671 (2.45%)
    27 / 1102 (2.45%)
    10 / 561 (1.78%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    0 / 41 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    47
    32
    11
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    19 / 1671 (1.14%)
    11 / 1102 (1.00%)
    9 / 561 (1.60%)
    1 / 158 (0.63%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    3 / 16 (18.75%)
         occurrences all number
    25
    15
    10
    1
    0
    1
    5
    Urinary tract infection
         subjects affected / exposed
    87 / 1671 (5.21%)
    60 / 1102 (5.44%)
    27 / 561 (4.81%)
    1 / 158 (0.63%)
    3 / 310 (0.97%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    125
    85
    31
    1
    3
    1
    0
    Sinusitis
         subjects affected / exposed
    50 / 1671 (2.99%)
    34 / 1102 (3.09%)
    18 / 561 (3.21%)
    1 / 158 (0.63%)
    1 / 310 (0.32%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    62
    42
    21
    1
    1
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    121 / 1671 (7.24%)
    63 / 1102 (5.72%)
    44 / 561 (7.84%)
    0 / 158 (0.00%)
    3 / 310 (0.97%)
    5 / 41 (12.20%)
    0 / 16 (0.00%)
         occurrences all number
    150
    69
    50
    0
    3
    7
    0
    Ureaplasma infection
         subjects affected / exposed
    0 / 1671 (0.00%)
    0 / 1102 (0.00%)
    0 / 561 (0.00%)
    0 / 158 (0.00%)
    0 / 310 (0.00%)
    1 / 41 (2.44%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Feb 2023
    The agent under study was changed from the mAb combination (AZD5156) to only one of its component mAbs (AZD3152) due to variant evolution. (v5)
    24 May 2023
    The sub-study was added as addendum and efficacy was upgraded to primary endpoint. (v6)
    14 Jun 2023
    The comparator was changed from Evusheld to placebo. (v7)
    21 Dec 2023
    A 2nd (dual) primary endpoint added to the trial. (v8)

    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
    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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