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    Clinical Trial Results:
    Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

    Summary
    EudraCT number
    		 2014-001716-19
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    05 Mar 2018

    Results information
    Results version number
    		 v3(current)
    This version publication date
    20 Jan 2023
    First version publication date
    02 Aug 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Updated safety optional field

    Trial information

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    Trial identification
    Sponsor protocol code
    CYD15
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01374516
    WHO universal trial number (UTN)
    		 U1111-1116-4986
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    14, Espace Henry Vallée, Lyon , France, 69007
    Public contact
    Trial Transparency Team, Sanofi Pasteur , Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur , Contact-US@sanofi.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
    11 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy of CYD dengue vaccine after 3 vaccinations (one each at 0, 6 and 12 months) in preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due to any of the four serotypes in children and adolescents aged 9 to 16 years at the time of inclusion.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    08 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 72 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Colombia: 9743
    Country: Number of subjects enrolled
    Honduras: 2799
    Country: Number of subjects enrolled
    Brazil: 3548
    Country: Number of subjects enrolled
    Mexico: 3464
    Country: Number of subjects enrolled
    Puerto Rico: 1315
    Worldwide total number of subjects
    20869
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    9458
    Adolescents (12-17 years)
    11411
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled from 08 June 2011 to 16 March 2012 at 5 clinical centers in Brazil, 9 in Colombia, 1 in Honduras, 5 in Mexico, and 2 in Puerto Rico.

    Pre-assignment
    Screening details
    		 A total of 20869 subjects who met all of the inclusion and none of the exclusion criteria were enrolled and randomized in the study.

    Period 1
    Period 1 title
    Vaccination Phase (Up to 25 Months)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    The observer-blind design was chosen since the products have different aspects and could be recognized. The person who performed vaccinations knew which product was administered while neither the subject nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize any potential bias, the control group used the same route and schedule as the study vaccine.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CYD Dengue vaccine group
    Arm description
    		 Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    CYD Dengue vaccine
    Investigational medicinal product code
    323
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 3 injections. One each at 0, 6, and 12 months.

    Arm title
    		 Placebo group
    Arm description
    		 Subjects received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (NaCl)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 3 injections. One each at 0, 6, and 12 months.

    Number of subjects in period 1
    		CYD Dengue vaccine group Placebo group
    Started
    13920
    6949
    Completed
    13281
    6640
    Not completed
    639
    309
         Consent withdrawn by subject
    480
    240
         Adverse event, non-fatal
    3
    -
         Serious adverse event
    7
    9
         Lost to follow-up
    106
    46
         Protocol deviation
    43
    14
    Period 2
    Period 2 title
    Surveillance Expansion Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CYD Dengue Vaccine Group
    Arm description
    		 Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    CYD Dengue vaccine
    Investigational medicinal product code
    323
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 3 injections. One each at 0, 6, and 12 months.

    Arm title
    		 Placebo Group
    Arm description
    		 Subjects received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (NaCl)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 3 injections. One each at 0, 6, and 12 months.

    Number of subjects in period 2
    		CYD Dengue Vaccine Group Placebo Group
    Started
    13281
    6640
    Completed
    10932
    5387
    Not completed
    2349
    1253
         Consent withdrawn by subject
    1870
    986
         Serious adverse event
    20
    5
         Lost to follow-up
    73
    45
         Protocol deviation
    386
    217

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CYD Dengue vaccine group
    Reporting group description
    		 Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).

    Reporting group title
    Placebo group
    Reporting group description
    		 Subjects received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).

    Reporting group values
    		 CYD Dengue vaccine group Placebo group Total
    Number of subjects
    		 13920 6949 20869
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 6307 3151 9458
        Adolescents (12-17 years)
    		 7613 3798 11411
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.5 ( 2.14 ) 12.5 ( 2.13 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7048 3532 10580
        Male
    		 6872 3417 10289
    Region of Enrollment
    Units: Subjects
        Colombia
    		 6497 3246 9743
        Brazil
    		 2370 1178 3548
        Mexico
    		 2312 1152 3464
        Honduras
    		 1866 933 2799
        Puerto Rico
    		 875 440 1315

    End points

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    End points reporting groups
    Reporting group title
    CYD Dengue vaccine group
    Reporting group description
    		 Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).

    Reporting group title
    Placebo group
    Reporting group description
    		 Subjects received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
    Reporting group title
    CYD Dengue Vaccine Group
    Reporting group description
    		 Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).

    Primary: Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction (RT-PCR) and/or dengue non-structural (NS) protein 1 antigen enzyme-linked immunosorbent assay (ELISA). Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group. Number of symptomatic VCD cases were assessed in the Per-Protocol Analysis Set for Efficacy, defined as subjects who had no protocol deviations.
    End point type
    Primary
    End point timeframe
    28 days and up to 13 months post-injection 3
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    12574
    6261
    Units: Cases
        number (not applicable)
    176
    221
    Statistical analysis title
    		 Vaccine efficacy of the CYD dengue vaccine
    Statistical analysis description
    The statistical methodology was based on the use of the two-sided 95 percent (%) confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow & Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.
    Comparison groups
    CYD Dengue vaccine group v Placebo group
    Number of subjects included in analysis
    18835
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Vaccine Efficacy
    Point estimate
    60.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 52
         upper limit
    		 68

    Secondary: Number of Symptomatic VCD Cases Due to Any Serotype During the Active Phase Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Symptomatic VCD Cases Due to Any Serotype During the Active Phase Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group. Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included all subjects who received at least 1 injection.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 13 months post-injection 3
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    13914
    6940
    Units: Cases
        number (not applicable)
    277
    385
    Statistical analysis title
    		 Vaccine efficacy of the CYD dengue vaccine
    Statistical analysis description
    The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow & Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.
    Comparison groups
    CYD Dengue vaccine group v Placebo group
    Number of subjects included in analysis
    20854
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Vaccine Efficacy
    Point estimate
    64.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 58.7
         upper limit
    		 69.8

    Secondary: Number of Symptomatic VCD Cases Due to Any Serotype Occurring 28 Days Post-dose 1 Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Symptomatic VCD Cases Due to Any Serotype Occurring 28 Days Post-dose 1 Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group. Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included subjects who received at least 1 dose of study vaccine.
    End point type
    Secondary
    End point timeframe
    28 days post-injection 1 and up to 13 months post-injection 3
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    13914
    6940
    Units: Cases
        number (not applicable)
    273
    380
    Statistical analysis title
    		 Vaccine efficacy of CYD dengue vaccine
    Statistical analysis description
    The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.
    Comparison groups
    CYD Dengue vaccine group v Placebo group
    Number of subjects included in analysis
    20854
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Vaccine Efficacy
    Point estimate
    64.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 58.7
         upper limit
    		 69.9

    Secondary: Number of Symptomatic VCD Cases Due to Any Serotype Post-dose 2 Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Symptomatic VCD Cases Due to Any Serotype Post-dose 2 Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group. Number of symptomatic VCD cases were assessed in the Other Efficacy Analysis Set, which included subjects who received at least 2 doses of study vaccine.
    End point type
    Secondary
    End point timeframe
    28 days post-injection 2 and up to 13 months post-injection 3
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    13506
    6765
    Units: Cases
        number (not applicable)
    236
    306
    Statistical analysis title
    		 Vaccine efficacy of the CYD dengue vaccine
    Statistical analysis description
    The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.
    Comparison groups
    CYD Dengue vaccine group v Placebo group
    Number of subjects included in analysis
    20271
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Vaccine Efficacy
    Point estimate
    61.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 54.7
         upper limit
    		 68

    Secondary: Number of Symptomatic VCD Cases Meeting World Health Organization (WHO) Criteria Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Symptomatic VCD Cases Meeting World Health Organization (WHO) Criteria Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    Dengue hemorrhagic fever (DHF) cases were defined as number of subjects with at least one symptomatic VCD episode meeting the 1997 WHO criteria (a)Fever: acute onset, high (>= 38°C) and continuous, lasting 2 to 7days and (b)any of the pre-listed hemorrhagic manifestations and laboratory findings of thrombocytopenia (platelet <=100 x 109/L) and plasma leakage as shown by hemoconcentration (hematocrit increased by 20% or more) or pleural effusion (seen on Chest X-Ray [CXR]) and/or ascites and/ or hypoalbuminemia. DHF was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I subjects, usually in the form of skin and/or other hemorrhage. Number of WHO dengue hemorrhagic fever cases were assessed in the Safety Analysis Set, which included all subjects who received at least one dose of study vaccine. Here, ‘subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 0 to the end of study (up to 72 months)
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    12809
    6380
    Units: Cases
    number (not applicable)
        Due to Any of the 4 Serotypes: Any Grade
    7
    15
        Due to Any of the 4 Serotypes: Grade I
    0
    2
        Due to Any of the 4 Serotypes: Grade II
    7
    13
        Due to Any of the 4 Serotypes: Grade III
    0
    0
        Due to Any of the 4 Serotypes: Grade IV
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Symptomatic VCD Cases Meeting WHO Criteria During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Symptomatic VCD Cases Meeting WHO Criteria During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    The 1997 WHO criteria: a)Fever: acute onset, high (>=38°C) and continuous, for 2 to 7days and (b)any of the following: thrombocytopenia (platelet<=100 x 109/L) and plasma leakage as shown by hematocrit increased by 20% or more or pleural effusion and/or ascites and/or hypoalbuminemia. DHF was graded as follows: Grade I:Fever accompanied by non-specific constitutional symptoms; Grade II:Spontaneous bleeding in addition to the manifestations of Grade I subject, usually in the form of skin and/or other hemorrhages; Grade III:Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness; and Grade IV: Profound shock with undetectable blood pressure and pulse. Number of WHO DHF cases were assessed in the Full Analysis Set for Surveillance Expansion Period, which included all subjects who received at least 1 injection and accepted to be included in the Surveillance Expansion Period.
    End point type
    Secondary
    End point timeframe
    From consent to participate in the Surveillance Expansion Period to the end of study (up to 72 months)
    End point values
    		 CYD Dengue Vaccine Group Placebo Group
    Number of subjects analysed
    11063
    5430
    Units: Cases
    number (not applicable)
        Due to Any of the 4 Serotypes: Any Grade
    2
    0
        Due to Any of the 4 Serotypes: Grade I
    0
    0
        Due to Any of the 4 Serotypes: Grade II
    2
    0
        Due to Any of the 4 Serotypes: Grade III
    0
    0
        Due to Any of the 4 Serotypes: Grade IV
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Hospitalized VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Hospitalized VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    Hospitalized VCD cases were defined as VCD confirmed by dengue RT–PCR and/or dengue NS 1 ELISA in subjects with acute febrile illness (temperature >=38°C on at least 2 consecutive days) requiring hospitalization. Number of hospitalized dengue hemorrhagic fever cases were assessed in the Safety Analysis Set. Here, ‘subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 0 up to the end of study (up to 72 months)
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    12809
    6380
    Units: Cases
        number (not applicable)
    46
    71
    No statistical analyses for this end point

    Secondary: Number of Hospitalized VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Hospitalized VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    Hospitalized VCD cases were defined as VCD confirmed by dengue RT–PCR and/or dengue NS 1 ELISA in subjects with acute febrile illness (temperature >=38°C on at least 2 consecutive days) requiring hospitalization. Analysis was performed in the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    From consent to participate in the Surveillance Expansion Period to the end of study (up to 72 months)
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    13915
    6939
    Units: Cases
        number (not applicable)
    5
    2
    No statistical analyses for this end point

    Secondary: Number of Clinically Severe VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Clinically Severe VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    The Severity of VCD cases was assessed by an Independent Data monitoring Committee (IDMC) based on medical review of cases and any of following criteria: 1)Platelet count <=100000/μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2)Shock (pulse pressure <=20mmHg in child, or hypotension [<=90mmHg] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4)Encephalopathy i.e. unconsciousness or poor conscious state. Poor conscious state or unconsciousness must be supported by Glasgow Coma Scale (GCS) score 5)Liver impairment (AST >1000IU/L or prothrombin time [PT] International normalized ratio [INR] >1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine >= 1.5mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes. Analysis was performed in Safety Analysis Set. Here, ‘subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 0 to the end of study (up to 72 months)
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    12809
    6380
    Units: Cases
        number (not applicable)
    9
    16
    No statistical analyses for this end point

    Secondary: Number of Clinically Severe VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Clinically Severe VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    The severity of VCD cases was assessed by an IDMC based on a medical review of cases and any of the following criteria:-1) Platelet count <=100000 /μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure <= 20 mmHg in a child, or hypotension [<= 90 mmHg] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. Unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by GCS score 5) Liver impairment (AST >1000 IU/L or PT INR >1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine >= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes. Number of clinically severe VCD cases were assessed in the Full Analysis Set for Surveillance Expansion Period.
    End point type
    Secondary
    End point timeframe
    From consent to participate in the Surveillance Expansion Period to the end of study (up to 72 months)
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    11061
    5431
    Units: Cases
        number (not applicable)
    42
    34
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Antibody Titers >=10 1/Dil Against Each Dengue Virus Serotype Before and Following Injection (Inj.) With CYD Dengue Vaccine or Placebo

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    End point title
    		 Percentage of Subjects With Antibody Titers >=10 1/Dil Against Each Dengue Virus Serotype Before and Following Injection (Inj.) With CYD Dengue Vaccine or Placebo
    End point description
    Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (parental strains) were measured by the plaque reduction neutralization test (PRNT) in a pre-defined subset of subjects. Antibody titers against each dengue virus serotype strain were assessed in Full Analysis Set for Immunogenicity (FASI), which included a subset of subjects who received at least one dose of vaccine and had a blood sample drawn and result available after the dose. Here, ‘n’= subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Pre-injection 1, 28 days post Injections 2 and 3, 13 months and 60 months post-injection 3
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    1301
    643
    Units: Percentage of subjects
    number (not applicable)
        Dengue virus Serotype 1: Pre-Inj.1 (n=1297,641)
    72.8
    70.5
        Dengue virus Serotype 1: Post-Inj. 2 (n=1296,638)
    92.7
    71.8
        Dengue virus Serotype 1: Post-Inj. 3 (n=1291,640)
    94.9
    74.2
        Dengue virus Serotype 1;1yr Post-Inj.3(n=1261,629)
    85.6
    73.6
        Dengue virus Serotype 1;5yr Post-Inj.3(n=1038,508)
    90.0
    81.1
        Dengue virus Serotype 2; Pre-Inj. 1 (n=1299,640)
    76.1
    73.8
        Dengue virus Serotype 2; Post-Inj. 2 (n=1297,639)
    97.5
    75.1
        Dengue virus Serotype 2; Post-Inj. 3 (n=1291,640)
    98.5
    77.2
        Dengue virus Serotype 2;1yr Post-Inj.3(n=1264,629)
    94.1
    78.9
        Dengue virus Serotype 2;5yr Post-Inj.3(n=1038,508)
    93.5
    83.1
        Dengue virus Serotype 3; Pre-Inj. 1 (n=1300,639)
    76.5
    73.6
        Dengue virus Serotype 3; Post-Inj. 2 (n=1297,639)
    98.5
    75.7
        Dengue virus Serotype 3; Post-Inj. 3 (n=1291,640)
    98.4
    78.0
        Dengue virus Serotype 3;1yr Post-Inj.3(n=1265,629)
    92.7
    76.2
        Dengue virus Serotype 3;5yr Post-Inj.3(n=1038,508)
    95.4
    82.7
        Dengue virus Serotype 4; Pre-Inj. 1(n=1297,640)
    68.2
    65.0
        Dengue virus Serotype 4; Post-Inj. 2 (n=1295,637)
    96.9
    67.0
        Dengue virus Serotype 4; Post-Inj. 3 (n=1291,640)
    98.1
    68.9
        Dengue virus Serotype 4;1yr Post-Inj.3(n=1265,625)
    94.9
    69.0
        Dengue virus Serotype 4;5yr Post-Inj.3(n=1038,508)
    96.3
    78.9
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo

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    End point title
    		 Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
    End point description
    Geometric mean titers for each of the 4 dengue virus serotypes (parental strains) were assessed using the plaque reduction neutralization test (PRNT) in a pre-defined subset of subjects. Antibody titers against each dengue virus serotype strain were assessed in FASI, which included a subset of subjects who received at least one dose of vaccine and had a blood sample drawn and result available after the dose. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Pre-injection 1, 28 days post Injections 2 and 3, 13 months and 60 months post-injection 3
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    1301
    643
    Units: Titers (1/dilution)
    geometric mean (confidence interval 95%)
        Dengue virus Serotype 1: Pre-Inj.1 (n=1297,641)
    128 (112 to 145)
    119 (98.7 to 142)
        Dengue virus Serotype 1: Post-Inj. 2 (n=1296,638)
    458 (406 to 517)
    128 (106 to 154)
        Dengue virus Serotype 1: Post-Inj. 3 (n=1291,640)
    395 (353 to 441)
    121 (101 to 145)
        Dengue virus Serotype 1;1yr Post-Inj.3(n=1261,629)
    266 (234 to 302)
    146 (121 to 176)
        Dengue virus Serotype 1;5yr Post-Inj.3(n=1038,508)
    284 (252 to 321)
    210 (172 to 255)
        Dengue virus Serotype 2; Pre-Inj. 1 (n=1299,640)
    138 (123 to 156)
    115 (97.2 to 136)
        Dengue virus Serotype 2; Post-Inj. 2 (n=1297,639)
    622 (566 to 684)
    124 (104 to 148)
        Dengue virus Serotype 2; Post-Inj. 3 (n=1291,640)
    574 (528 to 624)
    129 (109 to 152)
        Dengue virus Serotype 2;1yr Post-Inj.3(n=1264,629)
    371 (336 to 409)
    145 (122 to 173)
        Dengue virus Serotype 2;5yr Post-Inj.3(n=1038,508)
    297 (269 to 328)
    201 (168 to 242)
        Dengue virus Serotype 3; Pre-Inj. 1 (n=1300,639)
    121 (108 to 136)
    114 (95.9 to 136)
        Dengue virus Serotype 3; Post-Inj. 2 (n=1297,639)
    556 (506 to 610)
    117 (98.3 to 139)
        Dengue virus Serotype 3; Post-Inj. 3 (n=1291,640)
    508 (465 to 555)
    124 (105 to 147)
        Dengue virus Serotype 3;1yr Post-Inj.3(n=1265,629)
    292 (263 to 325)
    137 (114 to 165)
        Dengue virus Serotype 3;5yr Post-Inj.3(n=1038,508)
    346 (313 to 383)
    224 (185 to 271)
        Dengue virus Serotype 4; Pre-Inj. 1(n=1297,640)
    43.6 (39.6 to 48.0)
    39.0 (33.9 to 44.7)
        Dengue virus Serotype 4; Post-Inj. 2 (n=1295,637)
    261 (242 to 281)
    40.9 (35.5 to 47.0)
        Dengue virus Serotype 4; Post-Inj. 3 (n=1291,640)
    241 (226 to 258)
    44.3 (38.6 to 50.8)
        Dengue virus Serotype 4;1yr Post-Inj.3(n=1265,625)
    174 (161 to 188)
    51.5 (44.3 to 59.8)
        Dengue virus Serotype 4;5yr Post-Inj.3(n=1038,508)
    144 (134 to 156)
    73.6 (63.4 to 85.5)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Solicited Injection Site Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Subjects With Solicited Injection Site Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions (9-11 years): Pain: incapacitating, unable to perform usual activities; Erythema and Swelling, >= 50 mm. Grade 3 Solicited injection site reactions (12-16 years): Pain: significant, prevents daily activity; Erythema and Swelling, >100 mm. Solicited injection site reactions were assessed in a subset of the Safety Analysis Set, which included all subjects who received at least one dose of study vaccine and who were evaluated for reactogenicity. Here, ‘number analyzed’ = subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Within 7 days after each and any injection
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    1333
    664
    Units: Subjects
    number (not applicable)
        Injection-site Pain (Post any inj.) (n=1328,658)
    650
    270
        Injection-site Erythema(Post-any inj.)(n=1328,658)
    83
    44
        Injection-site Swelling(Post-any inj.)(n=1328,658)
    77
    27
        Injection-site Pain (Post-inj. 1)(n=1326,657)
    430
    173
        Grade 3 Inj.-site Pain (Post-inj.1)(n=1326,657)
    11
    6
        Injection-site Erythema (Post-inj.1)(n=1326,656)
    55
    31
        Grade3 Inj.-site Erythema (Post-inj.1)(n=1326,656)
    0
    1
        Injection-site Swelling (Post-inj. 1)(n=1326,656)
    47
    18
        Grade3 Inj.-site Swelling (Post-inj.1)(n=1326,656)
    0
    1
        Injection-site Pain (Post-inj. 2)(n=1297,639)
    332
    105
        Grade3 Injection-site Pain(Post-inj.2)(n=1297,639)
    7
    0
        Injection-site Erythema (Post-inj.2) (n=1296,639)
    25
    11
        Grade3 Inj.-site Erythema (Post-inj.2)(n=1296,639)
    1
    0
        Injection-site Swelling (Post-inj. 2)(n=1296,639)
    25
    6
        Grade3 Inj.-site Swelling (Post-inj.2)(n=1296,639)
    0
    0
        Injection-site Pain (Post-inj. 3)(n=1279,630)
    288
    104
        Grade 3 Inj-site Pain (Post-inj. 3)(n=1279,630)
    11
    2
        Injection-site Erythema (Post-inj. 3)(n=1278,631)
    19
    10
        Grade3 Inj.-site Erythema (Post-inj.3)(n=1278,631)
    0
    0
        Injection-site Swelling (Post-inj. 3) (n=1279,631)
    20
    8
        Grade3 Inj.-site Swelling (Postinj.3) (n=1279,631)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Solicited Systemic Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo

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    End point title
    		 Number of Subjects With Solicited Systemic Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo
    End point description
    Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39°C; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity. Solicited systemic reactions were assessed in a subset of the Safety Analysis Set, which included all subjects who received at least one dose of study vaccine and who were evaluated for reactogenecity. Here, ‘n’ = subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Within 14 days after each and any injection
    End point values
    		 CYD Dengue vaccine group Placebo group
    Number of subjects analysed
    1333
    664
    Units: Subjects
    number (not applicable)
        Fever (Post any inj.) (n=1318,654)
    220
    123
        Headache (Post any inj.) (n=1328,659)
    727
    379
        Malaise (Post any inj.) (n=1328,659)
    536
    261
        Myalgia (Post any inj.) (n=1328,659)
    576
    267
        Asthenia (Post any inj.) (n=1328,659)
    496
    251
        Fever (Post-inj. 1) (n=1264,635)
    86
    42
        Grade 3 Fever (Post-inj. 1) (n=1264,635)
    21
    7
        Headache (Post-inj. 1) (n=1324,657)
    528
    273
        Grade 3 Headache (Post-inj. 1) (n=1324,657)
    67
    27
        Malaise (Post-inj. 1) (n=1323,657)
    324
    170
        Grade 3 Malaise (Post-inj. 1) (n=1323,657)
    32
    15
        Myalgia (Post-inj. 1) (n=1323,657)
    386
    180
        Grade 3 Myalgia (Post-inj. 1) (n=1323,657)
    29
    10
        Asthenia (Post-inj. 1) (n=1323,657)
    326
    148
        Grade 3 Asthenia (Post-inj. 1) (n=1323,657)
    36
    17
        Fever (Post-inj. 2) (n=1228,594)
    72
    42
        Grade 3 Fever (Post-inj. 2) (n=1228,594)
    10
    7
        Headache (Post-inj. 2) (n=1297,639)
    386
    182
        Grade 3 Headache (Post-inj. 2) (n=1297,639)
    27
    15
        Malaise (Post-inj. 2) (n=1298,639)
    270
    106
        Grade 3 Malaise (Post-inj. 2) (n=1298,639)
    17
    8
        Myalgia (Post-inj. 2) (n=1298,639)
    273
    101
        Grade 3 Myalgia (Post-inj. 2) (n=1298,639)
    21
    5
        Asthenia (Post-inj. 2) (n=1298,639)
    231
    105
        Grade 3 Asthenia (Post-inj. 2) (n=1298,639)
    24
    7
        Fever (Post-inj. 3) (n=1215,597)
    89
    52
        Grade 3 Fever (Post-inj. 3) (n=1215,597)
    13
    5
        Headache (Post-inj. 3) (n=1277,631)
    378
    158
        Grade 3 Headache (Post-inj. 3) (n=1277,631)
    33
    12
        Malaise (Post-inj. 3) (n=1277,631)
    246
    96
        Grade 3 Malaise (Post-inj. 3) (n=1277,631)
    18
    7
        Myalgia (Post-inj. 3) (n=1277,631)
    255
    116
        Grade 3 Myalgia (Post-inj. 3) (n=1277,631)
    19
    5
        Asthenia (Post-inj. 3) (n=1277,631)
    208
    110
        Grade 3 Asthenia (Post-inj. 3) (n=1277,631)
    17
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited adverse event (AE) data: collected from Day 0 (post-vaccination) up to 28 days after each vaccination. Solicited Reaction (SR) data: within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study.
    Adverse event reporting additional description
    Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    CYD Dengue Vaccine Group
    Reporting group description
    		 Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.

    Reporting group title
    Placebo Group
    Reporting group description
    		 subjects received 3 doses of placebo vaccine; one each at 0, 6, and 12 months.

    Serious adverse events
    		 CYD Dengue Vaccine Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1765 / 13915 (12.68%)
    911 / 6939 (13.13%)
         number of deaths (all causes)
    42
    27
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign Hydatidiform Mole
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Ovarian Tumour
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Pancreatic Neoplasm
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Giant Cell Tumour
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Sarcoma
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Neoplasm Malignant
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrosarcoma
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Myeloid Leukaemia
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Desmoid Tumour
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibroadenoma Of Breast
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma Of Skin
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's Disease
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondroma
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoma
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteosarcoma Metastatic
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Osteosarcoma Recurrent
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian Adenoma
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Germ Cell Teratoma Benign
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary Tumour Benign
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid Cancer
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Leiomyoma
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive Crisis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary Hypertension
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion Induced
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Induced Complete
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Caesarean Section
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity Surgery
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scoliosis Surgery
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgery
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia Repair
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abnormal Product Of Conception
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion
         subjects affected / exposed
    14 / 13915 (0.10%)
    6 / 6939 (0.09%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Complete
         subjects affected / exposed
    9 / 13915 (0.06%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Complicated
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Incomplete
         subjects affected / exposed
    22 / 13915 (0.16%)
    9 / 6939 (0.13%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Incomplete Complicated
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Missed
         subjects affected / exposed
    3 / 13915 (0.02%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Of Ectopic Pregnancy
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Spontaneous
         subjects affected / exposed
    48 / 13915 (0.34%)
    30 / 6939 (0.43%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Spontaneous Complete
         subjects affected / exposed
    8 / 13915 (0.06%)
    6 / 6939 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Spontaneous Complicated
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Spontaneous Incomplete
         subjects affected / exposed
    16 / 13915 (0.11%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Spontaneous Incomplete Complicated
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Threatened
         subjects affected / exposed
    14 / 13915 (0.10%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amniorrhexis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Antepartum Haemorrhage
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blighted Ovum
         subjects affected / exposed
    11 / 13915 (0.08%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cephalo-Pelvic Disproportion
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Incompetence
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication Of Delivery
         subjects affected / exposed
    4 / 13915 (0.03%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delivery
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eclampsia
         subjects affected / exposed
    5 / 13915 (0.04%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic Pregnancy
         subjects affected / exposed
    3 / 13915 (0.02%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failed Induction Of Labour
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    False Labour
         subjects affected / exposed
    39 / 13915 (0.28%)
    14 / 6939 (0.20%)
         occurrences causally related to treatment / all
    0 / 45
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foetal Distress Syndrome
         subjects affected / exposed
    1 / 13915 (0.01%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gestational Hypertension
         subjects affected / exposed
    12 / 13915 (0.09%)
    7 / 6939 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hellp Syndrome
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    High Risk Pregnancy
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperemesis Gravidarum
         subjects affected / exposed
    3 / 13915 (0.02%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-Uterine Death
         subjects affected / exposed
    1 / 13915 (0.01%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intrapartum Haemorrhage
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oligohydramnios
         subjects affected / exposed
    12 / 13915 (0.09%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Placental Insufficiency
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpartum Haemorrhage
         subjects affected / exposed
    8 / 13915 (0.06%)
    5 / 6939 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pre-Eclampsia
         subjects affected / exposed
    34 / 13915 (0.24%)
    23 / 6939 (0.33%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature Baby
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature Delivery
         subjects affected / exposed
    6 / 13915 (0.04%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature Labour
         subjects affected / exposed
    17 / 13915 (0.12%)
    6 / 6939 (0.09%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature Rupture Of Membranes
         subjects affected / exposed
    13 / 13915 (0.09%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature Separation Of Placenta
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prolonged Labour
         subjects affected / exposed
    1 / 13915 (0.01%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puerperal Pyrexia
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retained Placenta Or Membranes
         subjects affected / exposed
    2 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retained Products Of Conception
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured Ectopic Pregnancy
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stillbirth
         subjects affected / exposed
    6 / 13915 (0.04%)
    5 / 6939 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Threatened Labour
         subjects affected / exposed
    7 / 13915 (0.05%)
    9 / 6939 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Catheter Site Phlebitis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Device Intolerance
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Discomfort
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Malaise
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical Device Complication
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    9 / 13915 (0.06%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Inflammation
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Death
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Immune system disorders
    Allergy To Arthropod Sting
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic Reaction
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Antiphospholipid Syndrome
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Allergy
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Physical Assault
         subjects affected / exposed
    9 / 13915 (0.06%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sexual Abuse
         subjects affected / exposed
    7 / 13915 (0.05%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance Use
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Victim Of Crime
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Victim Of Homicide
         subjects affected / exposed
    5 / 13915 (0.04%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 1
    Victim Of Sexual Abuse
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balanitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bartholinitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Disorder
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Mass
         subjects affected / exposed
    4 / 13915 (0.03%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Pain
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coital Bleeding
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysfunctional Uterine Bleeding
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysmenorrhoea
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female Genital Tract Fistula
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gynaecomastia
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematocolpos
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematosalpinx
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Ovarian Cyst
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         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
    7 / 13915 (0.05%)
    5 / 6939 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cyst Ruptured
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Torsion
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovulation Pain
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Pain
         subjects affected / exposed
    3 / 13915 (0.02%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycystic Ovaries
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retrograde Menstruation
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular Disorder
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular Torsion
         subjects affected / exposed
    12 / 13915 (0.09%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Cyst
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Haemorrhage
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal Haemorrhage
         subjects affected / exposed
    3 / 13915 (0.02%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicocele
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval Haematoma
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenoidal Hypertrophy
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alveolitis Allergic
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    19 / 13915 (0.14%)
    17 / 6939 (0.24%)
         occurrences causally related to treatment / all
    1 / 24
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic Crisis
         subjects affected / exposed
    12 / 13915 (0.09%)
    7 / 6939 (0.10%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial Obstruction
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Septum Deviation
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Turbinate Hypertrophy
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Artery Stenosis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory Tract Haemorrhage
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Asthmaticus
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar Cyst
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar Hypertrophy
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal Behaviour
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Psychosis
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Stress Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adjustment Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorexia Nervosa
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I Disorder
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar Disorder
         subjects affected / exposed
    2 / 13915 (0.01%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed Suicide
         subjects affected / exposed
    2 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Conduct Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conversion Disorder
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dependence
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    18 / 13915 (0.13%)
    9 / 6939 (0.13%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression Suicidal
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dissociative Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Abuse
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Dependence
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional Drug Misuse
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional Self-Injury
         subjects affected / exposed
    6 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent Explosive Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    6 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obsessive Rumination
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia, Undifferentiated Type
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somatoform Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance Abuse
         subjects affected / exposed
    14 / 13915 (0.10%)
    9 / 6939 (0.13%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    19 / 13915 (0.14%)
    8 / 6939 (0.12%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune Hepatitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Stone
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    7 / 13915 (0.05%)
    6 / 6939 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    3 / 13915 (0.02%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    9 / 13915 (0.06%)
    13 / 6939 (0.19%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis Of Pregnancy
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Acute
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Toxic
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocholecystis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Investigation
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal Injury
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accident
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accident At Home
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accident At Work
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum Fracture
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adverse Event Following Immunisation
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal Bite
         subjects affected / exposed
    3 / 13915 (0.02%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod Sting
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Avulsion Fracture
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns Second Degree
         subjects affected / exposed
    6 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns Third Degree
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical Poisoning
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Injury
         subjects affected / exposed
    3 / 13915 (0.02%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Clavicle Fracture
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endotracheal Intubation Complication
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiphyseal Fracture
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Injury
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Penetration
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face Injury
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Bones Fracture
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    28 / 13915 (0.20%)
    11 / 6939 (0.16%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femur Fracture
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    21 / 13915 (0.15%)
    7 / 6939 (0.10%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign Body
         subjects affected / exposed
    1 / 13915 (0.01%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign Body In Eye
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital Injury
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun Shot Wound
         subjects affected / exposed
    24 / 13915 (0.17%)
    15 / 6939 (0.22%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 15
         deaths causally related to treatment / all
    0 / 12
    0 / 9
    Hand Fracture
         subjects affected / exposed
    5 / 13915 (0.04%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    16 / 13915 (0.11%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Humerus Fracture
         subjects affected / exposed
    6 / 13915 (0.04%)
    5 / 6939 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    3 / 13915 (0.02%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Injury
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Crushing Injury
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    4 / 13915 (0.03%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Traumatic Amputation
         subjects affected / exposed
    4 / 13915 (0.03%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    3 / 13915 (0.02%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus Lesion
         subjects affected / exposed
    3 / 13915 (0.02%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    6 / 13915 (0.04%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    12 / 13915 (0.09%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Muscle Injury
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve Injury
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open Wound
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal Laceration
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax Traumatic
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning Deliberate
         subjects affected / exposed
    15 / 13915 (0.11%)
    10 / 6939 (0.14%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-Traumatic Pain
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Complication
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Complication
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    8 / 13915 (0.06%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    108 / 13915 (0.78%)
    39 / 6939 (0.56%)
         occurrences causally related to treatment / all
    0 / 109
    0 / 39
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Skull Fracture
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Injury
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Injury
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Injury Cervical
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sports Injury
         subjects affected / exposed
    8 / 13915 (0.06%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab Wound
         subjects affected / exposed
    5 / 13915 (0.04%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Injury
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (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
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular Injury
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    5 / 13915 (0.04%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
         subjects affected / exposed
    7 / 13915 (0.05%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Traumatic Brain Injury
         subjects affected / exposed
    5 / 13915 (0.04%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Traumatic Fracture
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna Fracture
         subjects affected / exposed
    3 / 13915 (0.02%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulnar Nerve Injury
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Access Complication
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arteriovenous Malformation
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Septal Defect
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cryptorchism
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hereditary Spherocytosis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    0 / 13915 (0.00%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sickle Cell Trait
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wolff-Parkinson-White Syndrome
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Acute Disseminated Encephalomyelitis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Polyneuropathy
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arachnoid Cyst
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atonic Seizures
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar Syndrome
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complicated Migraine
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    21 / 13915 (0.15%)
    10 / 6939 (0.14%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Epilepsy
         subjects affected / exposed
    26 / 13915 (0.19%)
    8 / 6939 (0.12%)
         occurrences causally related to treatment / all
    0 / 86
    0 / 27
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Grand Mal Convulsion
         subjects affected / exposed
    2 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre Syndrome
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage Intracranial
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhagic Cerebral Infarction
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersomnia
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Encephalopathy
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic Generalised Epilepsy
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial Aneurysm
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine With Aura
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine Without Aura
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial Seizures
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-Traumatic Headache
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Epilepticus
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Migrainosus
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    6 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viith Nerve Paralysis
         subjects affected / exposed
    5 / 13915 (0.04%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 13915 (0.00%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Of Pregnancy
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplastic Anaemia
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic Thrombocytopenic Purpura
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    7 / 13915 (0.05%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoid Tissue Hyperplasia
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenic Purpura
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Tympanic Membrane Perforation
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Keratoconus
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual Impairment
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Adhesions
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    26 / 13915 (0.19%)
    9 / 6939 (0.13%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Lower
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Abdomen
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Haemorrhage
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    3 / 13915 (0.02%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    5 / 13915 (0.04%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Poisoning
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    12 / 13915 (0.09%)
    5 / 6939 (0.07%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Haemorrhagic
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingivitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia, Obstructive
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Functional Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 13915 (0.01%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable Bowel Syndrome
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malocclusion
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (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
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia, Obstructive
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices Oesophageal
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting In Pregnancy
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Atopic
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema Nodosum
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Henoch-Schonlein Purpura
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic Scar
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical Urticaria
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Erythematous
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Fissures
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous Nodule
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    4 / 13915 (0.03%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus Ureteric
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus Urethral
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus Urinary
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis Haemorrhagic
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lupus Nephritis
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nephritic Syndrome
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    15 / 13915 (0.11%)
    5 / 6939 (0.07%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Streptococcal Glomerulonephritis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    2 / 13915 (0.01%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Tubular Necrosis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial Nephritis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urogenital Haemorrhage
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Basedow's Disease
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothalamo-Pituitary Disorder
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (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
    Ankle Deformity
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    4 / 13915 (0.03%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiphysiolysis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (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 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Juvenile Arthritis
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee Deformity
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatic Fever
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid Arthritis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacroiliitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial Cyst
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic Lupus Erythematosus
         subjects affected / exposed
    2 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion Infected
         subjects affected / exposed
    1 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    6 / 13915 (0.04%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Neck
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Of Salivary Gland
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Oral
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Sinusitis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Tonsillitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoiditis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amniotic Cavity Infection
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic Dysentery
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anogenital Warts
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    261 / 13915 (1.88%)
    138 / 6939 (1.99%)
         occurrences causally related to treatment / all
    0 / 261
    0 / 138
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    3 / 13915 (0.02%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Infective
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asymptomatic Hiv Infection
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Infection
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bartholin's Abscess
         subjects affected / exposed
    2 / 13915 (0.01%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Abscess
         subjects affected / exposed
    4 / 13915 (0.03%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cellulitis
         subjects affected / exposed
    6 / 13915 (0.04%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    8 / 13915 (0.06%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    6 / 13915 (0.04%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    50 / 13915 (0.36%)
    35 / 6939 (0.50%)
         occurrences causally related to treatment / all
    0 / 50
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chikungunya Virus Infection
         subjects affected / exposed
    8 / 13915 (0.06%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chorioamnionitis
         subjects affected / exposed
    3 / 13915 (0.02%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Sinusitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Tonsillitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cutaneous Anthrax
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue Fever
         subjects affected / exposed
    101 / 13915 (0.73%)
    94 / 6939 (1.35%)
         occurrences causally related to treatment / all
    0 / 104
    0 / 94
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometritis
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometritis Decidual
         subjects affected / exposed
    3 / 13915 (0.02%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Infectious
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 13915 (0.01%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    External Ear Cellulitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Infection Toxoplasmal
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flavivirus Infection
         subjects affected / exposed
    3 / 13915 (0.02%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    34 / 13915 (0.24%)
    21 / 6939 (0.30%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Bacterial
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    3 / 13915 (0.02%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Bacterial Infection
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Infection
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Viral Infection
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital Infection Female
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genitourinary Tract Infection
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granuloma Inguinale
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1n1 Influenza
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiv Infection
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiv Infection Cdc Category A3
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helminthic Infection
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Viral
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster Ophthalmic
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Bites
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious Mononucleosis
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Myositis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leptospirosis
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    4 / 13915 (0.03%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastitis Postpartum
         subjects affected / exposed
    1 / 13915 (0.01%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis Bacterial
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis Viral
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mononucleosis Syndrome
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mumps
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycoplasma Infection
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    5 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Chronic
         subjects affected / exposed
    4 / 13915 (0.03%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media Chronic
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Mumps
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panencephalitis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Parasitic Gastroenteritis
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Inflammatory Disease
         subjects affected / exposed
    10 / 13915 (0.07%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal Abscess
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal Infection
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital Cellulitis
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar Abscess
         subjects affected / exposed
    2 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    3 / 13915 (0.02%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal Cyst
         subjects affected / exposed
    5 / 13915 (0.04%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    18 / 13915 (0.13%)
    13 / 6939 (0.19%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Bacterial
         subjects affected / exposed
    4 / 13915 (0.03%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Mycoplasmal
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Infection
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    6 / 13915 (0.04%)
    4 / 6939 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpartum Sepsis
         subjects affected / exposed
    4 / 13915 (0.03%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    10 / 13915 (0.07%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    7 / 13915 (0.05%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal Abscess
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scarlet Fever
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary Syphilis
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Infection
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Infection
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous Abscess
         subjects affected / exposed
    13 / 13915 (0.09%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syphilis
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    2 / 13915 (0.01%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis Bacterial
         subjects affected / exposed
    2 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Abscess
         subjects affected / exposed
    6 / 13915 (0.04%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxoplasmosis
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Typhoid Fever
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 13915 (0.02%)
    3 / 6939 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    118 / 13915 (0.85%)
    59 / 6939 (0.85%)
         occurrences causally related to treatment / all
    0 / 127
    0 / 69
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal Infection
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    3 / 13915 (0.02%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Cardiomyopathy
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    10 / 13915 (0.07%)
    7 / 6939 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visceral Leishmaniasis
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval Abscess
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    5 / 13915 (0.04%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 13915 (0.00%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    0 / 13915 (0.00%)
    2 / 6939 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    2 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 13915 (0.01%)
    0 / 6939 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 Diabetes Mellitus
         subjects affected / exposed
    1 / 13915 (0.01%)
    1 / 6939 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CYD Dengue Vaccine Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1038 / 13915 (7.46%)
    515 / 6939 (7.42%)
    Nervous system disorders
    Headache
         subjects affected / exposed [1]
    753 / 1333 (56.49%)
    388 / 664 (58.43%)
         occurrences all number
    1385
    652
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed [2]
    500 / 1333 (37.51%)
    253 / 664 (38.10%)
         occurrences all number
    771
    366
    Injection Site Erythema
         subjects affected / exposed [3]
    83 / 1333 (6.23%)
    44 / 664 (6.63%)
         occurrences all number
    99
    52
    Injection Site Pain
         subjects affected / exposed [4]
    650 / 1333 (48.76%)
    270 / 664 (40.66%)
         occurrences all number
    1056
    384
    Injection Site Swelling
         subjects affected / exposed [5]
    77 / 1333 (5.78%)
    27 / 664 (4.07%)
         occurrences all number
    92
    32
    Malaise
         subjects affected / exposed [6]
    539 / 1333 (40.44%)
    264 / 664 (39.76%)
         occurrences all number
    853
    383
    Pyrexia
         subjects affected / exposed [7]
    238 / 1333 (17.85%)
    127 / 664 (19.13%)
         occurrences all number
    270
    142
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed [8]
    578 / 1333 (43.36%)
    267 / 664 (40.21%)
         occurrences all number
    921
    400
    Infections and infestations
    Influenza
         subjects affected / exposed [9]
    76 / 1333 (5.70%)
    37 / 664 (5.57%)
         occurrences all number
    80
    40
    Nasopharyngitis
         subjects affected / exposed [10]
    150 / 1333 (11.25%)
    60 / 664 (9.04%)
         occurrences all number
    163
    70
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were assessed in a subset of subjects in each group, in accordance with the protocol.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2011
    Major modifications included Venezuela declined its participation, clarified efficacy during the Active Phase, end of febrile episode was further clarified, frequency of contact during the Hospital Phase was increased to 1 every 3 months, potential manifestations of severity were updated, clarified that the safety surveillance was conducted by the Principal Investigators, transaminases were available to add in the assessment of the severity of confirmed dengue cases, clarification on the reporting of SAEs during the Active Phase and the Hospital Phase, and clarification on subjects who discontinued from vaccination or trial and their continuation in the study for surveillance purposes.
    03 Aug 2011
    Clarified collection periods of acute and convalescent samples, SAE reporting period was extended throughout the entire study, clarified that laboratory staff was blinded to treatment allocation, age stratification was clarified (9 to 11 years and 12 to 16 years), updated time window of assessment of serious viscerotropic disease, and introduced the use of the WHO Verbal Autopsy Questionnaire.
    29 May 2013
    Modified the testing algorithm for the virological-confirmation of dengue cases to maximize the likelihood of detecting dengue cases, updated and clarified text of secondary objectives as it relates to the assessment of the CYD dengue vaccine in preventing symptomatic virologically-confirmed cases, Hospital Phase was extended by 2 years to allow a 5 year follow-up period after the last vaccination, "Other Objectives" section was added, and included re-consenting of subjects for the 2-year extension and for additional testing to identify the dengue virus.
    25 Jan 2015
    An enhanced surveillance system (the SEP) following 1 year or more of the Hospital Phase was implemented, the trial's objectives and endpoints were updated to be consistent with additional study goals, the management of suspected dengue cases was modified.
    20 Jun 2016
    Section 5.1.1 “Trial Design” was updated to add the anti Zika antibody detection, the detection of Zika infection in febrile episodes occurring from start of 2013 (retrospectively) until the end of the trial, in order to differentiate Zika cases from Dengue cases; and the Zika virus sequencing on Zika infection positive samples, three objectives were added in Section 2.3. “Other Objectives”, the definition of clinically severe dengue cases was clarified, endpoints corresponding to the 3 additional objectives were added, in Section 5.1.4, the use of the blood samples for anti-Zika antibody response evaluation was added, in Section 12.1.3. “Statistical Methods for other objectives” a new subsection (Relationship between Dengue and Zika) was added.

    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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