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    Clinical Trial Results:
    A Phase III Safety and Efficacy Study to Compare Immune Responses following Injection with Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®

    Summary
    EudraCT number
    		 2006-006743-31
    Trial protocol
    		 DE  
    Global end of trial date
    03 Oct 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DV2-HBV-10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00435812
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dynavax Technologies Corporation
    Sponsor organisation address
    2100 Powell Street, Suite 720, Emeryville, United States, California 94608
    Public contact
    Robert Janssen, Dynavax Technologies Corporation, 01 510-665-0414 x:1414, rjanssen@dynavax.com
    Scientific contact
    Robert Janssen, Dynavax Technologies Corporation, 01 510-665-0414 x:1414, rjanssen@dynavax.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Nov 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Mar 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary efficacy objective of this trial is to compare the proportion of subjects who exhibit seroprotective immune response (SPR - anti-HBsAg antibodies [anti-HBsAg] ≥ 10 mIU/ml by AUSAB® assay) when measured at Week 12 following vaccination with HEPLISAV at 0 and 1 month to the proportion of subjects who exhibit SPRs when measured at Week 28 following vaccination with Engerix-B at 0, 1 and 6 months.
    Protection of trial subjects
    This study was conducted in accordance with the protocol, good clinical practice (GCP) as defined in the International Conference on Harmonisation (ICH) guidelines, country-specific laws and regulations governing clinical studies of investigational products, and the Declaration of Helsinki (1989). Subjects could withdraw their consent to participate at any time without prejudice. Also, the investigator could withdraw a subject from further treatment if, in the investigator’s clinical judgment, it was in the best interest of the subject or if the subject was unable to comply with protocol requirements. For subjects who were discontinued from the study due to adverse events (AEs), the AE was monitored until resolution or, if the event was determined to be chronic it was monitored until it was stable. If the event remained unresolved at the conclusion of the study, a clinical assessment was made by the investigator and medical monitor to determine whether continued follow-up of the event was warranted. Subjects who were not seroprotected at Week 28 were offered an optional additional injection of Engerix-B and were provided with the anti-HBsAg test results following the additional injection. The optional additional vaccination and test results were outside of protocol procedures and were not captured in the database. In the event the Sponsor stopped the study prior to completion, subjects were to be offered Engerix-B.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Dec 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 1489
    Country: Number of subjects enrolled
    Germany: 939
    Worldwide total number of subjects
    2428
    EEA total number of subjects
    939
    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)
    13
    Adults (18-64 years)
    2415
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 11-55 yrs recruited in Canada, 18-55 yrs recruited in Germany (age adjustment in 1st Amendment). Canada recruitment period: 12-Dec-2006 to 11-July-2007. Germany recruitment period 08-Feb-2007 to 11-July-2007. 2400 subjects planned (1018 ISS-HBsAg: 1800; Engerix-B: 600); 2428 subjects enrolled and analyzed (1018 ISS-HBsAg: 1820; Engerix-B: 608)

    Pre-assignment
    Screening details
    		 Medical history, medical evaluation, vital signs, serum pregnancy, urine pregnancy prior to injection, Anti-HBsAg, Hepatitis screen, ANA and anti-ds DNA screens were all performed in the period of -28 to -3 days prior to the first study injection (at Day 0)

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject
    Blinding implementation details
    The subjects and the study personnel who evaluated them were blinded to treatment assignment. Independent pharmacists or nurses who had no other study responsibilities were not blinded so they could prepare and/or administer the study injections. In addition, an unblinded study monitor with no other study responsibilities performed drug accountability. SAEs were evaluated by the medical monitor, who remained blinded to treatment assignment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1018 ISS-HBsAg group
    Arm description
    		 Subjects in the 1018 ISS-HBsAg group received active vaccine (Heplisav-B) at Weeks 0 and 4 and saline placebo at Week 24
    Arm type
    		 Experimental

    Investigational medicinal product name
    1018 ISS-HBsAg
    Investigational medicinal product code
    Other name
    HEPLISAV, Heplisav-B
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The test product (1018 ISS-HBsAg) was 20 mcg HBsAg with 3000 mcg 1018 immunostimulatory sequence (ISS) adjuvant. Subjects received a single intramuscular injection (total injection volume 0.5 mL) into the right or left deltoid muscle at Weeks 0 and 4 (placebo at Week 24). The arm used for injection was alternated with each injection.

    Arm title
    		 Engerix-B group
    Arm description
    		 3-dose regimen of Engerix-B (Weeks 0, 4 and 24)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Engerix-B (20 mcg HBsAg combined with 500 mcg alum adjuvant/mL; GlaxoSmithKline Biologicals) administered as a single intramuscular injection (1.0 mL) into the deltoid muscle at Weeks 0, 4, and 24. The arm used for injection was alternated with each injection.

    Number of subjects in period 1
    		1018 ISS-HBsAg group Engerix-B group
    Started
    1820
    608
    Completed
    1757
    590
    Not completed
    63
    18
         Subject Non-Compliance
    3
    2
         Consent withdrawn by subject
    18
    2
         Adverse event, non-fatal
    2
    2
         Other
    8
    2
         Lost to follow-up
    30
    10
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1018 ISS-HBsAg group
    Reporting group description
    		 Subjects in the 1018 ISS-HBsAg group received active vaccine (Heplisav-B) at Weeks 0 and 4 and saline placebo at Week 24

    Reporting group title
    Engerix-B group
    Reporting group description
    		 3-dose regimen of Engerix-B (Weeks 0, 4 and 24)

    Reporting group values
    		 1018 ISS-HBsAg group Engerix-B group Total
    Number of subjects
    		 1820 608 2428
    Age categorical
    The effect of age on immunogenicity was evaluated in 4 age strata: Subjects 18 to 55 years of age Subjects 18-39 years of age Subjects 40-55 years of age Subjects 11 to 17 years of age Safety analysis populations: Subjects 11-39 years of age, and subjects 40-55 years of age
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        11-17 years
    		 11 2 13
        18-39 years
    		 818 275 1093
        40-55 years
    		 991 331 1322
        11-39
    		 0 0 0
    Age continuous
    Age mean (SD) by treatment group
    Units: years
        arithmetic mean (standard deviation)
    		 39.7 ( 9.56 ) 39.8 ( 9.11 ) -
    Gender categorical
    Male or female
    Units: Subjects
        Female
    		 959 346 1305
        Male
    		 861 262 1123
    Subject analysis sets

    Subject analysis set title
    1018 ISS-HBsAg PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The primary immunogenicity analysis was based on the PP population. The PP analysis population comprised all subjects who met eligibility criteria, did not violate the protocol in a substantial manner, received all protocol-specified study injections, had their primary serology and all injections within the specified day ranges as defined in Section 8.5 of the SAP, and had serology at their primary endpoint (Week 12 for 1018 ISS-HBsAg group).

    Subject analysis set title
    Engerix-B PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The primary immunogenicity analysis was based on the PP population. The PP analysis population comprised all subjects who met eligibility criteria, did not violate the protocol in a substantial manner, received all protocol-specified study injections, had their primary serology and all injections within the specified day ranges as defined in Section 8.5 of the SAP, and had serology at their primary endpoint (Week 28 for Engerix-B group).

    Subject analysis set title
    1018 ISS-HBsAg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Enrolled subjects who received at least 1 study injection and had any post-baseline safety data.

    Subject analysis set title
    Engerix-B Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Enrolled subjects who received at least 1 study injection and had any post-baseline safety data

    Subject analysis sets values
    		 1018 ISS-HBsAg PP Engerix-B PP 1018 ISS-HBsAg Safety Engerix-B Safety
    Number of subjects
    1520
    523
    1820
    608
    Age categorical
    The effect of age on immunogenicity was evaluated in 4 age strata: Subjects 18 to 55 years of age Subjects 18-39 years of age Subjects 40-55 years of age Subjects 11 to 17 years of age Safety analysis populations: Subjects 11-39 years of age, and subjects 40-55 years of age
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
        11-17 years
    10
    2
    0
    0
        18-39 years
    654
    222
    0
    0
        40-55 years
    856
    299
    991
    331
        11-39
    0
    0
    829
    277
    Age continuous
    Age mean (SD) by treatment group
    Units: years
        arithmetic mean (standard deviation)
    40.1 ( 9.46 )
    40.4 ( 8.94 )
    39.9 ( 9.36 )
    39.8 ( 9.01 )
    Gender categorical
    Male or female
    Units: Subjects
        Female
    815
    304
    959
    346
        Male
    705
    219
    861
    262

    End points

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    End points reporting groups
    Reporting group title
    1018 ISS-HBsAg group
    Reporting group description
    		 Subjects in the 1018 ISS-HBsAg group received active vaccine (Heplisav-B) at Weeks 0 and 4 and saline placebo at Week 24

    Reporting group title
    Engerix-B group
    Reporting group description
    		 3-dose regimen of Engerix-B (Weeks 0, 4 and 24)

    Subject analysis set title
    1018 ISS-HBsAg PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The primary immunogenicity analysis was based on the PP population. The PP analysis population comprised all subjects who met eligibility criteria, did not violate the protocol in a substantial manner, received all protocol-specified study injections, had their primary serology and all injections within the specified day ranges as defined in Section 8.5 of the SAP, and had serology at their primary endpoint (Week 12 for 1018 ISS-HBsAg group).

    Subject analysis set title
    Engerix-B PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The primary immunogenicity analysis was based on the PP population. The PP analysis population comprised all subjects who met eligibility criteria, did not violate the protocol in a substantial manner, received all protocol-specified study injections, had their primary serology and all injections within the specified day ranges as defined in Section 8.5 of the SAP, and had serology at their primary endpoint (Week 28 for Engerix-B group).

    Subject analysis set title
    1018 ISS-HBsAg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Enrolled subjects who received at least 1 study injection and had any post-baseline safety data.

    Subject analysis set title
    Engerix-B Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Enrolled subjects who received at least 1 study injection and had any post-baseline safety data

    Primary: Primary Immunogenicity Analysis: SPR after the final active injection

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    End point title
    		 Primary Immunogenicity Analysis: SPR after the final active injection
    End point description
    SPR at 12 weeks post last active injection
    End point type
    Primary
    End point timeframe
    Week 12 for 1018 ISS-HBsAg group, and Week 28 for Engerix-B group.
    End point values
    		 1018 ISS-HBsAg PP Engerix-B PP
    Number of subjects analysed
    1520
    523
    Units: percent
        number (not applicable)
    95.02
    81.36
    Statistical analysis title
    		 Primary immunogenicity analysis
    Statistical analysis description
    The primary immunogenicity analysis determined the difference in the SPR between Engerix-B at Week 28 and 1018 ISS-HBsAg at Week 12 with a 2 sided 95% CI on the difference (Engerix-B minus 1018 ISS-HBsAg) in SPR. If the upper limit of this CI is below the pre-specified non-inferiority criterion (+10%), 1018 ISS-HBsAg was non-inferior to Engerix-B in SPR.
    Comparison groups
    1018 ISS-HBsAg PP v Engerix-B PP
    Number of subjects included in analysis
    2043
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Secondary Immunogenicity Analysis: SPR measured 4 weeks after the first injection (onset of response)

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    End point title
    		 Secondary Immunogenicity Analysis: SPR measured 4 weeks after the first injection (onset of response)
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks after the first injection for both treatment groups
    End point values
    		 1018 ISS-HBsAg PP Engerix-B PP
    Number of subjects analysed
    1510
    521
    Units: percent
        number (not applicable)
    23.54
    4.06
    No statistical analyses for this end point

    Other pre-specified: Safety: Solicited post-injection reactions

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    End point title
    		 Safety: Solicited post-injection reactions
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Days 0-6 following each injection (Wks 0, 4 and 24)
    End point values
    		 1018 ISS-HBsAg Safety Engerix-B Safety
    Number of subjects analysed
    1820
    608
    Units: percent
        number (not applicable)
    52.0
    48.4
    No statistical analyses for this end point

    Other pre-specified: Safety: Change in ANA levels from baseline

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    End point title
    		 Safety: Change in ANA levels from baseline
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 28
    End point values
    		 1018 ISS-HBsAg Safety Engerix-B Safety
    Number of subjects analysed
    1820
    608
    Units: percent
    number (not applicable)
        1 dilution increase
    1.7
    1.3
        2 dilution increase
    0.5
    1.0
        3 dilution increase
    0.1
    0
        4 dilution increase
    0
    0
        >4 dilution increase
    0
    0
        At least 2 dilution increase
    0.6
    1.0
    No statistical analyses for this end point

    Other pre-specified: Safety: Change in Anti-ds DNA levels from baseline

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    End point title
    		 Safety: Change in Anti-ds DNA levels from baseline
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 28
    End point values
    		 1018 ISS-HBsAg Safety Engerix-B Safety
    Number of subjects analysed
    1820
    608
    Units: percent
    number (not applicable)
        Negative to negative
    94.8
    94.6
        Negative to positive
    0.5
    0.5
        Positive to negative
    0.3
    0.5
        Positive to positive
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any AE that began on or after the day of the first study injection, or any AE that began before the day of the first study injection and worsened on or after the day of the first study injection, and are referred to simply as AEs
    Adverse event reporting additional description
    All AEs described in this section were treatment emergent, defined according to the timeframe above. Note that AEs are referred to as unsolicited adverse experiences in the CSR.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    1018 ISS-HBsAg
    Reporting group description
    		 Subjects receiving the experimental vaccine

    Reporting group title
    Engerix-B
    Reporting group description
    		 Subjects received active comparator vaccine

    Serious adverse events
    		 1018 ISS-HBsAg Engerix-B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 1820 (1.54%)
    13 / 608 (2.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (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
    Meningioma surgery
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anti-neutrophil cytoplasmic antibody positive vasculitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    menorrhagia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         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
    Pulmonary embolism
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wegener's Granulomatosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium tremens
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Jaw fracture
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dislocation of joint prosthesis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus lesion
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         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 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (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
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (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
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adnexitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 1018 ISS-HBsAg Engerix-B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1098 / 1820 (60.33%)
    376 / 608 (61.84%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    10 / 1820 (0.55%)
    3 / 608 (0.49%)
         occurrences all number
    10
    3
    Breast cancer
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Benign breast neoplasm
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Benign neoplasm of adrenal gland
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Nasal neoplasm
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Melanocytic naevus
         subjects affected / exposed
    2 / 1820 (0.11%)
    3 / 608 (0.49%)
         occurrences all number
    2
    3
    Basal cell carcinoma
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Haemangioma of skin
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    38 / 1820 (2.09%)
    17 / 608 (2.80%)
         occurrences all number
    38
    17
    Circulatory collapse
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Phlebitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Hypotension
         subjects affected / exposed
    1 / 1820 (0.05%)
    2 / 608 (0.33%)
         occurrences all number
    1
    2
    Thrombosis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Venous insufficiency
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Haematoma
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Varicose vein
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Flushing
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Raynaud's phenomenon
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Meningioma surgery
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Wart excision
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Inguinal hernia repair
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Wisdom teeth removal
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    21 / 1820 (1.15%)
    11 / 608 (1.81%)
         occurrences all number
    21
    11
    Fatigue
         subjects affected / exposed
    24 / 1820 (1.32%)
    4 / 608 (0.66%)
         occurrences all number
    24
    4
    Influenza like illness
         subjects affected / exposed
    11 / 1820 (0.60%)
    3 / 608 (0.49%)
         occurrences all number
    11
    3
    Oedema peripheral
         subjects affected / exposed
    9 / 1820 (0.49%)
    1 / 608 (0.16%)
         occurrences all number
    9
    1
    Chills
         subjects affected / exposed
    3 / 1820 (0.16%)
    2 / 608 (0.33%)
         occurrences all number
    3
    2
    Malaise
         subjects affected / exposed
    5 / 1820 (0.27%)
    6 / 608 (0.99%)
         occurrences all number
    5
    6
    Pain
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Chest discomfort
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Polyp
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Asthenia
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Axillary pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    4 / 1820 (0.22%)
    1 / 608 (0.16%)
         occurrences all number
    4
    1
    Cyst
         subjects affected / exposed
    2 / 1820 (0.11%)
    2 / 608 (0.33%)
         occurrences all number
    2
    2
    Feeling cold
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Hangover
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    local swelling
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Thirst
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Feeling abnormal
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    lower extremity mass
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Vessel puncture site haematoma
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Vessel puncture site reaction
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Injection site bruising
         subjects affected / exposed
    11 / 1820 (0.60%)
    2 / 608 (0.33%)
         occurrences all number
    11
    2
    Injection site discomfort
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Injection site pruritus
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Facial pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Injection site pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Injection site warmth
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Injection site reaction
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Peripheral coldness
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Anti-neutrophil cytoplasmic antibody positive vasculitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Contrast media allergy
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    6 / 1820 (0.33%)
    3 / 608 (0.49%)
         occurrences all number
    6
    3
    Allergy to arthropod bite
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Hypersensitivity
         subjects affected / exposed
    3 / 1820 (0.16%)
    2 / 608 (0.33%)
         occurrences all number
    3
    2
    Food allergy
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    house dust allergy
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Allergy to plants
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    21 / 1820 (1.15%)
    8 / 608 (1.32%)
         occurrences all number
    21
    8
    Menstrual disorder
         subjects affected / exposed
    5 / 1820 (0.27%)
    2 / 608 (0.33%)
         occurrences all number
    5
    2
    Amenorrhoea
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Breast cyst
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Breast pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Breast swelling
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Dyspareunia
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Menopausal disorder
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Menorrhagia
         subjects affected / exposed
    6 / 1820 (0.33%)
    2 / 608 (0.33%)
         occurrences all number
    6
    2
    Ovarian cyst
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Pelvic pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Prostatitis
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Metrorrhagia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 1820 (0.05%)
    2 / 608 (0.33%)
         occurrences all number
    1
    2
    Vulva cyst
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Erectile dysfunction
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Breast discomfort
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Hot flush
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Menopausal symptoms
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Premenstrual syndrome
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Sexual dysfunction
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Vaginal discharge
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal discomfort
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Balanitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    2 / 608 (0.33%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal pain
         subjects affected / exposed
    80 / 1820 (4.40%)
    25 / 608 (4.11%)
         occurrences all number
    80
    25
    Cough
         subjects affected / exposed
    57 / 1820 (3.13%)
    17 / 608 (2.80%)
         occurrences all number
    57
    17
    Nasal congestion
         subjects affected / exposed
    31 / 1820 (1.70%)
    4 / 608 (0.66%)
         occurrences all number
    31
    4
    Sinus headache
         subjects affected / exposed
    14 / 1820 (0.77%)
    3 / 608 (0.49%)
         occurrences all number
    14
    3
    Rhinorrhoea
         subjects affected / exposed
    8 / 1820 (0.44%)
    0 / 608 (0.00%)
         occurrences all number
    8
    0
    Asthma
         subjects affected / exposed
    9 / 1820 (0.49%)
    2 / 608 (0.33%)
         occurrences all number
    9
    2
    Rhinitis allergic
         subjects affected / exposed
    5 / 1820 (0.27%)
    0 / 608 (0.00%)
         occurrences all number
    5
    0
    Respiratory tract congestion
         subjects affected / exposed
    5 / 1820 (0.27%)
    0 / 608 (0.00%)
         occurrences all number
    5
    0
    Dyspnoea
         subjects affected / exposed
    4 / 1820 (0.22%)
    2 / 608 (0.33%)
         occurrences all number
    4
    2
    Epistaxis
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Pharyngitis
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Dry throat
         subjects affected / exposed
    1 / 1820 (0.05%)
    2 / 608 (0.33%)
         occurrences all number
    1
    2
    Hypoxia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Nasal dryness
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Nasal polyps
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Pneumothorax
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Postnasal drip
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Sneezing
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Vocal cord disorder
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Nasal discomfort
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Pleuritic pain
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    9 / 1820 (0.49%)
    4 / 608 (0.66%)
         occurrences all number
    9
    4
    Pulmonary embolism
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Bronchitis chronic
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Dysphonia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Pleurisy
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Wegener's Granulomatosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Pleural effusion
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    21 / 1820 (1.15%)
    10 / 608 (1.64%)
         occurrences all number
    21
    10
    Stress
         subjects affected / exposed
    4 / 1820 (0.22%)
    1 / 608 (0.16%)
         occurrences all number
    4
    1
    Mood swings
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Nightmare
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Restlessness
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Delirium tremens
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Nervousness
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Panic disorder
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Anxiety disorder
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Generalised anxiety disorder
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Investigations
    Antinuclear antibody increased
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Bleeding time prolonged
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Hepatitis C positive
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    14 / 1820 (0.77%)
    7 / 608 (1.15%)
         occurrences all number
    14
    7
    Contusion
         subjects affected / exposed
    10 / 1820 (0.55%)
    3 / 608 (0.49%)
         occurrences all number
    10
    3
    Muscle strain
         subjects affected / exposed
    13 / 1820 (0.71%)
    5 / 608 (0.82%)
         occurrences all number
    13
    5
    Post procedural complication
         subjects affected / exposed
    14 / 1820 (0.77%)
    7 / 608 (1.15%)
         occurrences all number
    14
    7
    Skin laceration
         subjects affected / exposed
    8 / 1820 (0.44%)
    6 / 608 (0.99%)
         occurrences all number
    8
    6
    Soft tissue injury
         subjects affected / exposed
    5 / 1820 (0.27%)
    2 / 608 (0.33%)
         occurrences all number
    5
    2
    Epicondylitis
         subjects affected / exposed
    6 / 1820 (0.33%)
    6 / 608 (0.99%)
         occurrences all number
    6
    6
    Foot fracture
         subjects affected / exposed
    2 / 1820 (0.11%)
    2 / 608 (0.33%)
         occurrences all number
    2
    2
    meniscus lesion
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Thermal burn
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Wound
         subjects affected / exposed
    5 / 1820 (0.27%)
    0 / 608 (0.00%)
         occurrences all number
    5
    0
    Arthropod bite
         subjects affected / exposed
    5 / 1820 (0.27%)
    3 / 608 (0.49%)
         occurrences all number
    5
    3
    Arthropod sting
         subjects affected / exposed
    1 / 1820 (0.05%)
    3 / 608 (0.49%)
         occurrences all number
    1
    3
    Back injury
         subjects affected / exposed
    5 / 1820 (0.27%)
    3 / 608 (0.49%)
         occurrences all number
    5
    3
    Clavicle fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Dislocation of joint prosthesis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Incision site pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Limb injury
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Multiple injuries
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Muscle rupture
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Patella fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Rib fracture
         subjects affected / exposed
    5 / 1820 (0.27%)
    0 / 608 (0.00%)
         occurrences all number
    5
    0
    Road traffic accident
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Sternal fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Tendon rupture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Ulna fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Brachial plexus injury
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Burns first degree
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Femur fracture
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Heat stroke
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Neck injury
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Sunburn
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Tibia fracture
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Upper limb fracture
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Whiplash injury
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Ligament rupture
         subjects affected / exposed
    4 / 1820 (0.22%)
    0 / 608 (0.00%)
         occurrences all number
    4
    0
    Eye injury
         subjects affected / exposed
    2 / 1820 (0.11%)
    2 / 608 (0.33%)
         occurrences all number
    2
    2
    Jaw fracture
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Animal scratch
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Ankle fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Facial bones fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Fractured coccyx
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Head injury
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Heart injury
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Overdose
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Pelvic fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Periorbital haematoma
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Post-traumatic pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Radius fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Skeletal injury
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Wound complication
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Concussion
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Gilbert's syndrome
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    8 / 1820 (0.44%)
    4 / 608 (0.66%)
         occurrences all number
    8
    4
    Angina pectoris
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Cardiac disorder
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    206 / 1820 (11.32%)
    62 / 608 (10.20%)
         occurrences all number
    206
    62
    Dizziness
         subjects affected / exposed
    20 / 1820 (1.10%)
    7 / 608 (1.15%)
         occurrences all number
    20
    7
    Migraine
         subjects affected / exposed
    18 / 1820 (0.99%)
    8 / 608 (1.32%)
         occurrences all number
    18
    8
    Paraesthesia
         subjects affected / exposed
    3 / 1820 (0.16%)
    2 / 608 (0.33%)
         occurrences all number
    3
    2
    Hypoaesthesia
         subjects affected / exposed
    2 / 1820 (0.11%)
    3 / 608 (0.49%)
         occurrences all number
    2
    3
    Sciatica
         subjects affected / exposed
    2 / 1820 (0.11%)
    3 / 608 (0.49%)
         occurrences all number
    2
    3
    Syncope
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Cervical root pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Nerve compression
         subjects affected / exposed
    1 / 1820 (0.05%)
    2 / 608 (0.33%)
         occurrences all number
    1
    2
    nerve root compression
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Balance disorder
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 1820 (0.05%)
    2 / 608 (0.33%)
         occurrences all number
    1
    2
    Lethargy
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Depression
         subjects affected / exposed
    21 / 1820 (1.15%)
    4 / 608 (0.66%)
         occurrences all number
    21
    4
    Anxiety
         subjects affected / exposed
    9 / 1820 (0.49%)
    4 / 608 (0.66%)
         occurrences all number
    9
    4
    Amnesia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Dysphasia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Facial spasm
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Post-traumatic headache
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Restless legs syndrome
         subjects affected / exposed
    1 / 1820 (0.05%)
    2 / 608 (0.33%)
         occurrences all number
    1
    2
    Tension headache
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Tunnel vision
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    facial palsy
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Hyperreflexia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 1820 (0.22%)
    1 / 608 (0.16%)
         occurrences all number
    4
    1
    Lymphadenopathy
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Leukopenia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Splenomegaly
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    14 / 1820 (0.77%)
    3 / 608 (0.49%)
         occurrences all number
    14
    3
    Otitis media
         subjects affected / exposed
    14 / 1820 (0.77%)
    6 / 608 (0.99%)
         occurrences all number
    14
    6
    Otitis externa
         subjects affected / exposed
    5 / 1820 (0.27%)
    0 / 608 (0.00%)
         occurrences all number
    5
    0
    Ear discomfort
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Deafness
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Labyrinthitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Vertigo
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Ear congestion
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Motion sickness
         subjects affected / exposed
    0 / 1820 (0.00%)
    2 / 608 (0.33%)
         occurrences all number
    0
    2
    Vertigo positional
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    13 / 1820 (0.71%)
    4 / 608 (0.66%)
         occurrences all number
    13
    4
    Dry eye
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Eyelid oedema
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Presbyopia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    2 / 1820 (0.11%)
    2 / 608 (0.33%)
         occurrences all number
    2
    2
    Blepharitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Blepharospasm
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Blindness
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Corneal lesion
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Eye inflammation
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Eye irritation
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Glaucoma
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Macular degeneration
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Eye swelling
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Asthenopia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis infective
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Eye discharge
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Iritis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    43 / 1820 (2.36%)
    14 / 608 (2.30%)
         occurrences all number
    43
    14
    Tooth disorder
         subjects affected / exposed
    39 / 1820 (2.14%)
    17 / 608 (2.80%)
         occurrences all number
    39
    17
    Abdominal pain
         subjects affected / exposed
    33 / 1820 (1.81%)
    12 / 608 (1.97%)
         occurrences all number
    33
    12
    Nausea
         subjects affected / exposed
    32 / 1820 (1.76%)
    20 / 608 (3.29%)
         occurrences all number
    32
    20
    Vomiting
         subjects affected / exposed
    14 / 1820 (0.77%)
    10 / 608 (1.64%)
         occurrences all number
    14
    10
    Gastrooesophageal reflux disease
         subjects affected / exposed
    15 / 1820 (0.82%)
    7 / 608 (1.15%)
         occurrences all number
    15
    7
    Dyspepsia
         subjects affected / exposed
    14 / 1820 (0.77%)
    6 / 608 (0.99%)
         occurrences all number
    14
    6
    Abdominal discomfort
         subjects affected / exposed
    6 / 1820 (0.33%)
    6 / 608 (0.99%)
         occurrences all number
    6
    6
    Gingival disorder
         subjects affected / exposed
    10 / 1820 (0.55%)
    4 / 608 (0.66%)
         occurrences all number
    10
    4
    Constipation
         subjects affected / exposed
    4 / 1820 (0.22%)
    4 / 608 (0.66%)
         occurrences all number
    4
    4
    Flatulence
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Dysphagia
         subjects affected / exposed
    4 / 1820 (0.22%)
    1 / 608 (0.16%)
         occurrences all number
    4
    1
    Food poisoning
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Gingival pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    sensitivity of teeth
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Tongue coated
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    aphthous stomatitis
         subjects affected / exposed
    2 / 1820 (0.11%)
    2 / 608 (0.33%)
         occurrences all number
    2
    2
    Gastritis
         subjects affected / exposed
    6 / 1820 (0.33%)
    1 / 608 (0.16%)
         occurrences all number
    6
    1
    Oral pain
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Abdominal distension
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Cheilosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Inguinal hernia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Lip swelling
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Proctalgia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Tooth deposit
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Pancreatitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Cholelithiasis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Hepatitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Biliary colic
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Cholecystitis acute
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Hepatic steatosis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    12 / 1820 (0.66%)
    2 / 608 (0.33%)
         occurrences all number
    12
    2
    Rash
         subjects affected / exposed
    12 / 1820 (0.66%)
    3 / 608 (0.49%)
         occurrences all number
    12
    3
    Urticaria
         subjects affected / exposed
    8 / 1820 (0.44%)
    0 / 608 (0.00%)
         occurrences all number
    8
    0
    Dermatitis
         subjects affected / exposed
    12 / 1820 (0.66%)
    0 / 608 (0.00%)
         occurrences all number
    12
    0
    Hyperhidrosis
         subjects affected / exposed
    4 / 1820 (0.22%)
    1 / 608 (0.16%)
         occurrences all number
    4
    1
    Dermatitis allergic
         subjects affected / exposed
    5 / 1820 (0.27%)
    1 / 608 (0.16%)
         occurrences all number
    5
    1
    Photosensitivity reaction
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Rash maculo-papular
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Rosacea
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Acrodermatitis
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Actinic keratosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Anhidrosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    6 / 1820 (0.33%)
    3 / 608 (0.49%)
         occurrences all number
    6
    3
    Erythema
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Hyperkeratosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Lichen planus
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Nail bed bleeding
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Rash macular
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Rash papular
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Swelling face
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Urticaria thermal
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Dermal cyst
         subjects affected / exposed
    0 / 1820 (0.00%)
    2 / 608 (0.33%)
         occurrences all number
    0
    2
    Dermatitis contact
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Skin lesion
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Acne cystic
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Alopecia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Ecchymosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Heat rash
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Ingrowing nail
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Skin fissures
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Skin ulcer
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Drug eruption
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Hypoaesthesia facial
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Neurodermatitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Cystitis
         subjects affected / exposed
    3 / 1820 (0.16%)
    4 / 608 (0.66%)
         occurrences all number
    3
    4
    Dysuria
         subjects affected / exposed
    3 / 1820 (0.16%)
    2 / 608 (0.33%)
         occurrences all number
    3
    2
    Nephrolithiasis
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Pollakiuria
         subjects affected / exposed
    1 / 1820 (0.05%)
    2 / 608 (0.33%)
         occurrences all number
    1
    2
    Renal colic
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Cystitis noninfective
         subjects affected / exposed
    0 / 1820 (0.00%)
    2 / 608 (0.33%)
         occurrences all number
    0
    2
    Polyuria
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Urogenital disorder
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Calculus urinary
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Haematuria
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Ureteric stenosis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Hyperthyroidism
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Hypothyroidism
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Thyroid disorder
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Basedow's disease
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Thyroiditis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    93 / 1820 (5.11%)
    31 / 608 (5.10%)
         occurrences all number
    93
    31
    Arthralgia
         subjects affected / exposed
    43 / 1820 (2.36%)
    18 / 608 (2.96%)
         occurrences all number
    43
    18
    Pain in extremity
         subjects affected / exposed
    28 / 1820 (1.54%)
    7 / 608 (1.15%)
         occurrences all number
    28
    7
    Myalgia
         subjects affected / exposed
    20 / 1820 (1.10%)
    7 / 608 (1.15%)
         occurrences all number
    20
    7
    Neck pain
         subjects affected / exposed
    24 / 1820 (1.32%)
    8 / 608 (1.32%)
         occurrences all number
    24
    8
    Musculoskeletal pain
         subjects affected / exposed
    23 / 1820 (1.26%)
    8 / 608 (1.32%)
         occurrences all number
    23
    8
    Bursitis
         subjects affected / exposed
    10 / 1820 (0.55%)
    2 / 608 (0.33%)
         occurrences all number
    10
    2
    Muscle spasms
         subjects affected / exposed
    9 / 1820 (0.49%)
    4 / 608 (0.66%)
         occurrences all number
    9
    4
    Musculoskeletal chest pain
         subjects affected / exposed
    10 / 1820 (0.55%)
    1 / 608 (0.16%)
         occurrences all number
    10
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    6 / 1820 (0.33%)
    3 / 608 (0.49%)
         occurrences all number
    6
    3
    Joint swelling
         subjects affected / exposed
    7 / 1820 (0.38%)
    1 / 608 (0.16%)
         occurrences all number
    7
    1
    Tendonitis
         subjects affected / exposed
    11 / 1820 (0.60%)
    2 / 608 (0.33%)
         occurrences all number
    11
    2
    Musculoskeletal discomfort
         subjects affected / exposed
    5 / 1820 (0.27%)
    0 / 608 (0.00%)
         occurrences all number
    5
    0
    Osteoarthritis
         subjects affected / exposed
    7 / 1820 (0.38%)
    0 / 608 (0.00%)
         occurrences all number
    7
    0
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Arthritis
         subjects affected / exposed
    2 / 1820 (0.11%)
    2 / 608 (0.33%)
         occurrences all number
    2
    2
    Bone pain
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Coccydynia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Gouty arthritis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Groin pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Osteopenia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Pain in jaw
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Sensation of heaviness
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Torticollis
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Plantar fasciitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    3 / 608 (0.49%)
         occurrences all number
    0
    3
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Tenosynovitis
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Chondropathy
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Costochondritis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Exostosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Flank pain
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Joint range of motion decreased
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Pseudarthrosis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Synovial cyst
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Toe deformity
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Fibromyalgia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Joint stiffness
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Mixed connective tissue disease
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    myopathy steroid
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Neck mass
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Scleroderma
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    304 / 1820 (16.70%)
    100 / 608 (16.45%)
         occurrences all number
    304
    100
    Sinusitis
         subjects affected / exposed
    59 / 1820 (3.24%)
    22 / 608 (3.62%)
         occurrences all number
    59
    22
    Gastrointestinal infection
         subjects affected / exposed
    31 / 1820 (1.70%)
    7 / 608 (1.15%)
         occurrences all number
    31
    7
    Urinary tract infection
         subjects affected / exposed
    29 / 1820 (1.59%)
    13 / 608 (2.14%)
         occurrences all number
    29
    13
    Bronchitis
         subjects affected / exposed
    46 / 1820 (2.53%)
    13 / 608 (2.14%)
         occurrences all number
    46
    13
    Upper respiratory tract infection
         subjects affected / exposed
    34 / 1820 (1.87%)
    19 / 608 (3.13%)
         occurrences all number
    34
    19
    Vaginal infection
         subjects affected / exposed
    23 / 1820 (1.26%)
    4 / 608 (0.66%)
         occurrences all number
    23
    4
    Pharyngitis
         subjects affected / exposed
    23 / 1820 (1.26%)
    8 / 608 (1.32%)
         occurrences all number
    23
    8
    Rhinitis
         subjects affected / exposed
    19 / 1820 (1.04%)
    7 / 608 (1.15%)
         occurrences all number
    19
    7
    Tooth infection
         subjects affected / exposed
    17 / 1820 (0.93%)
    2 / 608 (0.33%)
         occurrences all number
    17
    2
    Herpes virus infection
         subjects affected / exposed
    13 / 1820 (0.71%)
    1 / 608 (0.16%)
         occurrences all number
    13
    1
    Influenza
         subjects affected / exposed
    11 / 1820 (0.60%)
    4 / 608 (0.66%)
         occurrences all number
    11
    4
    Lower respiratory tract infection
         subjects affected / exposed
    9 / 1820 (0.49%)
    4 / 608 (0.66%)
         occurrences all number
    9
    4
    Tonsillitis
         subjects affected / exposed
    11 / 1820 (0.60%)
    4 / 608 (0.66%)
         occurrences all number
    11
    4
    Ear infection
         subjects affected / exposed
    7 / 1820 (0.38%)
    4 / 608 (0.66%)
         occurrences all number
    7
    4
    Fungal infection
         subjects affected / exposed
    12 / 1820 (0.66%)
    4 / 608 (0.66%)
         occurrences all number
    12
    4
    Pneumonia
         subjects affected / exposed
    7 / 1820 (0.38%)
    3 / 608 (0.49%)
         occurrences all number
    7
    3
    Laryngitis
         subjects affected / exposed
    4 / 1820 (0.22%)
    2 / 608 (0.33%)
         occurrences all number
    4
    2
    Respiratory tract infection
         subjects affected / exposed
    11 / 1820 (0.60%)
    1 / 608 (0.16%)
         occurrences all number
    11
    1
    Eye infection
         subjects affected / exposed
    5 / 1820 (0.27%)
    1 / 608 (0.16%)
         occurrences all number
    5
    1
    Localised infection
         subjects affected / exposed
    5 / 1820 (0.27%)
    2 / 608 (0.33%)
         occurrences all number
    5
    2
    Abscess limb
         subjects affected / exposed
    1 / 1820 (0.05%)
    1 / 608 (0.16%)
         occurrences all number
    1
    1
    Anal infection
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Arthritis infective
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Balanitis candida
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    8 / 1820 (0.44%)
    1 / 608 (0.16%)
         occurrences all number
    8
    1
    Cystitis
         subjects affected / exposed
    9 / 1820 (0.49%)
    5 / 608 (0.82%)
         occurrences all number
    9
    5
    Erysipelas
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Eyelid infection
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Furuncle
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    gingival infection
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Pyelonephritis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Rash pustular
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Subcutaneous abscess
         subjects affected / exposed
    3 / 1820 (0.16%)
    1 / 608 (0.16%)
         occurrences all number
    3
    1
    Tinea pedis
         subjects affected / exposed
    1 / 1820 (0.05%)
    2 / 608 (0.33%)
         occurrences all number
    1
    2
    Viral infection
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    adnexitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Chronic sinusitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Clostridial infection
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Groin abscess
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Pilonidal cyst
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Wound infection
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Hand fracture
         subjects affected / exposed
    2 / 1820 (0.11%)
    2 / 608 (0.33%)
         occurrences all number
    2
    2
    Onychomycosis
         subjects affected / exposed
    4 / 1820 (0.22%)
    0 / 608 (0.00%)
         occurrences all number
    4
    0
    Anogenital warts
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Oral candidiasis
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Kidney infection
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Scarlet fever
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Acute tonsillitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Borrelia infection
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Chlamydial infection
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Erythema migrans
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Gingival abscess
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Infected cyst
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Infected insect bite
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Mastitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Meningitis bacterial
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Pyoderma
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Sinusitis fungal
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Streptococcal infection
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Tracheobronchitis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Urosepsis
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    West Nile viral infection
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Genital herpes
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Infected skin ulcer
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Liver abscess
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Septic shock
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Tinea cruris
         subjects affected / exposed
    0 / 1820 (0.00%)
    2 / 608 (0.33%)
         occurrences all number
    0
    2
    Tracheitis
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    5 / 1820 (0.27%)
    3 / 608 (0.49%)
         occurrences all number
    5
    3
    Diabetes mellitus
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Diabetes mellitus non-insulin-dependent
         subjects affected / exposed
    2 / 1820 (0.11%)
    1 / 608 (0.16%)
         occurrences all number
    2
    1
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Gout
         subjects affected / exposed
    3 / 1820 (0.16%)
    0 / 608 (0.00%)
         occurrences all number
    3
    0
    Iron deficiency
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    3 / 1820 (0.16%)
    2 / 608 (0.33%)
         occurrences all number
    3
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Polydipsia
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    2 / 1820 (0.11%)
    0 / 608 (0.00%)
         occurrences all number
    2
    0
    Anorexia
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Underweight
         subjects affected / exposed
    1 / 1820 (0.05%)
    0 / 608 (0.00%)
         occurrences all number
    1
    0
    Impaired fasting glucose
         subjects affected / exposed
    0 / 1820 (0.00%)
    2 / 608 (0.33%)
         occurrences all number
    0
    2
    Overweight
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1
    Vitamin C deficiency
         subjects affected / exposed
    0 / 1820 (0.00%)
    1 / 608 (0.16%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2007
    Amendment 1 • Differentiated efficacy and safety objectives and defined a safety endpoint • Provided guidance on administration and follow-up for additional dosing with Engerix-B • Increased the sample size • Adjusted the age range to 18 - 55 years for the United States and Germany • Clarified the statistical tests for the efficacy description
    29 May 2007
    Amendment 2: • Added a EudraCT number • Removed the United States as a participating country • Provided additional details regarding stopping rules and the handling of confidential subject Information
    04 Feb 2008
    Amendment 3: • Increased the sample size • Updated and clarified the statistical considerations, comparisons, and determination of sample size • Clarified the severity grading of AEs
    08 May 2008
    Amendment 4: • Changed the anti-HBsAg testing assay from AUSAB AxSYM to the Hep B ECi assay
    03 Oct 2008
    Amendment 5: • Updated and clarified the objectives, statistical considerations, comparisons, and determination of sample size • Defined the end of the trial as the database lock for the study, which was selected due to the delay resulting from the change in the anti-HBsAg assay

    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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