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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.pre F-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older

    Summary
    EudraCT number
    		 2020-005458-97
    Trial protocol
    		 FI  
    Global end of trial date
    21 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2024
    First version publication date
    06 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VAC18193RSV3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04908683
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines & Prevention B.V.
    Sponsor organisation address
    Archimedesweg 4-6, Leiden, Netherlands, 2333 CN
    Public contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.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
    21 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to demonstrate the efficacy of the active adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilised F protein (Ad26.RSV.preF) based study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR confirmed RSV-mediated lower respiratory tract disease (LRTD) when compared to placebo in adults aged 60 years and above.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jul 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
    Australia: 37
    Country: Number of subjects enrolled
    Brazil: 178
    Country: Number of subjects enrolled
    Canada: 824
    Country: Number of subjects enrolled
    Chile: 251
    Country: Number of subjects enrolled
    China: 1993
    Country: Number of subjects enrolled
    Estonia: 233
    Country: Number of subjects enrolled
    Finland: 56
    Country: Number of subjects enrolled
    United Kingdom: 1404
    Country: Number of subjects enrolled
    New Zealand: 673
    Country: Number of subjects enrolled
    Poland: 1573
    Country: Number of subjects enrolled
    Thailand: 311
    Country: Number of subjects enrolled
    Taiwan: 183
    Country: Number of subjects enrolled
    United States: 15448
    Country: Number of subjects enrolled
    South Africa: 1912
    Worldwide total number of subjects
    25076
    EEA total number of subjects
    1862
    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)
    2212
    From 65 to 84 years
    22587
    85 years and over
    277

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 25236 subjects were randomised, out of which 25076 were vaccinated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Ad26.RSV.preF and RSV preF Protein
    Arm description
    		 Subjects received a single intramuscular (IM) injection containing a mixture of Ad26.RSV.preF at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.RSV.preF and RSV preF protein
    Investigational medicinal product code
    Other name
    JNJ-64400141
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.

    Arm title
    		 Group 2: Placebo
    Arm description
    		 Subjects received a single IM injection of matching placebo on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received an IM injection of matching placebo on Day 1.

    Number of subjects in period 1
    		Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Started
    16709
    8367
    Completed
    124
    59
    Not completed
    16585
    8308
         Adverse event, serious fatal
    101
    61
         Physician decision
    44
    35
         Subject met eligibility criteria but not needed
    3
    1
         Initiated prohibited medication
    3
    -
         Technical problems
    12
    9
         - Unspecified
    92
    50
         Withdrawal by legally authorised representative
    1
    -
         Failure to meet continuation criteria
    34
    22
         Withdrawal by subject
    1188
    570
         Randomised by mistake
    1
    -
         Adverse event, non-fatal
    21
    11
         Sponsor Decision
    14398
    7205
         Site Closure by Sponsor
    6
    3
         Lost to follow-up
    679
    341
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Ad26.RSV.preF and RSV preF Protein
    Reporting group description
    		 Subjects received a single intramuscular (IM) injection containing a mixture of Ad26.RSV.preF at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.

    Reporting group title
    Group 2: Placebo
    Reporting group description
    		 Subjects received a single IM injection of matching placebo on Day 1.

    Reporting group values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo Total
    Number of subjects
    		 16709 8367 25076
    Title for AgeCategorical
    Baseline characteristics data were analysed on Full analysis set (FAS) which included all subjects with a documented vaccine administration, regardless of the occurrence of protocol deviations.
    Units: subjects
        Adults (60-64 years)
    		 1472 740 2212
        From 65 to 84 years
    		 15053 7534 22587
        85 years and over
    		 184 93 277
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.2 ( 5.24 ) 70.2 ( 5.23 ) -
    Title for Gender
    Units: subjects
        Female
    		 9063 4452 13515
        Male
    		 7645 3913 11558
        Others
    		 1 2 3
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 58 17 75
        Asian
    		 1757 897 2654
        Native Hawaiian or Other Pacific Islander
    		 98 49 147
        Black or African American
    		 1820 935 2755
        White
    		 12649 6297 18946
        More than one race
    		 189 101 290
        Unknown or Not Reported
    		 138 71 209
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1555 741 2296
        Not Hispanic or Latino
    		 14903 7496 22399
        Unknown or Not Reported
    		 251 130 381

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Ad26.RSV.preF and RSV preF Protein
    Reporting group description
    		 Subjects received a single intramuscular (IM) injection containing a mixture of Ad26.RSV.preF at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.

    Reporting group title
    Group 2: Placebo
    Reporting group description
    		 Subjects received a single IM injection of matching placebo on Day 1.

    Primary: Number of Subjects With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)

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    End point title
    		 Number of Subjects With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD) [1]
    End point description
    A subject was considered to have RT-PCR-confirmed RSV-mediated LRTD if following criteria were met: new onset/worsening from baseline of 3/more symptoms as captured on respiratory infection intensity and impact questionnaire (RiiQ, version 2) at same time point: cough, short of breath, coughing up phlegm (sputum) & wheezing and confirmation of RSV by RT-PCR in one/more of nasal swabs/sputum sample. RiiQ symptom scale: 13-items questionnaire, each symptom was rated on 4-point scale: 0 to 3 (0=None,1=Mild,2=Moderate,3=Severe). Higher scores=greater severity. Total LRTD symptom score: mean of 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] & wheezing). Per-protocol efficacy population: all randomised and vaccinated subjects, excluding those with major protocol deviations expecting to impact efficacy outcomes. Subjects with an RSV onset within 14 days after vaccination and who discontinued within 14 days after vaccination were excluded from PPE population.
    End point type
    Primary
    End point timeframe
    From Baseline (Day 1) up to 12 months
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    16263
    8152
    Units: Subjects
    44
    63
    No statistical analyses for this end point

    Secondary: Number of Subjects With First Occurrence of any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)

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    End point title
    		 Number of Subjects With First Occurrence of any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)
    End point description
    A subject was considered to have RT-PCR-confirmed RSV-mediated ARI if the following were met: new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ at the same time point : sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one/more of the nasal swabs/ sputum sample. RiiQ symptom scale: 13-items questionnaire, each symptom was rated on 4-point scale: 0 to 3 (0=None, 1=Mild, 2=Moderate, and 3=Severe). Higher scores= greater severity. The total ARI symptom score: mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] & wheezing). PPE: all randomised and vaccinated subjects, excluding those with major protocol deviations expecting to impact efficacy outcomes. Subjects with an RSV onset within 14 days after vaccination and who discontinued within 14 days after vaccination were excluded from the PPE population.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) up to 12 months
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    16263
    8152
    Units: Subjects
    77
    101
    No statistical analyses for this end point

    Secondary: Number of Subjects With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year

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    End point title
    		 Number of Subjects With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year
    End point description
    A subject was considered to have RT-PCR-confirmed RSV-mediated LRTD if following criteria met: new onset/worsening from baseline of 3/more symptoms as captured on respiratory infection intensity and impact questionnaire (RiiQ) at same time point:cough, short of breath, coughing up phlegm (sputum) & wheezing and confirmation RSV by RT-PCR in one/more of nasal swabs/sputum sample. RiiQ symptom scale: 13-items questionnaire, each symptom was rated on 4-point scale:0 to 3 (0=None,1=Mild,2=Moderate,3=Severe). Higher scores=greater severity. Total LRTD symptom score: mean of 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] & wheezing). PPE:all randomised and vaccinated subjects, except those with major protocol deviations expecting to impact efficacy outcomes.Subjects with RSV onset within 14 days after vaccination and who discontinued within 14 days after vaccination excluded from PPE population.'N' signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Month 12 up to Month 24
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    10031
    5011
    Units: Subjects
    16
    29
    No statistical analyses for this end point

    Secondary: Number of Subjects With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year

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    End point title
    		 Number of Subjects With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year
    End point description
    A subject was considered to have RT-PCR-confirmed RSV-mediated ARI if following criteria met: new symptoms/worsening from baseline of at least one of symptoms as captured on respiratory infection intensity and impact questionnaire (RiiQ) at same time point: sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one/more of nasal swabs/sputum sample. RiiQ symptom scale:13-items questionnaire, each symptom was rated on 4-point scale:0 to 3 (0=None,1=Mild,2=Moderate,3=Severe). Higher scores= greater severity. Total ARI symptom score: mean of 4 lower respiratory scores (cough,short of breath, coughing up phlegm [sputum] & wheezing). PPE= all randomised and vaccinated subjects, excluding those with MPDs expecting to impact efficacy outcomes. Subjects with RSV onset within 14 days after vaccination and who discontinued within 14 days after vaccination were excluded.'N'=subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Month 12 up to Month 24
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    10031
    5011
    Units: Subjects
    39
    44
    No statistical analyses for this end point

    Secondary: Number of Subjects with First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study

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    End point title
    		 Number of Subjects with First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study
    End point description
    A subject was considered to have clinically relevant disease with specific parameters associated with an RT-PCR-confirmed RSV-mediated ARI if the following criteria met: new symptoms/worsening from baseline of at least one of the symptoms as captured on RiiQ: sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs/sputum sample; any of the following associated with ARI: hspitalisation, emergency department visit, per clinical judgement of complications, decreased oxygen saturation, tachypnea, need of supplemental oxygen, hypotension, pulmonary function test and arterial blood gas result. PPE: all randomised and vaccinated subjects, excluding those with MPDs expecting to impact efficacy outcomes. Subjects with an RSV onset within 14 days after vaccination and who discontinued within 14 days after vaccination were excluded from the PPE population.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to 24 months
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    16263
    8152
    Units: Subjects
    4
    11
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs)
    End point description
    Number of subjects with SAEs were reported. An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Full Analysis Set (FAS): will include all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'n' (number analysed) represents number of subjects who were evaluable for specified timepoints.
    End point type
    Secondary
    End point timeframe
    28 days post vaccination on Day 1 (Day 29); first year follow-up (from Day 29 up to 6 months, that is, up to Day 154
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    16709
    8367
    Units: Subjects
        28 days post vaccination on Day1 (n=16709,8367)
    119
    53
        First year follow-up (n=16532, 8275)
    446
    239
    No statistical analyses for this end point

    Secondary: Number of Subjects With Potential Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Subjects With Potential Adverse Events of Special Interest (AESIs)
    End point description
    Number of subjects with Potential AESIs were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs were embolic and thrombotic events, hematopoietic thrombocytopenia, and cerebral hemorrhage. FAS included all subjects with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'n' (number analyzed) represents number of subjects who were evaluable for specified timepoints.
    End point type
    Secondary
    End point timeframe
    28 days post vaccination on Day 1 (Day 29); first year follow-up (from Day 29 up to 6 months, that is, up to Day 154)
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    16709
    8367
    Units: Subjects
        28 days post vaccination on Day1 (n=16709,8367)
    25
    4
        First year follow-up (n=16532, 8275)
    71
    35
    No statistical analyses for this end point

    Secondary: Number of Subjects With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination

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    End point title
    		 Number of Subjects With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination
    End point description
    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational/ non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were precisely defined events that subjects were specifically asked about and which were noted by subjects in the diary. Solicited local AEs: erythema, swelling, and pain/tenderness at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration. Safety subset included all subjects that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination and unsolicited AEs for 28 days after vaccination). 'N' (Overall number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 post vaccination on Day 1 (up to Day 8)
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    2305
    1155
    Units: Subjects
    1076
    169
    No statistical analyses for this end point

    Secondary: Number of Subjects With Solicited Systemic AEs up to 7 Days After Vaccination

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    End point title
    		 Number of Subjects With Solicited Systemic AEs up to 7 Days After Vaccination
    End point description
    Number of subjects with solicited systemic AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study subject administered a medicinal(investigational/ non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fatigue, headache, myalgia, nausea, pyrexia, for which subjects were specifically questioned and noted in their diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). The safety subset included all subjects that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination). Here, 'N' (Overall number of subjects analysed) signifies participants who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Day 7 post vaccination on Day 1 (up to Day 8)
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    2305
    1155
    Units: Subjects
    1018
    236
    No statistical analyses for this end point

    Secondary: Number of Subjects With Unsolicited AEs up to 28 Days After Vaccination

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    End point title
    		 Number of Subjects With Unsolicited AEs up to 28 Days After Vaccination
    End point description
    Number of subjects with unsolicited AEs 28 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Unsolicited adverse events included all adverse events for which the subject was not specifically questioned in the subject diary. The safety subset included all subjects that consented to the collection of AEs (unsolicited AEs for 28 days after vaccination).
    End point type
    Secondary
    End point timeframe
    Up to 28 days post vaccination on Day 1 (up to Day 29)
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    2330
    1165
    Units: Subjects
    554
    206
    No statistical analyses for this end point

    Secondary: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination

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    End point title
    		 Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination
    End point description
    RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Per-protocol Immunogenicity (PPI) population included all randomised and vaccinated subjects who were part of the immuno subset (consisted of at least 360 participants, of whom ~50% were at increased risk for severe RSV disease and ~50% were 75 years or older) and for whom immunogenicity data were available. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At 14 days post vaccination on Day 1 (Day 15)
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    219
    108
    Units: Titers
    geometric mean (confidence interval 95%)
        Baseline
    7194 (6394 to 8093)
    537 (455 to 634)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Prefusion F-protein (pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days after Vaccination

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    End point title
    		 Geometric Mean Titers (GMTs) of Prefusion F-protein (pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days after Vaccination
    End point description
    GMTs of preF antibodies IgG at 14 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported. PPI population included all randomised and vaccinated subjects who were part of the immuno subset and for whom immunogenicity data were available. Here, 'N' (Overall number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    14 days post vaccination on Day 1 (Day 15)
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    219
    108
    Units: Titers
        geometric mean (confidence interval 95%)
    4932 (4477 to 5433)
    410 (348 to 484)
    No statistical analyses for this end point

    Secondary: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)

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    End point title
    		 T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
    End point description
    T-cell IFN gamma responses to RSV F protein specific peptides at 14 days after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs). PPI population included all randomized and vaccinated subjects who were part of the immuno subset and for whom immunogenicity data were available. "99999" indicated that median and lower limit of full range could not be estimated as it was below the lower limit of quantification (LLOQ). Median and lower limit of full range could not be estimated as it was below the lower limit of quantification (LLOQ: 68 SFC/10^6 PBMCs). Here, 'N' (Overall number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    14 days post vaccination on Day 1 (Day 15)
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    185
    92
    Units: SFC/10^6 PBMCs
        median (full range (min-max))
    533 (306 to 873)
    -99999 (-99999 to 78)
    No statistical analyses for this end point

    Secondary: Area Under the Curve (AUC) of the Change from Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score

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    End point title
    		 Area Under the Curve (AUC) of the Change from Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
    End point description
    RiiQ symptom scale:13-items questionnaire, each symptom was rated on 4-point scale:0 to 3 (0=None, 1=Mild, 2=Moderate, and 3=Severe). Higher scores indicated greater severity. Respiratory symptoms included 2 upper respiratory tract infection (RTI) symptoms (nasal congestion and sore throat), 4 lower RTI symptoms (cough, wheezing, short of breath, and coughing up phlegm/sputum) and 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, & loss of appetite). The AUC for the change from baseline for RiiQ total symptom score and RiiQ lower respiratory symptom score during the ARI was be calculated. PPE: all randomized and vaccinated subjects, excluding those with MPDs expecting to impact the efficacy outcomes. Subjects with an RSV onset within 14 days after vaccination and who discontinued within 14 days after vaccination were excluded from the PPE population. Here, 'N' signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to 24 months
    End point values
    		 Group 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
    Number of subjects analysed
    115
    143
    Units: Symptoms*Hours
        median (inter-quartile range (Q1-Q3))
    82 (21 to 141)
    107 (48 to 218)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 up to 24 months post-vaccination on Day 1 (Day 731).
    Adverse event reporting additional description
    All-cause mortality and Serious AEs were analyzed on Full analysis set population. Other (not including serious) AEs as solicited and unsolicited AEs were collected and analyzed on a subset of FAS that is called safety subset. The safety subset included all participants that consented to the collection of AEs (solicited and unsolicited AEs).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
    Reporting group description
    		 Subjects received a single intramuscular (IM) injection containing a mixture of Ad26.RSV.preF at a dose of 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.

    Reporting group title
    Group 2: Placebo (Placebo)
    Reporting group description
    		 Subjects received a single IM injection of matching placebo on Day 1.

    Serious adverse events
    		 Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) Group 2: Placebo (Placebo)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    842 / 16709 (5.04%)
    457 / 8367 (5.46%)
         number of deaths (all causes)
    105
    61
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign Renal Neoplasm
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Myeloid Leukaemia
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute Promyelocytic Leukaemia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma of Colon
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-Cell Lymphoma
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    11 / 16709 (0.07%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain Stem Glioma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cancer Pain
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral Haemangioma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix Carcinoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Lymphocytic Leukaemia
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    3 / 16709 (0.02%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer Stage I
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal Cancer
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Desmoplastic Melanoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Squamous Cell Carcinoma Stage Iv
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bowen's Disease
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Neoplasm
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain Neoplasm Malignant
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer Stage Ii
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Cancer Stage I
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Cancer Stage Ii
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic Cancer Stage Iv
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatocellular Carcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's Disease
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Metastasis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intraductal Proliferative Breast Lesion
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive Breast Carcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive Lobular Breast Carcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Benign Neoplasm
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Adenocarcinoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Carcinoma Cell Type Unspecified Stage I
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Carcinoma Cell Type Unspecified Stage Iii
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocytic Leukaemia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma Stage Iii
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma in Situ
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Gastric Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic Malignant Melanoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Renal Cell Carcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucinous Breast Carcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic Syndrome
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm Malignant
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-Hodgkin's Lymphoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Small Cell Lung Cancer Stage Iv
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal Carcinoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestine Adenocarcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Cell Lung Cancer Metastatic
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue Neoplasm Malignant Stage Unspecified
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic Carcinoma Stage Iv
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pituitary Tumour Benign
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma Cell Myeloma
         subjects affected / exposed
    0 / 16709 (0.00%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleomorphic Adenoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia Vera
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    18 / 16709 (0.11%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer Metastatic
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Adenocarcinoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer Stage Iv
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cancer
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Cell Lung Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of Lung
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil Cancer
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Cancer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive Emergency
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    6 / 16709 (0.04%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extravasation Blood
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    15 / 16709 (0.09%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    4 / 17
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arteriosclerosis
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Occlusive Disease
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Stenosis
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Dissection
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Aneurysm
         subjects affected / exposed
    4 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Shock Haemorrhagic
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Shock
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Thrombosis
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Stenosis
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White Coat Hypertension
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    5 / 16709 (0.03%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Urgency
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous Thrombosis Limb
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Aneurysm
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Death
         subjects affected / exposed
    18 / 16709 (0.11%)
    18 / 8367 (0.22%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 18
         deaths causally related to treatment / all
    0 / 18
    0 / 18
    Accidental Death
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Asthenia
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Discomfort
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    3 / 16709 (0.02%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication Associated with Device
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Withdrawal Syndrome
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malaise
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Organ Dysfunction Syndrome
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthetic Cardiac Valve Thrombosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Death
         subjects affected / exposed
    2 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Vascular Stent Stenosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Amyloidosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic Reaction
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic Shock
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Loss of Personal Independence in Daily Activities
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    3 / 16709 (0.02%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cyst
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Prolapse
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterovaginal Prolapse
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Pulmonary Oedema
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute Respiratory Failure
         subjects affected / exposed
    18 / 16709 (0.11%)
    7 / 8367 (0.08%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 7
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Asthma
         subjects affected / exposed
    4 / 16709 (0.02%)
    5 / 8367 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Chronic
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    4 / 16709 (0.02%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    6 / 16709 (0.04%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystic Lung Disease
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    31 / 16709 (0.19%)
    14 / 8367 (0.17%)
         occurrences causally related to treatment / all
    1 / 33
    0 / 14
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Pulmonary Mass
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Thrombosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    5 / 16709 (0.03%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Sinus Disorder
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    1 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pharyngeal Mass
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    5 / 16709 (0.03%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic Pain
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    4 / 16709 (0.02%)
    5 / 8367 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax Spontaneous
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    29 / 16709 (0.17%)
    9 / 8367 (0.11%)
         occurrences causally related to treatment / all
    5 / 29
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Pulmonary Haemorrhage
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary Hypertension
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep Apnoea Syndrome
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Neurosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed Suicide
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Confusional State
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Drug Abuse
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device Loosening
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Malfunction
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Pacing Issue
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Dislocation
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Chronic
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Stone
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Tract Disorder
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis Acute
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    4 / 16709 (0.02%)
    8 / 8367 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    4 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    3 / 16709 (0.02%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Failure
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic Haemorrhage
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal Syndrome
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic Cirrhosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Body Temperature Increased
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Murmur
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Computerised Tomogram Thorax Abnormal
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram Abnormal
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart Rate Increased
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Human Metapneumovirus Test Positive
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sars-Cov-2 Test Positive
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Extradural Haematoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    1 / 16709 (0.01%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Injury
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asbestosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Injury
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Contusion
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Vertebral Fracture
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle Fracture
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Contusion
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face Injury
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Injury
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    4 / 16709 (0.02%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    6 / 16709 (0.04%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    3 / 16709 (0.02%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand Fracture
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun Shot Wound
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Foreign Body in Skin or Subcutaneous Tissue
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    8 / 16709 (0.05%)
    5 / 8367 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    1 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    5 / 16709 (0.03%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Bones Fracture
         subjects affected / exposed
    0 / 16709 (0.00%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Ileus
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Vaccination Syndrome
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Complication
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax Traumatic
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic Fracture
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprocedural Myocardial Infarction
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Fracture
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck Injury
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    1 / 16709 (0.01%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Contusion
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Complication
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to Various Agents
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Traumatic Haematoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Haemothorax
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    10 / 16709 (0.06%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Seroma
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Injury
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Laceration
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Wound
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    6 / 16709 (0.04%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural Haemorrhage
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Intracranial Haematoma
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    1 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Dehiscence
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Lung Injury
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic Cardiomyopathy
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitello-Intestinal Duct Remnant
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Left Ventricular Failure
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    17 / 16709 (0.10%)
    10 / 8367 (0.12%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac Failure Chronic
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    2 / 16709 (0.01%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Incompetence
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Stenosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    24 / 16709 (0.14%)
    13 / 8367 (0.16%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Thrombosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    8 / 16709 (0.05%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 6
    0 / 1
    Cardiac Failure
         subjects affected / exposed
    7 / 16709 (0.04%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Angina Pectoris
         subjects affected / exposed
    6 / 16709 (0.04%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    15 / 16709 (0.09%)
    6 / 8367 (0.07%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Ventricular Thrombosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Cardiogenic Shock
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiomyopathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Coronary Syndrome
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conduction Disorder
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive Cardiomyopathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cor Pulmonale
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cor Pulmonale Chronic
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    14 / 16709 (0.08%)
    11 / 8367 (0.13%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary Artery Occlusion
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Thrombosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Heart Disease
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interventricular Septum Rupture
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac Valve Disease
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Disease
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Stenosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    23 / 16709 (0.14%)
    12 / 8367 (0.14%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 13
         deaths causally related to treatment / all
    0 / 11
    0 / 4
    Myocardial Ischaemia
         subjects affected / exposed
    1 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Arrest
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Bradycardia
         subjects affected / exposed
    0 / 16709 (0.00%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Tachycardia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress Cardiomyopathy
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Arrhythmia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Extrasystoles
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Disorder
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balance Disorder
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal Ganglia Haemorrhage
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bell's Palsy
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Injury
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Carotid Artery Disease
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar Stroke
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Haemorrhage
         subjects affected / exposed
    2 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cerebral Infarction
         subjects affected / exposed
    9 / 16709 (0.05%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Mass Effect
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral Venous Sinus Thrombosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal Fluid Leakage
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    20 / 16709 (0.12%)
    8 / 8367 (0.10%)
         occurrences causally related to treatment / all
    0 / 20
    1 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Cervical Radiculopathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Radiculopathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness Postural
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic Stroke
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epilepsy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised Tonic-Clonic Seizure
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage Intracranial
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Haemorrhagic Stroke
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Encephalopathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intracranial Aneurysm
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intracranial Mass
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    7 / 16709 (0.04%)
    7 / 8367 (0.08%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar Infarction
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar Stroke
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of Consciousness
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral Radiculopathy
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    7 / 16709 (0.04%)
    7 / 8367 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia Gravis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenic Syndrome
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve Compression
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy Peripheral
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic Migraine
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's Disease
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial Seizures
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Progressive Supranuclear Palsy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 16709 (0.01%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Claudication
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid Haemorrhage
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Monoplegia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo CNS Origin
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Dementia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal Neuralgia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    15 / 16709 (0.09%)
    11 / 8367 (0.13%)
         occurrences causally related to treatment / all
    1 / 15
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Global Amnesia
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic Encephalopathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 16709 (0.03%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Megaloblastic
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated Intravascular Coagulation
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    4 / 16709 (0.02%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy Mediastinal
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 16709 (0.01%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Angle Closure Glaucoma
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular Myasthenia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pterygium
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision Blurred
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Hernia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    5 / 16709 (0.03%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fissure
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    3 / 16709 (0.02%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular Perforation
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Intestinal Haemorrhagic
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Perforation
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Polyps
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Perforation
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Gastritis
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Erosive
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Gastrointestinal Perforation
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Ulcer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus Hernia
         subjects affected / exposed
    5 / 16709 (0.03%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia Strangulated
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    6 / 16709 (0.04%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Perforation
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Irritable Bowel Syndrome
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Polyp
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric Panniculitis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Haemorrhage
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Rupture
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    2 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer Haemorrhage
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Polyp
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    8 / 16709 (0.05%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Perforation
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spigelian Hernia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue Dysplasia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    3 / 16709 (0.02%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Varices Haemorrhage
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Decubitus Ulcer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot
         subjects affected / exposed
    1 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkeratosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Prerenal Failure
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    4 / 16709 (0.02%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritic Syndrome
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End Stage Renal Disease
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic Kidney Disease
         subjects affected / exposed
    2 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Kidney Injury
         subjects affected / exposed
    7 / 16709 (0.04%)
    5 / 8367 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Colic
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Caruncle
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Mass
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Injury
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Haemorrhage
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Incontinence
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Disorder
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Myxoedema
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary Cyst
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Pain
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 16709 (0.01%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    4 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Spinal Stenosis
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inclusion Body Myositis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intervertebral Disc Degeneration
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    4 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Effusion
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    16 / 16709 (0.10%)
    13 / 8367 (0.16%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic Fracture
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia Rheumatica
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid Arthritis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    3 / 16709 (0.02%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Necrosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    0 / 16709 (0.00%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Stenosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral Foraminal Stenosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis Perforated
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Abscess
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Jaw
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorectal Cellulitis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Beta Haemolytic Streptococcal Infection
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchitis
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Viral
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    6 / 16709 (0.04%)
    5 / 8367 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis Staphylococcal
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Colitis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic Abscess
         subjects affected / exposed
    1 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus Pneumonia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Covid-19
         subjects affected / exposed
    29 / 16709 (0.17%)
    12 / 8367 (0.14%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Covid-19 Pneumonia
         subjects affected / exposed
    6 / 16709 (0.04%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungaemia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Sepsis
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiglottic Abscess
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Infectious
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal Sepsis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis Intestinal Perforated
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    5 / 16709 (0.03%)
    5 / 8367 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gangrene
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 16709 (0.03%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Salmonella
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter Gastritis
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Bite
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural Abscess
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningoencephalitis Herpetic
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Abscess
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    7 / 16709 (0.04%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Localised Infection
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Abscess
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Discitis
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 16709 (0.01%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infectious Pleural Effusion
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Legionella
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Influenzal
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    5 / 16709 (0.03%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pneumonia
         subjects affected / exposed
    46 / 16709 (0.28%)
    26 / 8367 (0.31%)
         occurrences causally related to treatment / all
    0 / 48
    0 / 26
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Pharyngitis Streptococcal
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Perirectal Abscess
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 16709 (0.01%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Streptococcal
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Abscess
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    15 / 16709 (0.09%)
    9 / 8367 (0.11%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Wound Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Labyrinthitis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 16709 (0.00%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    7 / 16709 (0.04%)
    4 / 8367 (0.05%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 16709 (0.02%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal Sepsis
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis Fungal
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    4 / 16709 (0.02%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Postoperative Abscess
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to Thrive
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased Appetite
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    5 / 16709 (0.03%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    3 / 16709 (0.02%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    4 / 16709 (0.02%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte Imbalance
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    2 / 16709 (0.01%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    3 / 16709 (0.02%)
    2 / 8367 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 16709 (0.00%)
    1 / 8367 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic Acidosis
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    1 / 16709 (0.01%)
    3 / 8367 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 16709 (0.01%)
    0 / 8367 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) Group 2: Placebo (Placebo)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1477 / 16709 (8.84%)
    408 / 8367 (4.88%)
    Investigations
    Blood Pressure Diastolic Increased
         subjects affected / exposed [1]
    58 / 2330 (2.49%)
    21 / 1165 (1.80%)
         occurrences all number
    58
    21
    Blood Pressure Systolic Increased
         subjects affected / exposed [2]
    150 / 2330 (6.44%)
    60 / 1165 (5.15%)
         occurrences all number
    150
    60
    Respiratory Rate Increased
         subjects affected / exposed [3]
    89 / 2330 (3.82%)
    49 / 1165 (4.21%)
         occurrences all number
    89
    49
    Nervous system disorders
    Headache(Solicited)
         subjects affected / exposed [4]
    597 / 2330 (25.62%)
    128 / 1165 (10.99%)
         occurrences all number
    597
    128
    General disorders and administration site conditions
    Fatigue(Solicited)
         subjects affected / exposed [5]
    789 / 2330 (33.86%)
    165 / 1165 (14.16%)
         occurrences all number
    789
    165
    Pain
         subjects affected / exposed [6]
    48 / 2330 (2.06%)
    12 / 1165 (1.03%)
         occurrences all number
    61
    18
    Pyrexia(Solicited)
         subjects affected / exposed [7]
    171 / 2330 (7.34%)
    5 / 1165 (0.43%)
         occurrences all number
    171
    5
    Vaccination Site Erythema(Solicited)
         subjects affected / exposed [8]
    63 / 2330 (2.70%)
    5 / 1165 (0.43%)
         occurrences all number
    63
    5
    Vaccination Site Pain(Solicited)
         subjects affected / exposed [9]
    1065 / 2330 (45.71%)
    168 / 1165 (14.42%)
         occurrences all number
    1065
    168
    Vaccination Site Swelling(Solicited)
         subjects affected / exposed [10]
    68 / 2330 (2.92%)
    3 / 1165 (0.26%)
         occurrences all number
    68
    3
    Gastrointestinal disorders
    Nausea(Solicited)
         subjects affected / exposed [11]
    324 / 2330 (13.91%)
    75 / 1165 (6.44%)
         occurrences all number
    324
    75
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed [12]
    68 / 2330 (2.92%)
    25 / 1165 (2.15%)
         occurrences all number
    74
    26
    Musculoskeletal and connective tissue disorders
    Myalgia(Solicited)
         subjects affected / exposed [13]
    614 / 2330 (26.35%)
    119 / 1165 (10.21%)
         occurrences all number
    614
    119
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious AEs which included solicited and unsolicited AEs were collected and analyzed in a subset of FAS that is called safety subset. The safety subset included all subjects that consented to the collection of AEs (solicited and unsolicited AEs).

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 May 2021
    The purpose of this amendment was to follow recommendations from regulatory authorities (eg, update of the primary hypothesis of vaccine efficacy against RT-PCR- confirmed RSV mediated lower respiratory tract disease (LRTD), stratification and minimization factors for the randomization, secondary endpoints testing strategy).
    19 Jul 2021
    The purpose of this amendment was to align the information and guidance for investigators on signs and symptoms and on medical management of thrombosis with thrombocytopenia syndrome (TTS) events across the VAC18193 program.
    10 Nov 2021
    The purpose of this amendment was to align the protocol following comments from CBER that all cases meeting the programmed case definition of RT-PCR confirmed RSV lower respiratory tract disease (LRTD) should be reviewed by the Clinical Event Adjudication Committee (CEC).
    08 Apr 2022
    The purpose of this amendment was to available immunogenicity data generated in ongoing clinical studies with the Ad26/protein preF RSV vaccine suggest that immune responses after a single vaccination are durable beyond one year, and that a revaccination at Month 12 is likely not necessary for efficacy. Therefore, the second dose at Month 12 has been removed from the protocol.
    11 Oct 2022
    The purpose of this amendment was to provide clarification around the timing of the end-of-study analyses and population included, to align risk language with the most recent safety data available, and to provide additional clarification around follow-up that is conducted via phone call versus onsite visit.

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

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