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    Clinical Trial Results:
    A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age

    Summary
    EudraCT number
    		 2021-005026-20
    Trial protocol
    		 DE   FI   BE   ES   PL  
    Global end of trial date
    28 Jul 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Aug 2026
    First version publication date
    14 Aug 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    mRNA-1345-P301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05127434
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ModernaTX, Inc.
    Sponsor organisation address
    325 Binney Street, 325 Binney Street, United States, 02142
    Public contact
    Moderna WeCare Team, ModernaTX, Inc., +1 866-663-3762, WeCareClinicalTrials@modernatx.com
    Scientific contact
    Moderna WeCare Team, ModernaTX, Inc., +1 866-663-3762, WeCareClinicalTrials@modernatx.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
    28 Jul 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jul 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, and other applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 3589
    Country: Number of subjects enrolled
    Australia: 256
    Country: Number of subjects enrolled
    Bangladesh: 2421
    Country: Number of subjects enrolled
    Belgium: 413
    Country: Number of subjects enrolled
    Canada: 706
    Country: Number of subjects enrolled
    Chile: 679
    Country: Number of subjects enrolled
    Colombia: 2625
    Country: Number of subjects enrolled
    Costa Rica: 208
    Country: Number of subjects enrolled
    Finland: 96
    Country: Number of subjects enrolled
    Germany: 471
    Country: Number of subjects enrolled
    Japan: 822
    Country: Number of subjects enrolled
    Mexico: 733
    Country: Number of subjects enrolled
    New Zealand: 299
    Country: Number of subjects enrolled
    Panama: 1551
    Country: Number of subjects enrolled
    Poland: 346
    Country: Number of subjects enrolled
    Singapore: 8
    Country: Number of subjects enrolled
    South Africa: 982
    Country: Number of subjects enrolled
    Korea, Republic of: 301
    Country: Number of subjects enrolled
    Spain: 220
    Country: Number of subjects enrolled
    Taiwan: 84
    Country: Number of subjects enrolled
    United Kingdom: 450
    Country: Number of subjects enrolled
    United States: 19554
    Worldwide total number of subjects
    36814
    EEA total number of subjects
    1546
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12451
    From 65 to 84 years
    23598
    85 years and over
    765

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 36814 participants were randomized in Part A (18427 participants in the mRNA-1345 group and 18387 participants in the placebo group). A total of 1510 participants from Part A mRNA-1345 group were randomized into Part B substudy (1005 participants in the mRNA-1345 group and 505 in the placebo group).

    Period 1
    Period 1 title
    Part A
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: Placebo
    Arm description
    		 Participants received a single intramuscular (IM) injection of placebo on Day 1 in Part A.
    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
    Placebo matched to mRNA-1345 was administered per schedule specified in the arm description.

    Arm title
    		 Part A: mRNA-1345
    Arm description
    		 Participants received a single IM injection of mRNA-1345 on Day 1 in Part A.
    Arm type
    		 Experimental

    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
    mRNA-1345 was administered per schedule specified in the arm description.

    Number of subjects in period 1
    		Part A: Placebo Part A: mRNA-1345
    Started
    18387
    18427
    Safety Set
    18316
    18369
    Solicited Safety Set
    18102
    18174
    Per-protocol Efficacy (PPE) Set
    18120
    18164
    Completed
    15605
    15726
    Not completed
    2782
    2701
         Physician decision
    98
    81
         Consent withdrawn by subject
    922
    859
         Other Than Specified
    530
    537
         Non-Compliance with Study Drug
    2
    1
         Adverse event, non-fatal
    29
    20
         Death
    305
    300
         Lost to follow-up
    849
    871
         Protocol deviation
    47
    32
    Period 2
    Period 2 title
    Part B
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part B: Placebo
    Arm description
    		 Participants who received mRNA-1345 in Part A, received a single IM injection of booster dose (BD) of placebo on BD Day 1 in Part B.
    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
    Placebo matched to mRNA-1345 was administered per schedule specified in the arm description.

    Arm title
    		 Part B: mRNA-1345
    Arm description
    		 Participants who received mRNA-1345 in Part A, continued to receive a single IM injection of BD of mRNA-1345 on BD Day 1 in Part B.
    Arm type
    		 Experimental

    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
    mRNA-1345 was administered per schedule specified in the arm description.

    Number of subjects in period 2 [1]
    		Part B: Placebo Part B: mRNA-1345
    Started
    505
    1005
    Received Revaccination (BD) Injection
    504
    998
    Safety Set
    504
    998
    Solicited Safety Set
    503
    995
    Per-protocol (PP) Set
    489
    956
    Completed
    480
    954
    Not completed
    25
    51
         Consent withdrawn by subject
    3
    9
         Other Than Specified
    15
    30
         Death
    1
    -
         Lost to follow-up
    6
    12
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all participants from Part A were randomized into Part B.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: Placebo
    Reporting group description
    		 Participants received a single intramuscular (IM) injection of placebo on Day 1 in Part A.

    Reporting group title
    Part A: mRNA-1345
    Reporting group description
    		 Participants received a single IM injection of mRNA-1345 on Day 1 in Part A.

    Reporting group values
    		 Part A: Placebo Part A: mRNA-1345 Total
    Number of subjects
    		 18387 18427 36814
    Age Categorical
    Units: participants
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.5 ( 6.61 ) 68.5 ( 6.59 ) -
    Gender Categorical
    Units: participants
        Female
    		 9057 9017 18074
        Male
    		 9330 9410 18740
    Race
    Units: Subjects
        White
    		 11290 11311 22601
        Black or African American
    		 2173 2204 4377
        Asian
    		 2138 2151 4289
        American Indian or Alaska Native
    		 896 906 1802
        Native Hawaiian or Other Pacific Islander
    		 19 28 47
        Other
    		 1013 996 2009
        Multiple
    		 752 762 1514
        Unknown
    		 20 10 30
        Not Reported
    		 86 59 145
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 6168 6117 12285
        Not Hispanic or Latino
    		 12010 12124 24134
        Unknown
    		 22 27 49
        Not Reported
    		 187 159 346

    End points

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    End points reporting groups
    Reporting group title
    Part A: Placebo
    Reporting group description
    		 Participants received a single intramuscular (IM) injection of placebo on Day 1 in Part A.

    Reporting group title
    Part A: mRNA-1345
    Reporting group description
    		 Participants received a single IM injection of mRNA-1345 on Day 1 in Part A.
    Reporting group title
    Part B: Placebo
    Reporting group description
    		 Participants who received mRNA-1345 in Part A, received a single IM injection of booster dose (BD) of placebo on BD Day 1 in Part B.

    Reporting group title
    Part B: mRNA-1345
    Reporting group description
    		 Participants who received mRNA-1345 in Part A, continued to receive a single IM injection of BD of mRNA-1345 on BD Day 1 in Part B.

    Subject analysis set title
    mRNA-1345 Primary Vaccination
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received a single IM injection of mRNA-1345 (primary vaccination) on Day 1 in Part A.

    Subject analysis set title
    mRNA-1345 Revaccination
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received a single IM injection of BD (revaccination) of mRNA-1345 on BD Day 1 in Part B.

    Primary: Part A: Number of Participants with Solicited Adverse Reactions (ARs) (Solicited Local and/or Systemic ARs)

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    End point title
    		 Part A: Number of Participants with Solicited Adverse Reactions (ARs) (Solicited Local and/or Systemic ARs) [1]
    End point description
    Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. Part A Solicited Safety Set included all randomized participants who received the study intervention and who contributed any solicited AR data. Participants were included in the treatment group corresponding to the study vaccination that they actually received.
    End point type
    Primary
    End point timeframe
    Up to 7 days postinjection
    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: The endpoint is descriptive in nature.
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    18102
    18174
    Units: participants
    6975
    12383
    No statistical analyses for this end point

    Primary: Part B: Number of Participants with Solicited Local and Systemic ARs

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    End point title
    		 Part B: Number of Participants with Solicited Local and Systemic ARs [2]
    End point description
    Solicited ARs were recorded daily using electronic diaries (eDiaries). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. Part B Solicited Safety Set included all Part B randomized participants who received any study intervention and contributed any solicited AR data. Participants were included in the treatment group corresponding to the study vaccination that they actually received.
    End point type
    Primary
    End point timeframe
    Up to 7 days post-BD injection
    Notes
    [2] - 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: The endpoint is descriptive in nature.
    End point values
    		 Part B: Placebo Part B: mRNA-1345
    Number of subjects analysed
    503
    995
    Units: participants
    194
    748
    No statistical analyses for this end point

    Primary: Part A: Number of Participants with Unsolicited Adverse Events (AEs)

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    End point title
    		 Part A: Number of Participants with Unsolicited Adverse Events (AEs) [3]
    End point description
    An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. Part A Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment group corresponding to the study vaccination that they actually received.
    End point type
    Primary
    End point timeframe
    Up to 28 days postinjection
    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: The endpoint is descriptive in nature.
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    18316
    18369
    Units: participants
    3472
    3841
    No statistical analyses for this end point

    Primary: Part B: Number of Participants With MAAEs, AESIs, SAEs, and AEs Leading to Study Discontinuation

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    End point title
    		 Part B: Number of Participants With MAAEs, AESIs, SAEs, and AEs Leading to Study Discontinuation [4]
    End point description
    MAAEs were AEs that led to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor’s product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. Part B Safety Set included all Part B randomized participants who received any study intervention. Participants were included in the treatment group corresponding to the study vaccination that they actually received.
    End point type
    Primary
    End point timeframe
    Up to BD Day 181
    Notes
    [4] - 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: The endpoint is descriptive in nature.
    End point values
    		 Part B: Placebo Part B: mRNA-1345
    Number of subjects analysed
    504
    998
    Units: participants
        MAAEs
    131
    226
        AESIs
    3
    2
        SAEs
    26
    29
        AEs Leading to Study Discontinuation
    1
    0
    No statistical analyses for this end point

    Primary: Part B: Number of Participants with Unsolicited AEs

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    End point title
    		 Part B: Number of Participants with Unsolicited AEs [5]
    End point description
    An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. Part B Safety Set included all Part B randomized participants who received any study intervention. Participants were included in the treatment group corresponding to the study vaccination that they actually received.
    End point type
    Primary
    End point timeframe
    Up to 28 days post-BD injection
    Notes
    [5] - 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: The endpoint is descriptive in nature.
    End point values
    		 Part B: Placebo Part B: mRNA-1345
    Number of subjects analysed
    504
    998
    Units: participants
    75
    123
    No statistical analyses for this end point

    Primary: Part A: Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation

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    End point title
    		 Part A: Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation [6]
    End point description
    MAAEs were AEs that led to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor’s product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. Part A Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment group corresponding to the study vaccination that they actually received.
    End point type
    Primary
    End point timeframe
    Up to 24 months postinjection
    Notes
    [6] - 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: The endpoint is descriptive in nature.
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    18316
    18369
    Units: participants
        MAAEs
    10995
    11313
        AESIs
    154
    158
        SAEs
    2745
    2773
        AEs Leading to Study Discontinuation
    335
    319
    No statistical analyses for this end point

    Primary: Part A: Number of Participants With Respiratory Syncytial Virus- Associated Lower Respiratory Tract Disease (RSV-LRTD) With 2 or More Symptoms From 14 Days Postinjection up to 12 Months Postinjection

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    End point title
    		 Part A: Number of Participants With Respiratory Syncytial Virus- Associated Lower Respiratory Tract Disease (RSV-LRTD) With 2 or More Symptoms From 14 Days Postinjection up to 12 Months Postinjection
    End point description
    RSV-LRTD: Reverse transcriptase polymerase chain reaction (RT PCR) confirmed RSV infection PLUS new or worsening of ≥2 of the following symptoms: shortness of breath, cough and/or fever (≥37.8 degrees Celsius [°C]), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours. Part A PPE Set: all randomized participants who received assigned study intervention according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 14 days postinjection up to 12 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    17516
    17572
    Units: participants
    55
    9
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Vaccine efficacy (VE) of mRNA-1345 to prevent a first episode of RSV-LRTD with 2 or more symptoms within the period of 14 days postinjection up to 12 months post-injection was the primary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    35088
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Stratified Cox proportional hazard model
    Parameter type
    		 VE (%)
    Point estimate
    83.7
    Confidence interval
         level
    		 95.88%
         sides
    2-sided
         lower limit
    		 66
         upper limit
    		 92.2

    Primary: Part A: Number of Participants With RSV-LRTD With 3 or More Symptoms From 14 Days Postinjection up to 12 Months Postinjection

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    End point title
    		 Part A: Number of Participants With RSV-LRTD With 3 or More Symptoms From 14 Days Postinjection up to 12 Months Postinjection
    End point description
    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥3 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours. Part A PPE Set included all randomized participants who received assigned study intervention dose according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From 14 days postinjection up to 12 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    17516
    17572
    Units: participants
    17
    3
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    VE of mRNA-1345 to prevent a first episode of RSV-LRTD with 3 or more symptoms within the period of 14 days postinjection up to 12 months post-injection was the primary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    35088
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0078
    Method
    		 Stratified Cox proportional hazard model
    Parameter type
    		 VE (%)
    Point estimate
    82.4
    Confidence interval
         level
    		 96.36%
         sides
    2-sided
         lower limit
    		 34.8
         upper limit
    		 95.3

    Primary: Part B: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAb) at BD Day 29 Compared to Primary Dose Day 29

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    End point title
    		 Part B: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAb) at BD Day 29 Compared to Primary Dose Day 29
    End point description
    Antibody values reported as below lower limit of quantification (LLOQ) replaced by 0.5 * LLOQ. Values greater than upper limit of quantification (ULOQ) replaced by ULOQ. LLOQ = 13 international units (IU)/milliliter (mL), ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part B Per-protocol (PP) Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized. ‘Number analyzed’= participants evaluable for this endpoint. ‘n’ = participants evaluable for specified category.
    End point type
    Primary
    End point timeframe
    Primary Dose Day 29 and BD Day 29
    End point values
    		 mRNA-1345 Primary Vaccination mRNA-1345 Revaccination
    Number of subjects analysed
    955
    955
    Units: IU/mL
    geometric mean (confidence interval 95%)
        RSV-A (n=955,955)
    17157.48 (16004.77 to 18393.22)
    12339.87 (11538.56 to 13196.82)
        RSV-B (n=951,953)
    5665.14 (5294.89 to 6061.28)
    4005.79 (3771.68 to 4254.43)
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    GMR of RSV-B nAb GMT at revaccination Day 29 over RSV-B nAb GMT at Primary Dose Day 29 was the primary endpoint.
    Comparison groups
    mRNA-1345 Primary Vaccination v mRNA-1345 Revaccination
    Number of subjects included in analysis
    1910
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 GMR
    Point estimate
    0.705
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6671
         upper limit
    		 0.7444
    Notes
    [7] - Number of participants in the analysis = 948 (Number of participants with non-missing antibody data at Baseline [primary dose Day 1], primary dose Day 29 and BD Day 29). Noninferiority margin = lower bound of 95% CI for GMR >0.667 (1/1.5).
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Geometric Mean Ratio (GMR) of RSV-A nAb GMT at revaccination Day 29 over RSV-A nAb GMT at Primary Dose Day 29 was the primary endpoint.
    Comparison groups
    mRNA-1345 Primary Vaccination v mRNA-1345 Revaccination
    Number of subjects included in analysis
    1910
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 GMR
    Point estimate
    0.719
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.676
         upper limit
    		 0.764
    Notes
    [8] - Number of participants in the analysis = 954 (Number of participants with non-missing antibody data at Baseline [primary dose Day 1], primary dose Day 29 and BD Day 29). Noninferiority margin = lower bound of 95% CI for GMR >0.667 (1/1.5).

    Secondary: Part A: Number of Participants With RSV-Associated Acute Respiratory Disease (RSV-ARD) From 14 Days Postinjection up to 12 Months Postinjection

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    End point title
    		 Part A: Number of Participants With RSV-Associated Acute Respiratory Disease (RSV-ARD) From 14 Days Postinjection up to 12 Months Postinjection
    End point description
    RSV-ARD: RT-PCR-confirmed RSV infection and an acute symptomatic respiratory disease manifesting as new or worsening of 1 or more of cough, stuffy nose, runny nose, sore throat, fever (≥37.8°C), shortness of breath, observed tachypnea (≥20 breaths/minute or increase of ≥2 breaths/minute from baseline in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93%, or new or increasing use of supplemental oxygen), wheezing, sputum production, hoarseness, sinus pain, chills, pleuritic chest pain for at least 24 hours. Part A PPE Set: all randomized participants who received assigned study intervention dose, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 14 days postinjection up to 12 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    17516
    17572
    Units: participants
    82
    26
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    VE of mRNA-1345 to prevent a first episode of RSV-ARD within the period of 14 days post-injection up to 12 months post-injection was the secondary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    35088
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    68.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 50.9
         upper limit
    		 79.7

    Secondary: Part A: Number of Participants With All-Cause Hospitalizations From 14 Days Postinjection up to 12 Months Postinjection

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    End point title
    		 Part A: Number of Participants With All-Cause Hospitalizations From 14 Days Postinjection up to 12 Months Postinjection
    End point description
    An all-cause hospitalization was defined as any reported hospitalization which was collected as inpatient or prolongation of existing hospitalization in the electronic case report form (eCRF) AE form. Part A PPE Set: all randomized participants who received assigned study intervention dose according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    From 14 days postinjection up to 12 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    18120
    18164
    Units: participants
    1564
    1580
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    VE of mRNA-1345 to prevent all-cause hospitalizations within the period of 14 days post-injection up to 12 months post-injection was the secondary endpoint. VE was defined as 100% * (1 — ratio of model estimated hospitalization rates (mRNA-1345 vs. placebo).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    36284
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 8.5

    Secondary: Part A: Number of Participants With Hospitalization Associated with Protocol-defined RSV-ARD or RSV-LRTD From 14 Days Postinjection up to 12 Months Postinjection

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    End point title
    		 Part A: Number of Participants With Hospitalization Associated with Protocol-defined RSV-ARD or RSV-LRTD From 14 Days Postinjection up to 12 Months Postinjection
    End point description
    A case of first hospitalization associated with protocol-defined RSV-ARD or RSV-LRTD was defined if: (a) The investigator assessed that an event was a confirmed diagnosis of RSV-LRTD or RSV-ARD and that required inpatient or prolongation of existing hospitalization; (b) a protocol-defined RSV-LRTD/RSV-ARD occurred; (c) date of protocol-defined RSV-LRTD/RSV-ARD was within 14 days prior or during hospitalization. RSV-ARD defined in Endpoint #10 and RSV-LRTD defined in Endpoint #7 above. Part A PPE Set: all randomized participants who received assigned study intervention dose according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 14 days postinjection up to 12 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    18045
    18112
    Units: participants
    2
    0
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    VE of mRNA-1345 to prevent first hospitalization associated with RSV-ARD or RSV-LRTD within the period of 14 days post-injection up to 12 months post-injection was the secondary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    36157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    Parameter type
    		 VE (%)
    Point estimate
    100
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 100
    Notes
    [9] - Lower limit of 95% CI reported as 0 signifies data could not be calculated due to smaller number of participants with an event.

    Secondary: Part A: Number of Participants With RSV-LRTD With 2 or More Symptoms From 14 Days Postinjection up to 24 Months Postinjection

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    End point title
    		 Part A: Number of Participants With RSV-LRTD With 2 or More Symptoms From 14 Days Postinjection up to 24 Months Postinjection
    End point description
    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥2 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours. Part A PPE Set: all randomized participants who received assigned study intervention dose according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    From 14 days postinjection up to 24 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    18120
    18164
    Units: participants
    286
    161
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    VE of mRNA-1345 to prevent a first episode of RSV-LRTD with 2 or more symptoms within the period of 14 days post-injection up to 24 months post-injection was the secondary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    36284
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    44.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 32.4
         upper limit
    		 54.1

    Secondary: Part A: Number of Participants With RSV-LRTD With 3 or More Symptoms From 14 Days Postinjection up to 24 Months Postinjection

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    End point title
    		 Part A: Number of Participants With RSV-LRTD With 3 or More Symptoms From 14 Days Postinjection up to 24 Months Postinjection
    End point description
    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥3 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours. Part A PPE Set included all randomized participants who received assigned study intervention dose according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    From 14 days postinjection up to 24 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    18120
    18164
    Units: participants
    123
    61
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    VE of mRNA-1345 to prevent a first episode of RSV-LRTD with 3 or more symptoms within the period of 14 days post-injection up to 24 months post-injection was the secondary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    36284
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    50.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.2
         upper limit
    		 63.8

    Secondary: Part A: Number of Participants With All-Cause LRTD From 14 Days Postinjection up to 12 Months Postinjection

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    End point title
    		 Part A: Number of Participants With All-Cause LRTD From 14 Days Postinjection up to 12 Months Postinjection
    End point description
    All-cause LRTD: New or worsening of ≥2 of following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours with any or no RT-PCR result. All-cause LRTD was derived based on eligible LRTD symptoms onset within a respiratory illness episode. Part A PPE Set: all randomized participants who received assigned study intervention dose according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    From 14 days postinjection up to 12 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    18120
    18164
    Units: participants
    5806
    5762
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    VE of mRNA-1345 to prevent all-cause LRTD within the period of 14 days post-injection up to 12 months post-injection was the secondary endpoint. VE was defined as 100% * (1 — ratio of model estimated LRTD rates (mRNA-1345 vs. placebo).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    36284
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 5.2

    Secondary: Part A: Number of Participants With RSV-LRTD With 3 or More Symptoms by RSV Subtype A and RSV Subtype B From 14 Days Postinjection up to 12 Months Postinjection

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    End point title
    		 Part A: Number of Participants With RSV-LRTD With 3 or More Symptoms by RSV Subtype A and RSV Subtype B From 14 Days Postinjection up to 12 Months Postinjection
    End point description
    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥3 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours. Part A PPE Set included all randomized participants who received assigned study intervention dose according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 14 days postinjection up to 12 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    17516
    17572
    Units: participants
        RSV-A
    10
    1
        RSV-B
    7
    2
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    For RSV-B: VE of mRNA-1345 to prevent a first episode of RSV-LRTD with 3 or more symptoms within the period of 14 days post-injection up to 12 months post-injection was the secondary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    35088
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    71.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37
         upper limit
    		 94.1
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    For RSV-A: VE of mRNA-1345 to prevent a first episode of RSV-LRTD with 3 or more symptoms within the period of 14 days post-injection up to 12 months post-injection was the secondary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    35088
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    90
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22
         upper limit
    		 98.7

    Secondary: Part A: Number of Participants With RSV-LRTD With 2 or More Symptoms by RSV Subtype A and RSV Subtype B From 14 Days Postinjection up to 12 Months Postinjection

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    End point title
    		 Part A: Number of Participants With RSV-LRTD With 2 or More Symptoms by RSV Subtype A and RSV Subtype B From 14 Days Postinjection up to 12 Months Postinjection
    End point description
    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥2 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours. Part A PPE Set: all randomized participants who received assigned study intervention dose according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 14 days postinjection up to 12 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    17516
    17572
    Units: participants
        RSV-A
    36
    3
        RSV-B
    19
    6
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    For RSV-B: VE of mRNA-1345 to prevent a first episode of RSV-LRTD with 2 or more symptoms within the period of 14 days post-injection up to 12 months post-injection was the secondary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    35088
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    68.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.1
         upper limit
    		 87.4
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    For RSV-A: VE of mRNA-1345 to prevent a first episode of RSV-LRTD with 2 or more symptoms within the period of 14 days post-injection up to 12 months post-injection was the secondary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    35088
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    91.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 73
         upper limit
    		 97.4

    Secondary: Part A: Number of Participants with First Hospitalization Associated with Protocol-defined RSV-ARD or RSV-LRTD From 14 Days Postinjection up to 24 Months Postinjection

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    End point title
    		 Part A: Number of Participants with First Hospitalization Associated with Protocol-defined RSV-ARD or RSV-LRTD From 14 Days Postinjection up to 24 Months Postinjection
    End point description
    A case of first hospitalization associated with protocol-defined RSV-ARD or RSV-LRTD was defined as: (a) The investigator assessed that an event was a confirmed diagnosis of RSV-LRTD or RSV-ARD and that required inpatient or prolongation of existing hospitalization; (b) a protocol-defined RSV-LRTD/RSV-ARD occurred; (c) date of protocol-defined RSV-LRTD/RSV-ARD was within 14 days prior or during hospitalization. RSV-ARD defined in Endpoint #10 and RSV-LRTD defined in Endpoint #7 above. Part A PPE Set: all randomized participants who received assigned study intervention dose according to protocol, completed ≥1 visit or surveillance contact 14 days after study intervention administration, and had no major protocol deviations affecting the efficacy outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    From 14 days postinjection up to 24 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    18120
    18164
    Units: participants
    2
    1
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    VE of mRNA-1345 to prevent first hospitalization associated with RSV-ARD or RSV-LRTD within the period of 14 days post-injection up to 24 months post-injection was the secondary endpoint. VE was defined as 100% * (1−hazard ratio [mRNA-1345 vs placebo]).
    Comparison groups
    Part A: Placebo v Part A: mRNA-1345
    Number of subjects included in analysis
    36284
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 VE (%)
    Point estimate
    50.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -447.1
         upper limit
    		 95.5

    Secondary: Part A: GMT of Serum RSV nAb

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    End point title
    		 Part A: GMT of Serum RSV nAb
    End point description
    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 13 IU/mL, ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part A Per-protocol Immunogenicity (PPI) Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Days 29, 181, 365, and 730
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    341
    1534
    Units: IU/mL
    geometric mean (confidence interval 95%)
        RSV-A: Day 1 (n=341,1533)
    2403.59 (2137.23 to 2703.15)
    2559.03 (2421.48 to 2704.39)
        RSV-A: Day 29 (n=332,1513)
    2411.91 (2151.25 to 2704.16)
    21258.26 (20083.91 to 22501.27)
        RSV-A: Day 181 (n=316,1421)
    2114.80 (1874.89 to 2385.41)
    7094.40 (6688.56 to 7524.87)
        RSV-A: Day 365 (n=306,1362)
    2011.85 (1766.83 to 2290.85)
    4646.43 (4375.17 to 4934.51)
        RSV-A: Day 730 (n=274,1200)
    2259.10 (1922.61 to 2654.49)
    3920.00 (3680.66 to 4174.90)
        RSV-B: Day 1 (n=340,1534)
    1367.88 (1219.40 to 1534.43)
    1425.73 (1354.03 to 1501.22)
        RSV-B: Day 29 (n=332,1512)
    1308.32 (1163.27 to 1471.45)
    7224.01 (6845.63 to 7623.30)
        RSV-B: Day 181 (n=316,1421)
    1123.06 (1001.78 to 1259.02)
    2797.20 (2653.08 to 2949.16)
        RSV-B: Day 365 (n=306,1362)
    1087.30 (955.94 to 1236.71)
    1993.79 (1891.72 to 2101.37)
        RSV-B: Day 730 (n=274,1204)
    1174.89 (1022.03 to 1350.61)
    1816.21 (1713.20 to 1925.41)
    No statistical analyses for this end point

    Secondary: Part A: Change in Total Frailty Score From Baseline to 12 Months and 24 Months Postinjection, Using the Edmonton Frail Scale (EFS)

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    End point title
    		 Part A: Change in Total Frailty Score From Baseline to 12 Months and 24 Months Postinjection, Using the Edmonton Frail Scale (EFS)
    End point description
    The total frail score is the sum of individual scores from the 11 questions representing 9 domains included in EFS, which is a multidimensional frail assessment scale that assesses domains related to frailty including cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. The total frail score ranges between 0 and 17. Higher scores suggest more frailty, and the total frail score can be interpreted as: 0-3=fit, 4-5=vulnerable, 6-7=mild frail, 8-9=moderate frail, 10 or more=severe frail. Part A PPE Set as defined in previous endpoint. 'Number analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 months and 24 months postinjection
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    15703
    15807
    Units: score on a scale
    arithmetic mean (standard deviation)
        Change at Month 12 (n=15703,15807)
    0.2 ( 1.79 )
    0.2 ( 1.78 )
        Change at Month 24 (n=14577,14680)
    0.3 ( 1.91 )
    0.3 ( 1.89 )
    No statistical analyses for this end point

    Secondary: Part A: Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies

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    End point title
    		 Part A: Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies
    End point description
    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 35 arbitrary unit (AU)/mL, ULOQ = 580553 AU/mL for RSV Pre-F immunoglobulin G (IgG) antibody (Ab). LLOQ = 57, ULOQ = 847551 for RSV Post-F IgG Ab. Part A PPI Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Days 29, 181, 365, and 730
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    341
    1535
    Units: AU/mL
    geometric mean (confidence interval 95%)
        RSV Pre-F IgG: Day 1 (n=341,1535)
    10197.91 (9390.41 to 11074.85)
    10719.10 (10305.60 to 11149.19)
        RSV Pre-F IgG: Day 29 (n=333,1513)
    10068.44 (9267.14 to 10939.01)
    81897.81 (78658.16 to 85270.89)
        RSV Pre-F IgG: Day 181 (n=316,1423)
    11559.45 (10640.29 to 12558.00)
    36208.22 (34870.87 to 37596.87)
        RSV Pre-F IgG: Day 365 (n=306,1362)
    11986.87 (10920.62 to 13157.22)
    26033.56 (25079.43 to 27023.99)
        RSV Pre-F IgG: Day 730 (n=274,1204)
    12673.59 (11359.94 to 14139.14)
    22428.74 (21513.33 to 23383.10)
        RSV Post-F IgG: Day 1 (n=341,1535)
    14188.99 (12866.04 to 15647.97)
    14405.86 (13767.81 to 15073.48)
        RSV Post-F IgG: Day 29 (n=333,1513)
    14054.35 (12744.65 to 15498.65)
    84081.63 (80191.52 to 88160.45)
        RSV Post-F IgG: Day 181 (n=316,1423)
    14335.77 (12948.78 to 15871.34)
    36078.03 (34477.82 to 37752.51)
        RSV Post-F IgG: Day 365 (n=306,1362)
    14957.00 (13401.73 to 16692.77)
    26977.85 (25796.45 to 28213.36)
        RSV Post-F IgG: Day 730 (n=274,1204)
    15681.64 (13810.96 to 17805.70)
    24413.11 (23258.27 to 25625.30)
    No statistical analyses for this end point

    Secondary: Part A: Percentage of Participants With Seroresponse in RSV nAb

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    End point title
    		 Part A: Percentage of Participants With Seroresponse in RSV nAb
    End point description
    Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ. Part A PPI Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Days 29, 181, 365, and 730
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    332
    1510
    Units: percentage of participants
    number (confidence interval 95%)
        RSV-A: Day 29 (n=332,1510)
    0.6 (0.1 to 2.2)
    74.0 (71.7 to 76.2)
        RSV-A: Day 181 (n=316,1418)
    3.2 (1.5 to 5.7)
    32.9 (30.4 to 35.4)
        RSV-A: Day 365 (n=306,1359)
    5.2 (3.0 to 8.4)
    19.3 (17.2 to 21.5)
        RSV-A: Day 730 (n=274,1197)
    7.7 (4.8 to 11.5)
    15.7 (13.7 to 17.9)
        RSV-B: Day 29 (n=332,1510)
    1.5 (0.5 to 3.5)
    56.6 (54.0 to 59.1)
        RSV-B: Day 181 (n=315,1419)
    3.2 (1.5 to 5.8)
    19.9 (17.8 to 22.0)
        RSV-B: Day 365 (n=305,1360)
    4.9 (2.8 to 8.0)
    10.5 (8.9 to 12.3)
        RSV-B: Day 730 (n=274,1202)
    6.9 (4.2 to 10.6)
    9.2 (7.6 to 10.9)
    No statistical analyses for this end point

    Secondary: Part A: Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers

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    End point title
    		 Part A: Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers
    End point description
    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 13 IU/mL, ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part A PPI Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Days 29, 181, 365, and 730
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    332
    1510
    Units: ratio
    geometric mean (confidence interval 95%)
        RSV-A: Day 29 (n=332,1510)
    1.00 (0.95 to 1.06)
    8.33 (7.88 to 8.80)
        RSV-A: Day 181 (n=316,1418)
    0.88 (0.81 to 0.94)
    2.80 (2.65 to 2.96)
        RSV-A: Day 365 (n=306,1359)
    0.84 (0.77 to 0.92)
    1.82 (1.73 to 1.92)
        RSV-A: Day 730 (n=274,1197)
    0.94 (0.84 to 1.04)
    1.60 (1.51 to 1.69)
        RSV-B: Day 29 (n=332,1510)
    0.96 (0.91 to 1.03)
    5.10 (4.86 to 5.36)
        RSV-B: Day 181 (n=315,1419)
    0.83 (0.77 to 0.89)
    1.98 (1.89 to 2.08)
        RSV-B: Day 365 (n=305,1360)
    0.80 (0.73 to 0.88)
    1.41 (1.35 to 1.48)
        RSV-B: Day 730 (n=274,1202)
    0.86 (0.76 to 0.97)
    1.32 (1.26 to 1.39)
    No statistical analyses for this end point

    Secondary: Part A: Percentage of Participants with ≥2-fold Increases in Antibody Titers from Baseline

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    End point title
    		 Part A: Percentage of Participants with ≥2-fold Increases in Antibody Titers from Baseline
    End point description
    A ≥2-fold increase from baseline was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. Part A PPI Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the vaccination group to which they were randomized. 'Number analyzed' = participants evaluable for this endpoint. 'n' = participants evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Days 29, 181, 365, and 730
    End point values
    		 Part A: Placebo Part A: mRNA-1345
    Number of subjects analysed
    332
    1510
    Units: percentage of participants
    number (confidence interval 95%)
        RSV-A: Day 29 (n=332,1510)
    4.5 (2.6 to 7.3)
    91.1 (89.6 to 92.5)
        RSV-A: Day 181 (n=316,1418)
    7.9 (5.2 to 11.5)
    60.9 (58.3 to 63.4)
        RSV-A: Day 365 (n=306,1359)
    10.5 (7.3 to 14.4)
    42.7 (40.0 to 45.4)
        RSV-A: Day 730 (n=274,1197)
    13.5 (9.7 to 18.1)
    35.2 (32.5 to 38.0)
        RSV-B: Day 29 (n=332,1510)
    5.4 (3.2 to 8.4)
    84.2 (82.2 to 86.0)
        RSV-B: Day 181 (n=315,1419)
    8.9 (6.0 to 12.6)
    46.7 (44.0 to 49.3)
        RSV-B: Day 365 (n=305,1360)
    9.2 (6.2 to 13.0)
    29.6 (27.1 to 32.1)
        RSV-B: Day 730 (n=274,1202)
    15.7 (11.6 to 20.6)
    27.6 (25.1 to 30.2)
    No statistical analyses for this end point

    Secondary: Part B: GMT of Serum RSV-A and RSV-B nAb at BD Day 1 and BD Day 181

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    End point title
    		 Part B: GMT of Serum RSV-A and RSV-B nAb at BD Day 1 and BD Day 181
    End point description
    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 13 IU/mL, ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part B PP Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized. ‘Number analyzed’= participants evaluable for this endpoint. ‘n’ = participants evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    BD Day 1 and BD Day 181
    End point values
    		 Part B: Placebo Part B: mRNA-1345
    Number of subjects analysed
    489
    954
    Units: IU/mL
    geometric mean (confidence interval 95%)
        RSV-A: BD Day 1 (n=489,954)
    3533.60 (3212.07 to 3887.31)
    4186.08 (3899.52 to 4493.69)
        RSV-A: BD Day 181 (n=465,902)
    3156.10 (2846.53 to 3499.35)
    6256.67 (5818.27 to 6728.10)
        RSV-B: BD Day 1 (n=489,954)
    1636.66 (1504.60 to 1780.31)
    1626.56 (1529.35 to 1729.95)
        RSV-B: BD Day 181 (n=465,902)
    1495.45 (1366.74 to 1636.27)
    2269.18 (2133.63 to 2413.34)
    No statistical analyses for this end point

    Secondary: Part B: Percentage of Participants With Seroresponse of Serum RSV-A and RSV-B nAb at BD Day 29 Compared to Primary Dose Day 29

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    End point title
    		 Part B: Percentage of Participants With Seroresponse of Serum RSV-A and RSV-B nAb at BD Day 29 Compared to Primary Dose Day 29
    End point description
    Seroresponse was defined as a post-primary dose or post-revaccination titer ≥4 * LLOQ if Baseline was <LLOQ or a ≥4-fold increase from baseline if baseline was ≥LLOQ. Part B PP Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized. ‘Number analyzed’= participants evaluable for this endpoint. ‘n’ = participants evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Primary Dose Day 29 and BD Day 29
    End point values
    		 mRNA-1345 Primary Vaccination mRNA-1345 Revaccination
    Number of subjects analysed
    955
    955
    Units: percentage of participants
    number (confidence interval 95%)
        RSV-A (n=955,955)
    73.3 (70.4 to 76.1)
    66.0 (62.9 to 69.0)
        RSV-B (n=951,953)
    57.9 (54.7 to 61.1)
    46.0 (42.8 to 49.2)
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    SRR difference of RSV-B nAb SRR at revaccination Day 29 over RSV-A nAb SRR at Primary Dose Day 29 was the secondary endpoint.
    Comparison groups
    mRNA-1345 Primary Vaccination v mRNA-1345 Revaccination
    Number of subjects included in analysis
    1910
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 SRR Difference
    Point estimate
    -12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.4
         upper limit
    		 -8.9
    Notes
    [10] - Number of participants in the analysis = 948 (Number of participants with non-missing antibody data at Baseline [primary dose Day 1], primary dose Day 29 and BD Day 29). Noninferiority margin = lower bound of 95% CI for SRR >10%.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Seroresponse Rate (SRR) difference of RSV-A nAb SRR at revaccination Day 29 over RSV-A nAb SRR at Primary Dose Day 29 was the secondary endpoint.
    Comparison groups
    mRNA-1345 Primary Vaccination v mRNA-1345 Revaccination
    Number of subjects included in analysis
    1910
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 SRR Difference
    Point estimate
    -7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 -4.3
    Notes
    [11] - Number of participants in the analysis = 954 (Number of participants with non-missing antibody data at Baseline [primary dose Day 1], primary dose Day 29 and BD Day 29). Noninferiority margin = lower bound of 95% CI for SRR >10%.

    Secondary: Part B: GMFR of Serum RSV-A and RSV-B NAb from Pre-primary Dose (Baseline)

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    End point title
    		 Part B: GMFR of Serum RSV-A and RSV-B NAb from Pre-primary Dose (Baseline)
    End point description
    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 13 IU/mL, ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part B PP Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized. ‘Number analyzed’= participants evaluable for this endpoint. ‘n’ = participants evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    BD Day 1, BD Day 29, and BD Day 181
    End point values
    		 Part B: Placebo Part B: mRNA-1345
    Number of subjects analysed
    489
    955
    Units: ratio
    geometric mean (confidence interval 95%)
        RSV-A: BD Day 1 (n=489,954)
    1.73 (1.58 to 1.88)
    2.04 (1.91 to 2.18)
        RSV-A: BD Day 29 (n=488,955)
    1.74 (1.59 to 1.91)
    6.01 (5.57 to 6.50)
        RSV-A: BD Day 181 (n=465,902)
    1.58 (1.44 to 1.73)
    3.05 (2.84 to 3.27)
        RSV-B: BD Day 1 (n=489,954)
    1.31 (1.22 to 1.41)
    1.46 (1.38 to 1.54)
        RSV-B: BD Day 29 (n=489,953)
    1.24 (1.16 to 1.33)
    3.59 (3.36 to 3.84)
        RSV-B: BD Day 181 (n=465,902)
    1.22 (1.13 to 1.31)
    2.02 (1.90 to 2.15)
    No statistical analyses for this end point

    Secondary: Part B: Percentage of Participants With Seroresponse of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)

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    End point title
    		 Part B: Percentage of Participants With Seroresponse of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)
    End point description
    Seroresponse was defined as a post-primary dose or post-revaccination titer ≥4 * LLOQ if Baseline was <LLOQ or a ≥4-fold increase from baseline if baseline was ≥LLOQ. Part B PP Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized. ‘Number analyzed’= participants evaluable for this endpoint. ‘n’ = participants evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    BD Day 1, BD Day 29, and BD Day 181
    End point values
    		 Part B: Placebo Part B: mRNA-1345
    Number of subjects analysed
    489
    955
    Units: percentage of participants
    number (confidence interval 95%)
        RSV-A: BD Day 1 (n=489,954)
    18.8 (15.5 to 22.6)
    22.6 (20.0 to 25.4)
        RSV-A: BD Day 29 (n=488,955)
    18.2 (14.9 to 22.0)
    66.0 (62.9 to 69.0)
        RSV-A: BD Day 181 (n=468,902)
    15.7 (12.5 to 19.3)
    39.4 (36.2 to 42.6)
        RSV-B: BD Day 1 (n=489,954)
    6.7 (4.7 to 9.4)
    9.6 (7.8 to 11.7)
        RSV-B: BD Day 29 (n=489,953)
    6.7 (4.7 to 9.4)
    46.0 (42.8 to 49.2)
        RSV-B: BD Day 181 (n=465,902)
    7.5 (5.3 to 10.3)
    20.3 (17.7 to 23.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Deaths, SAEs, AESIs, MAAEs, and AEs led to study discontinuation: up to Month 24 (Part A) and up to BD Day 181 (Part B). Non-serious AEs: up to 28 days after study injection, unless they met criteria for AESIs, MAAEs, or AEs led to study discontinuation.
    Adverse event reporting additional description
    Part A Safety Set: randomized participants who received any study drug. Part B Safety Set: Part B randomized participants who received any study drug. Participants included in study arms corresponding to study drug actually received. ‘Deaths’ as reason for study discontinuation reported in subject disposition; ‘all deaths’ reported in AE section.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Part A: Placebo
    Reporting group description
    		 Participants received a single IM injection of placebo on Day 1 in Part A

    Reporting group title
    Part B: mRNA-1345
    Reporting group description
    		 Participants received a single IM injection of BD (revaccination) of mRNA-1345 on BD Day 1 in Part B.

    Reporting group title
    Part B: Placebo
    Reporting group description
    		 Participants received a single IM injection of BD of placebo on BD Day 1 in Part B.

    Reporting group title
    Part A: mRNA-1345
    Reporting group description
    		 Participants received a single IM injection of mRNA-1345 (primary vaccination) on Day 1 in Part A.

    Serious adverse events
    		 Part A: Placebo Part B: mRNA-1345 Part B: Placebo Part A: mRNA-1345
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2745 / 18316 (14.99%)
    29 / 998 (2.91%)
    26 / 504 (5.16%)
    2773 / 18369 (15.10%)
         number of deaths (all causes)
    307
    0
    1
    301
         number of deaths resulting from adverse events
    307
    0
    1
    301
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Adenocarcinoma metastatic
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    B-cell small lymphocytic lymphoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal squamous cell carcinoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaplastic thyroid cancer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma stage IV
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenocortical carcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    14 / 18316 (0.08%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    13 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 0
    0 / 0
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basosquamous carcinoma of skin
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign bone neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign gastrointestinal neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign renal neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of ampulla of Vater
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign pericardium neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign mediastinal neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer stage IV
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm benign
         subjects affected / exposed
    0 / 18316 (0.00%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain cancer metastatic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder squamous cell carcinoma stage unspecified
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    13 / 18316 (0.07%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 0
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer in situ
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Breast cancer stage I
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac neoplasm unspecified
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cancer pain
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carcinoid tumour of the stomach
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carcinoid tumour pulmonary
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carcinoma in situ of skin
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system lymphoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma stage II
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cholesteatoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer stage III
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Colon cancer metastatic
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer stage 0
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer stage II
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cutaneous T-cell lymphoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Elastofibroma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer stage I
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epithelioid mesothelioma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenoma
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial sarcoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extranodal marginal zone B-cell lymphoma (MALT type)
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fallopian tube cancer stage III
         subjects affected / exposed
    0 / 18316 (0.00%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Follicular lymphoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    Gastric cancer stage 0
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal lymphoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genitourinary tract neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Haemangioma of bone
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma of liver
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Hepatic cancer metastatic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Hepatocellular carcinoma
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Hodgkin's disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hormone receptor positive HER2 negative breast cancer
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Intraductal papillary breast neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    14 / 18369 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kaposi's sarcoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive papillary breast carcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Linitis plastica
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lip and/or oral cavity cancer
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liposarcoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage I
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Lung carcinoma cell type unspecified recurrent
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lobular breast carcinoma in situ
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Lung neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    12 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
    Lymphocytic leukaemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma stage I
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant ascites
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Malignant genitourinary tract neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant glioma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant peritoneal neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Mediastinum neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melanocytic naevus
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metaplastic breast carcinoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to abdominal cavity
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myeloproliferative neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Mucoepidermoid carcinoma of salivary gland
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelofibrosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic renal cell carcinoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal sinus cancer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Neuroblastoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine carcinoma metastatic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma stage IV
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nodular melanoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral haemangioma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    3 / 18316 (0.02%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer recurrent
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    Ovarian adenoma
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Papillary renal cell carcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Plasma cell myeloma in remission
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleomorphic adenoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    56 / 18316 (0.31%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    52 / 18369 (0.28%)
         occurrences causally related to treatment / all
    0 / 56
    0 / 0
    0 / 0
    0 / 54
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pituitary tumour benign
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Rectal cancer
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    3 / 18316 (0.02%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer stage IV
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer stage IV
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer stage I
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer stage II
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland cancer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine carcinoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sarcoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell carcinoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine neuroendocrine tumour
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of pharynx
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the parotid gland
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 18316 (0.01%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    T-cell lymphoma stage IV
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Testicular seminoma (pure)
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Waldenstrom's macroglobulinaemia
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal neoplasm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aneurysm thrombosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    14 / 18316 (0.08%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic thrombosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Aortic intramural haematoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic occlusion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    12 / 18316 (0.07%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial disorder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Giant cell arteritis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral artery embolism
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Distributive shock
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    23 / 18369 (0.13%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    1 / 1
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Circulatory collapse
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
    Arterial rupture
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Lymphoedema
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive end-organ damage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    19 / 18316 (0.10%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    15 / 18369 (0.08%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 0
    0 / 0
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    29 / 18316 (0.16%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    44 / 18369 (0.24%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 1
    0 / 0
    0 / 47
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    14 / 18316 (0.08%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    22 / 18369 (0.12%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 1
    0 / 0
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    18 / 18369 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
    0 / 0
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurogenic shock
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subclavian vein thrombosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superficial vein thrombosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subclavian steal syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vein rupture
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse event
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adverse drug reaction
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    4 / 18316 (0.02%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cardiac complication associated with device
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    37 / 18316 (0.20%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    37 / 18369 (0.20%)
         occurrences causally related to treatment / all
    0 / 37
    0 / 0
    0 / 1
    0 / 37
         deaths causally related to treatment / all
    0 / 37
    0 / 0
    0 / 1
    0 / 37
    Dehiscence
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    13 / 18316 (0.07%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    16 / 18369 (0.09%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 1
    0 / 0
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gait inability
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body reaction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye complication associated with device
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Granuloma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 4
    Pain
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Organ failure
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Oedema peripheral
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Sudden cardiac death
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 4
    Strangulated hernia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stent-graft endoleak
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical failure
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Unevaluable event
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Withdrawal syndrome
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactoid reaction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anti-neutrophil cytoplasmic antibody positive vasculitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Secondary immunodeficiency
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contrast media allergy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Organ donor
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adnexa uteri mass
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Balanoposthitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    32 / 18316 (0.17%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    29 / 18369 (0.16%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 0
    0 / 0
    0 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genital haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast enlargement
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genital prolapse
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gynaecomastia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic organ prolapse
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic pain
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular mass
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic obstruction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urogenital prolapse
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine adhesions
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterovaginal prolapse
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    44 / 18316 (0.24%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    35 / 18369 (0.19%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 0
    0 / 0
    0 / 36
         deaths causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 4
    Aspiration
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    15 / 18316 (0.08%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    15 / 18369 (0.08%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 0
    0 / 1
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma-chronic obstructive pulmonary disease overlap syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chylothorax
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    21 / 18316 (0.11%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 0
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    94 / 18316 (0.51%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    111 / 18369 (0.60%)
         occurrences causally related to treatment / all
    0 / 117
    0 / 0
    0 / 0
    0 / 142
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 6
    Organising pneumonia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung consolidation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mediastinal mass
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal swelling
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    8 / 18316 (0.04%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    17 / 18369 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
    0 / 0
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural fibrosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    31 / 18316 (0.17%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    33 / 18369 (0.18%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 0
    1 / 1
    0 / 33
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Pneumomediastinum
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis aspiration
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pulmonary hypertension
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary thrombosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Respiratory disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    19 / 18316 (0.10%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    23 / 18369 (0.13%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 1
    0 / 0
    0 / 24
         deaths causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 7
    Respiratory symptom
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus polyp
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord atrophy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute stress disorder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol use disorder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Compulsive sexual behaviour
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delusion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised anxiety disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Homicidal ideation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Depression
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance use disorder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizoaffective disorder depressive type
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device loosening
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device extrusion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device capturing issue
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device power source issue
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary obstruction
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholic liver disease
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic hepatic failure
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    30 / 18316 (0.16%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    32 / 18369 (0.17%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 0
    0 / 0
    0 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    18 / 18316 (0.10%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    16 / 18369 (0.09%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 1
    0 / 0
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    20 / 18316 (0.11%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    16 / 18369 (0.09%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 0
    0 / 0
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis sclerosing
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congestive hepatopathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder rupture
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic calcification
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic fibrosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic haematoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic lesion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic mass
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Hepatic steatosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Primary biliary cholangitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perforation bile duct
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine abnormal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood potassium abnormal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enzyme level abnormal
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug level decreased
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stoma output increased
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Occult blood
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urine output decreased
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accident
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    12 / 18316 (0.07%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    17 / 18369 (0.09%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
    0 / 0
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula maturation failure
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bite
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Avulsion fracture
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Carbon monoxide poisoning
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral hyperperfusion syndrome
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract operation complication
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central cord syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac procedure complication
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cervical vertebral fracture
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Costal cartilage fracture
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complications of bone marrow transplant
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complicated fracture
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    16 / 18369 (0.09%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Ear injury
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exposure to extreme temperature
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Face injury
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye contusion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    16 / 18316 (0.09%)
    1 / 998 (0.10%)
    1 / 504 (0.20%)
    25 / 18369 (0.14%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 1
    0 / 1
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    3 / 18316 (0.02%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flail chest
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    28 / 18316 (0.15%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    27 / 18369 (0.15%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 0
    0 / 0
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body ingestion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Fractured coccyx
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Heat exhaustion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated incisional hernia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    28 / 18316 (0.15%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    24 / 18369 (0.13%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 0
    0 / 0
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    15 / 18316 (0.08%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Heat stroke
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incision site haematoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incision site impaired healing
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 18316 (0.01%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Incomplete spinal fusion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament injury
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open fracture
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck injury
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 1
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Petroleum distillate poisoning
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteophyte fracture
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Patella fracture
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perineal injury
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital haematoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post concussion syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic pain
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal injury
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post laminectomy syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Post procedural fever
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural hypotension
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural stroke
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radiation oesophagitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    16 / 18316 (0.09%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    14 / 18369 (0.08%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 0
    0 / 0
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory fume inhalation disorder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
    Sciatic nerve injury
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress fracture
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    13 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Splenic rupture
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    4 / 18316 (0.02%)
    1 / 998 (0.10%)
    1 / 504 (0.20%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic lung injury
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    2 / 18316 (0.01%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral injury
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal injury
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bicuspid aortic valve
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Corneal dystrophy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermoid cyst
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fabry's disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital cystic kidney disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myotonic dystrophy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    14 / 18316 (0.08%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    12 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 0
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    Acute left ventricular failure
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    73 / 18316 (0.40%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    85 / 18369 (0.46%)
         occurrences causally related to treatment / all
    0 / 75
    0 / 0
    0 / 0
    0 / 93
         deaths causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 11
    Angina pectoris
         subjects affected / exposed
    20 / 18316 (0.11%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    30 / 18369 (0.16%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 1
    0 / 0
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    83 / 18316 (0.45%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    80 / 18369 (0.44%)
         occurrences causally related to treatment / all
    0 / 92
    0 / 0
    0 / 0
    0 / 87
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    Aortic valve stenosis
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve calcification
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    23 / 18316 (0.13%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    17 / 18369 (0.09%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 0
    0 / 0
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    10 / 18316 (0.05%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    12 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 1
    0 / 0
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    66 / 18316 (0.36%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    58 / 18369 (0.32%)
         occurrences causally related to treatment / all
    0 / 69
    0 / 1
    0 / 0
    0 / 58
         deaths causally related to treatment / all
    0 / 64
    0 / 0
    0 / 0
    0 / 51
    Bundle branch block right
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    12 / 18316 (0.07%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    13 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
    0 / 0
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    14 / 18316 (0.08%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular dissociation
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac perfusion defect
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    17 / 18316 (0.09%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 14
    0 / 0
    0 / 0
    0 / 9
    Cardiogenic shock
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    Cardiomyopathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 11
    Cardiac failure
         subjects affected / exposed
    26 / 18316 (0.14%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    34 / 18369 (0.19%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 0
    0 / 0
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 7
    Cardiac failure acute
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    48 / 18316 (0.26%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    34 / 18369 (0.19%)
         occurrences causally related to treatment / all
    0 / 52
    0 / 2
    0 / 0
    0 / 39
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    Cardiovascular disorder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Chronic left ventricular failure
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    62 / 18316 (0.34%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    60 / 18369 (0.33%)
         occurrences causally related to treatment / all
    0 / 67
    0 / 1
    0 / 0
    0 / 64
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Hypertensive cardiomyopathy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 18316 (0.01%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Degenerative aortic valve disease
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve disease
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nodal arrhythmia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    52 / 18316 (0.28%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    53 / 18369 (0.29%)
         occurrences causally related to treatment / all
    0 / 54
    0 / 0
    0 / 0
    0 / 53
         deaths causally related to treatment / all
    0 / 18
    0 / 0
    0 / 0
    0 / 14
    Myocardial ischaemia
         subjects affected / exposed
    17 / 18316 (0.09%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    18 / 18369 (0.10%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 0
    0 / 0
    0 / 20
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    Myocarditis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis constrictive
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus arrhythmia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatic heart disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Silent myocardial infarction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia paroxysmal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachyarrhythmia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholic seizure
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amnesia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arachnoiditis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basilar artery aneurysm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bell's palsy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    Brain oedema
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery aneurysm
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system lesion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    50 / 18316 (0.27%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    39 / 18369 (0.21%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 0
    0 / 0
    0 / 42
         deaths causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 4
    Cerebral haemorrhage
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cerebral infarction
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    14 / 18369 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 14
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Diabetic coma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical cord compression
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Essential tremor
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic cerebral infarction
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
    Headache
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune effector cell-associated neurotoxicity syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Intracranial mass
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    Intraventricular haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    IIIrd nerve paralysis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    52 / 18316 (0.28%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    46 / 18369 (0.25%)
         occurrences causally related to treatment / all
    0 / 52
    0 / 0
    0 / 0
    0 / 47
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
    IVth nerve paralysis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meralgia paraesthetica
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Morton's neuralgia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Motor dysfunction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Motor neurone disease
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple system atrophy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle spasticity
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Primary progressive aphasia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paralysis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Petit mal epilepsy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudostroke
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychogenic seizure
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Simple partial seizures
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    13 / 18369 (0.07%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 0
    0 / 0
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord infarction
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal meningeal cyst
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stroke
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    52 / 18316 (0.28%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    43 / 18369 (0.23%)
         occurrences causally related to treatment / all
    0 / 56
    0 / 0
    0 / 1
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Temporal lobe epilepsy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Thoracic radiculopathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasogenic cerebral oedema
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Unresponsive to stimuli
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    24 / 18316 (0.13%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    26 / 18369 (0.14%)
         occurrences causally related to treatment / all
    1 / 24
    0 / 0
    0 / 0
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebral artery dissection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar stroke
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord paralysis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
    Additional description: One event of facial paralysis assessed related to study drug by investigator; assessed not related by Sponsor due to participant’s medical history and later developments suggesting another explanation for event.
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
    Additional description: Incidence of Guillain-Barre syndrome was balanced between groups, none of the events occurred <500 days following study injection and none were assessed as related to the study vaccine.
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    25 / 18316 (0.14%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    38 / 18369 (0.21%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 0
    0 / 0
    0 / 40
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Methaemoglobinaemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    12 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spontaneous haematoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenomegaly
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normochromic anaemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    13 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conjunctival cyst
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corneal leukoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amaurosis fugax
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angle closure glaucoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corneal thinning
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ectropion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine ophthalmopathy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiretinal membrane
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Keratoconus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lens dislocation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metamorphopsia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neovascular age-related macular degeneration
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ocular vascular disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open angle glaucoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    3 / 18316 (0.02%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic neuropathy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pterygium
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal degeneration
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic atrophy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinopathy hypertensive
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia obstructive
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal fat apron
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia perforation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal incarcerated hernia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal mass
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal rigidity
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acid peptic disease
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholic pancreatitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cannabinoid hyperemesis syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastrointestinal bleeding
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coeliac disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis microscopic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon dysplasia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal obstruction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic hernia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic hernia, obstructive
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysbiosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral hernia strangulated
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flatulence
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric stenosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric volvulus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal fistula
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    8 / 18316 (0.04%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    12 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
    0 / 0
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glossitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoperitoneum
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileal perforation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 18316 (0.00%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    24 / 18316 (0.13%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    23 / 18369 (0.13%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 0
    0 / 0
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia perforation
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal cyst
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    21 / 18316 (0.11%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    25 / 18369 (0.14%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 0
    0 / 0
    0 / 27
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    Intestinal ischaemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal haematoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar hernia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Odynophagia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal food impaction
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal perforation
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic disorder
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatolithiasis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pancreatitis necrotising
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pancreatitis
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Proctitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal adhesions
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer perforation
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland cyst
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    12 / 18316 (0.07%)
    1 / 998 (0.10%)
    1 / 504 (0.20%)
    19 / 18369 (0.10%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 1
    0 / 1
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    13 / 18316 (0.07%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 0
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis mesenteric vessel
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Terminal ileitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    5 / 18316 (0.03%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute generalised exanthematous pustulosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blister
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic wound
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Excessive skin
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hidradenitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Panniculitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Petechiae
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intertrigo
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    56 / 18316 (0.31%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    35 / 18369 (0.19%)
         occurrences causally related to treatment / all
    0 / 59
    0 / 0
    0 / 0
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anuria
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Bladder perforation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder prolapse
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    12 / 18316 (0.07%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    17 / 18316 (0.09%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis rapidly progressive
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertonic bladder
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    26 / 18316 (0.14%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    28 / 18369 (0.15%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 0
    0 / 0
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postrenal failure
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal artery thrombosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cortical necrosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cyst haemorrhage
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cyst ruptured
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Renal haematoma
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal disorder
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal vascular thrombosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stag horn calculus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcapsular renal haematoma
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric fistula
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral obstruction
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urge incontinence
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral meatus stenosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    15 / 18369 (0.08%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Ureterolithiasis
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral cyst
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary hesitation
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperparathyroidism primary
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal mass
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basedow's disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal haemorrhage
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoparathyroidism secondary
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Primary hyperaldosteronism
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyrotoxic crisis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Articular calcification
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    13 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    24 / 18316 (0.13%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    26 / 18369 (0.14%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 0
    0 / 0
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone cyst
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exostosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma muscle
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Greater trochanteric pain syndrome
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture pain
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture nonunion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligamentum flavum hypertrophy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kyphoscoliosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    14 / 18369 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 1
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint instability
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    15 / 18316 (0.08%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc compression
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    108 / 18316 (0.59%)
    2 / 998 (0.20%)
    4 / 504 (0.79%)
    114 / 18369 (0.62%)
         occurrences causally related to treatment / all
    0 / 109
    0 / 2
    0 / 4
    0 / 120
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck mass
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seronegative arthritis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    12 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff tear arthropathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patellofemoral pain syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Osteoporotic fracture
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal retrolisthesis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal deformity
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sjogren's syndrome
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Torticollis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal sepsis
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Abdominal abscess
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess intestinal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess jaw
         subjects affected / exposed
    0 / 18316 (0.00%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendiceal abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute hepatitis C
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asymptomatic COVID-19
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asymptomatic bacteriuria
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    22 / 18316 (0.12%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 0
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical mycobacterial infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cellulitis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain abscess
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial prostatitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial food poisoning
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    43 / 18316 (0.23%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    25 / 18369 (0.14%)
         occurrences causally related to treatment / all
    0 / 45
    0 / 0
    0 / 0
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cellulitis orbital
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholera
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dacryocystitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    6 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    24 / 18316 (0.13%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    26 / 18369 (0.14%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 0
    0 / 1
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Dysentery
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    24 / 18316 (0.13%)
    1 / 998 (0.10%)
    1 / 504 (0.20%)
    24 / 18369 (0.13%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 1
    0 / 1
    0 / 26
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue haemorrhagic fever
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Echinococciasis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysematous cystitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extradural abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Focal peritonitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fournier's gangrene
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder abscess
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    16 / 18316 (0.09%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    25 / 18369 (0.14%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 0
    0 / 0
    0 / 26
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Gastric infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gingivitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Giardiasis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Haemophilus infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    H3N2 influenza
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HCoV-OC43 infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HIV infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes oesophagitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cyst infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocele male infected
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    19 / 18316 (0.10%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    13 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 0
    0 / 0
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective spondylitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal tuberculosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Latent syphilis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leptospirosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Lung abscess
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycobacterial infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Murine typhus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucormycosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metapneumovirus pneumonia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycobacterium avium complex infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis borrelia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    12 / 18316 (0.07%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    16 / 18369 (0.09%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 0
    0 / 0
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pasteurella infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    1 / 504 (0.20%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perihepatic abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasmodium vivax infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal disease
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    147 / 18316 (0.80%)
    3 / 998 (0.30%)
    2 / 504 (0.40%)
    163 / 18369 (0.89%)
         occurrences causally related to treatment / all
    0 / 163
    0 / 3
    0 / 2
    0 / 182
         deaths causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 9
    Pneumonia influenzal
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    8 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    11 / 18316 (0.06%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumonia klebsiella
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia necrotising
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Prosthetic valve endocarditis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoas abscess
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Puncture site infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    10 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    12 / 18369 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Respiratory tract infection fungal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shigella infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    22 / 18316 (0.12%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    21 / 18369 (0.11%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 0
    0 / 0
    0 / 21
         deaths causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 7
    Septic encephalopathy
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    44 / 18316 (0.24%)
    2 / 998 (0.20%)
    1 / 504 (0.20%)
    25 / 18369 (0.14%)
         occurrences causally related to treatment / all
    0 / 44
    0 / 2
    0 / 1
    0 / 26
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 3
    Scrotal infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrotal cellulitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal osteomyelitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Strongyloidiasis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stoma site cellulitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal skin infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis septic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tetanus
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superinfection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Submandibular abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tinea capitis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tinea pedis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis bacterial
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic shock syndrome streptococcal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract candidiasis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    5 / 18369 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection staphylococcal
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    76 / 18316 (0.41%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    66 / 18369 (0.36%)
         occurrences causally related to treatment / all
    0 / 81
    0 / 0
    0 / 0
    0 / 74
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Vascular device infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    13 / 18316 (0.07%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral sepsis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    25 / 18316 (0.14%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    28 / 18369 (0.15%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 0
    0 / 0
    1 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    5 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    4 / 18316 (0.02%)
    1 / 998 (0.10%)
    0 / 504 (0.00%)
    8 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Fluid retention
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyslipidaemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    4 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food intolerance
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Hyperkalaemia
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    3 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    9 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    7 / 18369 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Hypokalaemia
         subjects affected / exposed
    6 / 18316 (0.03%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    10 / 18369 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    4 / 18316 (0.02%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    7 / 18316 (0.04%)
    0 / 998 (0.00%)
    2 / 504 (0.40%)
    16 / 18369 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 2
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic alkalosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    2 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    2 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    3 / 18369 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock hypoglycaemic
         subjects affected / exposed
    1 / 18316 (0.01%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    0 / 18369 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    9 / 18316 (0.05%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    11 / 18369 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Uraemic acidosis
         subjects affected / exposed
    0 / 18316 (0.00%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1 / 18369 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A: Placebo Part B: mRNA-1345 Part B: Placebo Part A: mRNA-1345
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6916 / 18316 (37.76%)
    48 / 998 (4.81%)
    29 / 504 (5.75%)
    7080 / 18369 (38.54%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1225 / 18316 (6.69%)
    8 / 998 (0.80%)
    2 / 504 (0.40%)
    1244 / 18369 (6.77%)
         occurrences all number
    1303
    8
    2
    1351
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3302 / 18316 (18.03%)
    22 / 998 (2.20%)
    14 / 504 (2.78%)
    3404 / 18369 (18.53%)
         occurrences all number
    3722
    22
    14
    3830
    Upper respiratory tract infection
         subjects affected / exposed
    2153 / 18316 (11.75%)
    17 / 998 (1.70%)
    13 / 504 (2.58%)
    2198 / 18369 (11.97%)
         occurrences all number
    3215
    18
    15
    3300
    Nasopharyngitis
         subjects affected / exposed
    1384 / 18316 (7.56%)
    0 / 998 (0.00%)
    0 / 504 (0.00%)
    1430 / 18369 (7.78%)
         occurrences all number
    2735
    0
    0
    2893
    Rhinovirus infection
         subjects affected / exposed
    1683 / 18316 (9.19%)
    2 / 998 (0.20%)
    3 / 504 (0.60%)
    1698 / 18369 (9.24%)
         occurrences all number
    2091
    2
    3
    2158

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Sep 2022
    The changes in this amendment included the following: • Update to primary efficacy endpoints: Added RSV-LRTD case definition requiring 3 or more symptoms of LRTD to be present. This endpoint (corresponding to the second case definition) was tested in a hierarchical fashion after RSV-LRTD with 2 or more LRTD symptoms. • Increase in planned study sample size to 37000 participants to provide adequate power for the RSV-LRTD with 3 or more symptoms endpoint. • Futility analysis removed because study enrollment would have been nearly complete when the data safety monitoring board (DSMB) reviewed the futility analysis results.
    16 Nov 2022
    This amendment was implemented to harmonize the prespecified efficacy statistical success criteria with the published criteria, through an updated interim analysis success criterion of a lower bound of the alpha-adjusted CI of VE >20%, using an updated alpha-spending approach of Lan-DeMets Pocock approximation function. In addition, the amendment clarified that visits due to surveillance for RSV (per-protocol illness visits) that would normally have not resulted in consultation of a healthcare professional (HCP) were not to be reported as MAAEs.

    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
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    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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