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    Clinical Trial Results:
    A Phase IIIB, non-randomized, open-label, multicountry, multi-centric cross-vaccination study to evaluate the safety of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine when administered intramuscularly on a two-dose schedule to subjects who previously received placebo in ZOSTER-006 and ZOSTER-022 studies.

    Summary
    EudraCT number
    		 2015-000965-30
    Trial protocol
    		 FI   EE   CZ   GB   DE   ES   FR   IT  
    Global end of trial date
    15 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2020
    First version publication date
    13 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    204486
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02690207
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety, in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAE) and potential Immune Mediated Disease (pIMD) in all subjects, following administration of each dose of the HZ/su vaccine.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of the vaccines, with appropriate medical treatment readily available in case of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 196
    Country: Number of subjects enrolled
    Brazil: 356
    Country: Number of subjects enrolled
    Canada: 486
    Country: Number of subjects enrolled
    Czech Republic: 442
    Country: Number of subjects enrolled
    Estonia: 786
    Country: Number of subjects enrolled
    Finland: 1132
    Country: Number of subjects enrolled
    France: 327
    Country: Number of subjects enrolled
    Germany: 529
    Country: Number of subjects enrolled
    Hong Kong: 223
    Country: Number of subjects enrolled
    Italy: 85
    Country: Number of subjects enrolled
    Japan: 220
    Country: Number of subjects enrolled
    Korea, Republic of: 312
    Country: Number of subjects enrolled
    Mexico: 610
    Country: Number of subjects enrolled
    Spain: 490
    Country: Number of subjects enrolled
    Sweden: 684
    Country: Number of subjects enrolled
    Taiwan: 674
    Country: Number of subjects enrolled
    United Kingdom: 331
    Country: Number of subjects enrolled
    United States: 804
    Worldwide total number of subjects
    8687
    EEA total number of subjects
    4806
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2326
    From 65 to 84 years
    5574
    85 years and over
    787

    Subject disposition

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    Recruitment
    Recruitment details
    		 Potentially eligible subjects who received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies were enrolled in this study.

    Pre-assignment
    Screening details
    		 8687 subjects were enrolled in this study and received Herpes Zoster sub-unit vaccine. Of these, 8434 subjects completed the trial and 253 subjects withdrew.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is not applicable as there was no blinding in this study (open-label)

    Arms
    Arm title
    		 HZ/su Group
    Arm description
    		 Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    HZ/su Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of vaccine (0.5 mL each) were administered according to a 0,2-month vaccination schedule.

    Number of subjects in period 1
    		HZ/su Group
    Started
    8687
    Completed
    8434
    Not completed
    253
         Consent withdrawn by subject
    46
         Migrated/moved from study area
    5
         Other reasons for withdrawal
    23
         Suspected HZ Episode
    1
         Serious adverse event
    110
         Lost to follow-up
    48
         Non-serious Adverse Event
    18
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HZ/su Group
    Reporting group description
    		 Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm

    Reporting group values
    		 HZ/su Group Total
    Number of subjects
    		 8687 8687
    Age Categorical
    Units: Participants
        Age 18-64 years
    		 2326 2326
        Age 65-84 years
    		 5574 5574
        Age 85 years and over
    		 787 787
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.6 ( 9.4 ) -
    Sex/Gender, Customized
    Units: Participants
        Female
    		 5254 5254
        Male
    		 3433 3433
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage/ African American
    		 72 72
        American Indian or Alaskan Native
    		 7 7
        Asian-Central/South Asian Heritage
    		 5 5
        Asian-East Asian Heritage
    		 1202 1202
        Asian-Japanese Heritage
    		 254 254
        Asian-South East Asian Heritage
    		 12 12
        Native Hawaiian or Other Pacific Islander
    		 3 3
        White-Arabic/North African Heritage
    		 47 47
        White-Caucasian / European Heritage
    		 6361 6361
        Mixed origin
    		 724 724

    End points

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    End points reporting groups
    Reporting group title
    HZ/su Group
    Reporting group description
    		 Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm

    Primary: Number of subjects with Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

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    End point title
    		 Number of subjects with Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [1]
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related=AE assessed by the investigator as related to the vaccination. This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available
    End point type
    Primary
    End point timeframe
    During 30 days (Days 0-29) after any vaccination (across doses)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive, hence no statistical analyses were available.
    End point values
    		 HZ/su Group
    Number of subjects analysed
    8687
    Units: Subjects
        Any AE(s)
    5175
        Grade 3 AE(s)
    963
        Related AE(s)
    4422
    No statistical analyses for this end point

    Primary: Number of subjects with Any and Related Serious Adverse Events (SAEs)

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    End point title
    		 Number of subjects with Any and Related Serious Adverse Events (SAEs) [2]
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related=SAE assessed by the investigator as related to the vaccination. This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available
    End point type
    Primary
    End point timeframe
    From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive, hence no statistical analyses were available.
    End point values
    		 HZ/su Group
    Number of subjects analysed
    8687
    Units: Subjects
        Any SAE(s)
    734
        Related SAE(s)
    2
    No statistical analyses for this end point

    Primary: Number of subjects with Any and Related Potential Immune Mediated Diseases (pIMDs)

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    End point title
    		 Number of subjects with Any and Related Potential Immune Mediated Diseases (pIMDs) [3]
    End point description
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs=pIMDs assessed by the investigator as related to the vaccination. This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available
    End point type
    Primary
    End point timeframe
    From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive, hence no statistical analyses were available.
    End point values
    		 HZ/su Group
    Number of subjects analysed
    8687
    Units: Subjects
        Any pIMD(s)
    62
        Related pIMD(s)
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with at least one suspected Herpes Zoster (HZ) case(s)

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    End point title
    		 Number of subjects with at least one suspected Herpes Zoster (HZ) case(s)
    End point description
    A suspected case of HZ was defined as a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations). Clinically confirmed HZ episode is suspected HZ episode confirmed by the Investigator/Delegate This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available
    End point type
    Secondary
    End point timeframe
    From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
    End point values
    		 HZ/su Group
    Number of subjects analysed
    8687
    Units: Subjects
        HZ episode
    30
        Suspected HZ episode only
    8
        Clinically confirmed HZ episode
    22
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    HZ/su Group
    Reporting group description
    		 Subjects received herpes zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm

    Serious adverse events
    		 HZ/su Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    734 / 8687 (8.45%)
         number of deaths (all causes)
    107
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acoustic neuroma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    B precursor type acute leukaemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast cancer
         subjects affected / exposed
    12 / 8687 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    Cancer pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac myxoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Colon adenoma
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Colon cancer
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Colon cancer metastatic
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Ganglioneuroma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastric neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hodgkin’s disease
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypopharyngeal neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Insulinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lip neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Marginal zone lymphoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastases to lung
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Metastatic neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ovarian cancer recurrent
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Penile cancer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Prostate cancer
         subjects affected / exposed
    9 / 8687 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal cancer
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Renal cell carcinoma recurrent
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Uterine cancer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aortic rupture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Arterial rupture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Embolism venous
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Haematoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    10 / 8687 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Intermittent claudication
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Poor peripheral circulation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subclavian steal syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Accidental death
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Adverse drug reaction
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest discomfort
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest pain
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 6
    General physical health deterioration
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Oedema
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Pyrexia
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Vascular stent stenosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cystocele
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Menorrhagia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectocele
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Asthma
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    Dyspnoea
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Haemoptysis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Interstitial lung disease
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    Pneumonia aspiration
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pulmonary oedema
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    Respiratory distress
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory failure
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Sinus perforation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Blood potassium decreased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ankle fracture
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Cardiac valve rupture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Chest injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Concussion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Contusion
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Femur fracture
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Head injury
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    Hip fracture
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Kidney contusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Limb injury
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Liver contusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple fractures
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Multiple injuries
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Patella fracture
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural swelling
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Radiation proctitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road traffic accident
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    Seroma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Shunt occlusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin laceration
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Spinal column injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tibia fracture
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Transfusion-related acute lung injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Traumatic liver injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ulnar nerve injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viith nerve injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wrist fracture
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Left ventricle outflow tract obstruction
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Type v hyperlipidaemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    18 / 8687 (0.21%)
         occurrences causally related to treatment / all
    0 / 19
         deaths causally related to treatment / all
    0 / 2
    Angina pectoris
         subjects affected / exposed
    12 / 8687 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    25 / 8687 (0.29%)
         occurrences causally related to treatment / all
    0 / 27
         deaths causally related to treatment / all
    0 / 2
    Atrial flutter
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bradycardia
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 8
    Cardiac failure
         subjects affected / exposed
    28 / 8687 (0.32%)
         occurrences causally related to treatment / all
    0 / 32
         deaths causally related to treatment / all
    0 / 17
    Cardiac failure acute
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    14 / 8687 (0.16%)
         occurrences causally related to treatment / all
    0 / 14
         deaths causally related to treatment / all
    0 / 7
    Cardiac ventricular thrombosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiogenic shock
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiomegaly
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    9 / 8687 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Mitral valve incompetence
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Mitral valve stenosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    18 / 8687 (0.21%)
         occurrences causally related to treatment / all
    0 / 18
         deaths causally related to treatment / all
    0 / 7
    Myocardial ischaemia
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Parasystole
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Pericarditis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Basal ganglia haemorrhage
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Carotid artery stenosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Carotid sinus syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebellar ataxia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    Cerebral infarction
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    Cerebral ischaemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    14 / 8687 (0.16%)
         occurrences causally related to treatment / all
    0 / 14
         deaths causally related to treatment / all
    0 / 3
    Coma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Dizziness
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Epilepsy
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Loss of consciousness
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myoclonus
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neuroglycopenia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Petit mal epilepsy
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radicular pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    11 / 8687 (0.13%)
         occurrences causally related to treatment / all
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    Vith nerve paralysis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Senile dementia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vertigo
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Vertigo positional
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Macular hole
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal detachment
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    Gastritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    Large intestinal obstruction
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Large intestine polyp
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mallory-weiss syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Oesophageal perforation
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Spigelian hernia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tooth impacted
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Volvulus
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cholecystitis
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic haematoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash pruritic
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    Bladder obstruction
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    End stage renal disease
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Glomerulonephritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nephrolithiasis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prerenal failure
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Renal impairment
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Toxic goitre
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Back pain
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc compression
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Joint effusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    15 / 8687 (0.17%)
         occurrences causally related to treatment / all
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    Osteolysis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoporosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Periarthritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendonitis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacterial infection
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bone tuberculosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Erysipelas
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Escherichia pyelonephritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric ulcer helicobacter
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Herpes simplex
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Infectious pleural effusion
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    9 / 8687 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    Joint abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver abscess
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Necrotising fasciitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis externa
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraoesophageal abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pathogen resistance
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    54 / 8687 (0.62%)
         occurrences causally related to treatment / all
    0 / 58
         deaths causally related to treatment / all
    0 / 4
    Pneumonia haemophilus
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    10 / 8687 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Systemic candida
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Tooth abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    17 / 8687 (0.20%)
         occurrences causally related to treatment / all
    0 / 17
         deaths causally related to treatment / all
    0 / 1
    Urosepsis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vulval abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gout
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Latent autoimmune diabetes in adults
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HZ/su Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5101 / 8687 (58.72%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Cholesteatoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Colon adenoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Melanocytic naevus
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Skin cancer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Skin papilloma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Essential hypertension
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Flushing
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Haematoma
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Hot flush
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Hypertension
         subjects affected / exposed
    20 / 8687 (0.23%)
         occurrences all number
    21
    Hypertensive crisis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Hypotension
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Pallor
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Peripheral venous disease
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Thrombophlebitis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Thrombophlebitis superficial
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Thrombosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Varicose vein
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    General disorders and administration site conditions
    Administration site discomfort
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Administration site erythema
         subjects affected / exposed
    20 / 8687 (0.23%)
         occurrences all number
    21
    Administration site oedema
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Administration site pain
         subjects affected / exposed
    50 / 8687 (0.58%)
         occurrences all number
    57
    Administration site pruritus
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Administration site swelling
         subjects affected / exposed
    13 / 8687 (0.15%)
         occurrences all number
    13
    Administration site warmth
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Application site burn
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Asthenia
         subjects affected / exposed
    74 / 8687 (0.85%)
         occurrences all number
    81
    Axillary pain
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Chest discomfort
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Chest pain
         subjects affected / exposed
    13 / 8687 (0.15%)
         occurrences all number
    14
    Chills
         subjects affected / exposed
    319 / 8687 (3.67%)
         occurrences all number
    366
    Cyst
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Discomfort
         subjects affected / exposed
    15 / 8687 (0.17%)
         occurrences all number
    16
    Facial pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    384 / 8687 (4.42%)
         occurrences all number
    448
    Feeling abnormal
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences all number
    7
    Feeling cold
         subjects affected / exposed
    47 / 8687 (0.54%)
         occurrences all number
    52
    Feeling hot
         subjects affected / exposed
    29 / 8687 (0.33%)
         occurrences all number
    31
    General physical health deterioration
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences all number
    7
    Hyperthermia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Inflammation
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Influenza like illness
         subjects affected / exposed
    65 / 8687 (0.75%)
         occurrences all number
    74
    Injection site bruising
         subjects affected / exposed
    14 / 8687 (0.16%)
         occurrences all number
    14
    Injection site discomfort
         subjects affected / exposed
    13 / 8687 (0.15%)
         occurrences all number
    14
    Injection site eczema
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Injection site erythema
         subjects affected / exposed
    1311 / 8687 (15.09%)
         occurrences all number
    1717
    Injection site exfoliation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Injection site extravasation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Injection site haematoma
         subjects affected / exposed
    13 / 8687 (0.15%)
         occurrences all number
    13
    Injection site haemorrhage
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Injection site hyperaesthesia
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences all number
    8
    Injection site hypersensitivity
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Injection site hypertrophy
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Injection site hypoaesthesia
         subjects affected / exposed
    9 / 8687 (0.10%)
         occurrences all number
    9
    Injection site induration
         subjects affected / exposed
    64 / 8687 (0.74%)
         occurrences all number
    73
    Injection site inflammation
         subjects affected / exposed
    85 / 8687 (0.98%)
         occurrences all number
    94
    Injection site irritation
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Injection site joint discomfort
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    2
    Injection site joint pain
         subjects affected / exposed
    24 / 8687 (0.28%)
         occurrences all number
    25
    Injection site mass
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    7
    Injection site movement impairment
         subjects affected / exposed
    13 / 8687 (0.15%)
         occurrences all number
    13
    Injection site nodule
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Injection site oedema
         subjects affected / exposed
    23 / 8687 (0.26%)
         occurrences all number
    24
    Injection site pain
         subjects affected / exposed
    3173 / 8687 (36.53%)
         occurrences all number
    4579
    Injection site paraesthesia
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Injection site pruritus
         subjects affected / exposed
    248 / 8687 (2.85%)
         occurrences all number
    299
    Injection site rash
         subjects affected / exposed
    46 / 8687 (0.53%)
         occurrences all number
    51
    Injection site reaction
         subjects affected / exposed
    24 / 8687 (0.28%)
         occurrences all number
    27
    Injection site scab
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Injection site swelling
         subjects affected / exposed
    928 / 8687 (10.68%)
         occurrences all number
    1194
    Injection site urticaria
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Injection site vesicles
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Injection site warmth
         subjects affected / exposed
    177 / 8687 (2.04%)
         occurrences all number
    211
    Malaise
         subjects affected / exposed
    226 / 8687 (2.60%)
         occurrences all number
    258
    Nodule
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Oedema peripheral
         subjects affected / exposed
    10 / 8687 (0.12%)
         occurrences all number
    10
    Pain
         subjects affected / exposed
    183 / 8687 (2.11%)
         occurrences all number
    213
    Peripheral swelling
         subjects affected / exposed
    15 / 8687 (0.17%)
         occurrences all number
    16
    Polyp
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1039 / 8687 (11.96%)
         occurrences all number
    1261
    Sluggishness
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Swelling
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Temperature intolerance
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Temperature regulation disorder
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences all number
    8
    Tenderness
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Thirst
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Vaccination site erythema
         subjects affected / exposed
    51 / 8687 (0.59%)
         occurrences all number
    58
    Vaccination site induration
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Vaccination site inflammation
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Vaccination site irritation
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Vaccination site mass
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Vaccination site oedema
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences all number
    8
    Vaccination site pain
         subjects affected / exposed
    135 / 8687 (1.55%)
         occurrences all number
    156
    Vaccination site paraesthesia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Vaccination site pruritus
         subjects affected / exposed
    11 / 8687 (0.13%)
         occurrences all number
    12
    Vaccination site rash
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    2
    Vaccination site swelling
         subjects affected / exposed
    37 / 8687 (0.43%)
         occurrences all number
    40
    Vaccination site warmth
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences all number
    7
    Vessel puncture site bruise
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Injection site joint swellin
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Food allergy
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Hypersensitivity
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Multiple allergies
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Reaction to food additive
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Seasonal allergy
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Breast cyst
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Breast enlargement
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Breast pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Pelvic pain
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Prostatitis
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Vulvar erosion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Allergic bronchitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Asthma
         subjects affected / exposed
    9 / 8687 (0.10%)
         occurrences all number
    10
    Bronchiectasis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Bronchitis chronic
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Bronchospasm
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Catarrh
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Cough
         subjects affected / exposed
    91 / 8687 (1.05%)
         occurrences all number
    96
    Dysphonia
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Dyspnoea
         subjects affected / exposed
    9 / 8687 (0.10%)
         occurrences all number
    9
    Dyspnoea exertional
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    11 / 8687 (0.13%)
         occurrences all number
    13
    Laryngeal pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Lower respiratory tract congestion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Nasal congestion
         subjects affected / exposed
    18 / 8687 (0.21%)
         occurrences all number
    19
    Nasal disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Nasal obstruction
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Oropharyngeal pain
         subjects affected / exposed
    52 / 8687 (0.60%)
         occurrences all number
    57
    Pharyngeal swelling
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Productive cough
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences all number
    7
    Pulmonary congestion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Respiratory disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Rhinitis allergic
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Rhinorrhoea
         subjects affected / exposed
    19 / 8687 (0.22%)
         occurrences all number
    20
    Sinus congestion
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Sinus pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Sneezing
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Sputum discoloured
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Depressed mood
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Depression
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Generalised anxiety disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    32 / 8687 (0.37%)
         occurrences all number
    34
    Irritability
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    2
    Listless
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Middle insomnia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Restlessness
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Sleep disorder
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blood iron decreased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blood pressure decreased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blood pressure diastolic increased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blood pressure increased
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Blood triglycerides increased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blood urea decreased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Body temperature increased
         subjects affected / exposed
    76 / 8687 (0.87%)
         occurrences all number
    86
    Cardiac murmur
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Haemoglobin decreased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Heart rate increased
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    2
    Animal bite
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Arthropod bite
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences all number
    8
    Arthropod sting
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Bone contusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    11 / 8687 (0.13%)
         occurrences all number
    11
    Deafness traumatic
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Ear injury
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Epicondylitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Face injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Facial bones fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    11 / 8687 (0.13%)
         occurrences all number
    12
    Foot fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Head injury
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Heat stroke
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Joint injury
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Ligament rupture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Ligament sprain
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Limb injury
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Muscle rupture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Muscle strain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Post procedural complication
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Procedural pain
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Radius fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Skin abrasion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Skin injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Skin laceration
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Snake bite
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Soft tissue injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    2
    Splinter
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Sternal fracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Subdural haematoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tendon injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tendon rupture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    2
    Tooth fracture
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Tooth injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Traumatic arthritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Traumatic haematoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Wound
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Wrist fracture
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Arrhythmia
         subjects affected / exposed
    9 / 8687 (0.10%)
         occurrences all number
    11
    Atrial fibrillation
         subjects affected / exposed
    11 / 8687 (0.13%)
         occurrences all number
    11
    Atrioventricular block
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Cardiac failure chronic
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Cardiovascular disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Chronic left ventricular failure
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Dilatation ventricular
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Extrasystoles
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Hypertensive heart disease
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Mitral valve incompetence
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Mitral valve prolapse
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Myocardial ischaemia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Palpitations
         subjects affected / exposed
    10 / 8687 (0.12%)
         occurrences all number
    11
    Pericardial effusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tachyarrhythmia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Tachycardia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Nervous system disorders
    Aphonia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Ataxia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Balance disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Burning sensation
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Cerebral ischaemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Cervical radiculopathy
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Cervicobrachial syndrome
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Cognitive disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Dementia alzheimer’s type
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    117 / 8687 (1.35%)
         occurrences all number
    126
    Dysgeusia
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Essential tremor
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Facial paralysis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Hand-arm vibration syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Head discomfort
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    678 / 8687 (7.80%)
         occurrences all number
    896
    Hyperaesthesia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Hypersomnia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Hypoaesthesia
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Intercostal neuralgia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Lethargy
         subjects affected / exposed
    27 / 8687 (0.31%)
         occurrences all number
    31
    Loss of consciousness
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Memory impairment
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Mental impairment
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    3
    Migraine
         subjects affected / exposed
    15 / 8687 (0.17%)
         occurrences all number
    18
    Morton’s neuralgia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Muscle contractions involuntary
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Myasthenia gravis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Neuralgia
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Paraesthesia
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Poor quality sleep
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    6
    Presyncope
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Radiculopathy
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    15 / 8687 (0.17%)
         occurrences all number
    15
    Sensory disturbance
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Sinus headache
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Somnolence
         subjects affected / exposed
    22 / 8687 (0.25%)
         occurrences all number
    22
    Syncope
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Taste disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tension headache
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Transient ischaemic attack
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Tremor
         subjects affected / exposed
    13 / 8687 (0.15%)
         occurrences all number
    13
    Trigeminal neuralgia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Vertebral artery occlusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Increased tendency to bruise
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Lymph node pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Lymphadenopathy
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    4
    Pseudolymphoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Deafness
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Ear pain
         subjects affected / exposed
    12 / 8687 (0.14%)
         occurrences all number
    12
    Ear pruritus
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Excessive cerumen production
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Hypoacusis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Meniere’s disease
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Motion sickness
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tinnitus
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    6
    Vertigo
         subjects affected / exposed
    18 / 8687 (0.21%)
         occurrences all number
    20
    Vertigo positional
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Eye disorders
    Accommodation disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Age-related macular degeneration
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Angle closure glaucoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Asthenopia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blepharitis
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Blepharospasm
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Blindness transient
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Cataract
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Conjunctivitis allergic
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Dry eye
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Eye haematoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Eye haemorrhage
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Eye inflammation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Eye irritation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Eye pain
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences all number
    9
    Eye swelling
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Glaucoma
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Iridocyclitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Lacrimation decreased
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Lacrimation increased
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    3
    Ocular discomfort
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Panophthalmitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Photophobia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Retinal disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Retinal drusen
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Retinal haemorrhage
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Retinal vein occlusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Swelling of eyelid
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Ulcerative keratitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    10 / 8687 (0.12%)
         occurrences all number
    11
    Abdominal distension
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    14 / 8687 (0.16%)
         occurrences all number
    15
    Abdominal pain lower
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    39 / 8687 (0.45%)
         occurrences all number
    45
    Anal inflammation
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Angular cheilitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Cheilitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Colitis
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    26 / 8687 (0.30%)
         occurrences all number
    26
    Crohn’s disease
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Dental caries
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    107 / 8687 (1.23%)
         occurrences all number
    114
    Diverticulum
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences all number
    9
    Dyspepsia
         subjects affected / exposed
    19 / 8687 (0.22%)
         occurrences all number
    20
    Dysphagia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Enteritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Epigastric discomfort
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Eructation
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Faeces soft
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Flatulence
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Food poisoning
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Gastric disorder
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Gastric ulcer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences all number
    9
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Gastritis erosive
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Gastrointestinal pain
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    4
    Gingival bleeding
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    12 / 8687 (0.14%)
         occurrences all number
    12
    Gingival ulceration
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Glossodynia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Haematochezia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Haemorrhoids
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Large intestine polyp
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Lip pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Lip swelling
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Lip ulceration
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Mouth swelling
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    164 / 8687 (1.89%)
         occurrences all number
    184
    Odynophagia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Oesophagitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Oral discomfort
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    2
    Oral mucosal blistering
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Oral pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Pancreatitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Paraesthesia oral
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    3
    Peptic ulcer
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Periodontal disease
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Proctitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Rectal tenesmus
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Reflux gastritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Retching
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Salivary gland calculus
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Stomatitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tongue blistering
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tongue dry
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tongue ulceration
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tooth disorder
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    14 / 8687 (0.16%)
         occurrences all number
    14
    Vomiting
         subjects affected / exposed
    37 / 8687 (0.43%)
         occurrences all number
    38
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Cholelithiasis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Hepatic function abnormal
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Hepatic steatosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Actinic keratosis
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Blister
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences all number
    8
    Cold sweat
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Decubitus ulcer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Dermal cyst
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Dermatitis
         subjects affected / exposed
    16 / 8687 (0.18%)
         occurrences all number
    16
    Dermatitis allergic
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Dermatitis atopic
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Dermatitis contact
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Dry skin
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Ecchymosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Eczema
         subjects affected / exposed
    26 / 8687 (0.30%)
         occurrences all number
    27
    Eczema asteatotic
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    29 / 8687 (0.33%)
         occurrences all number
    30
    Generalised erythema
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Haemorrhage subcutaneous
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    22 / 8687 (0.25%)
         occurrences all number
    23
    Hyperkeratosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Intertrigo
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Macule
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Night sweats
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Papule
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    57 / 8687 (0.66%)
         occurrences all number
    62
    Pruritus generalised
         subjects affected / exposed
    11 / 8687 (0.13%)
         occurrences all number
    11
    Psoriasis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Purpura
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    49 / 8687 (0.56%)
         occurrences all number
    51
    Rash erythematous
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Rash generalised
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Rash macular
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Rash maculovesicular
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Rash papular
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Rash pruritic
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Rosacea
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Seborrhoeic dermatitis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Sensitive skin
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Skin fissures
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Skin lesion
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Skin odour abnormal
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    3
    Urticaria
         subjects affected / exposed
    9 / 8687 (0.10%)
         occurrences all number
    11
    Urticaria contact
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Vasculitic ulcer
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Bladder prolapse
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Calculus urinary
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Chromaturia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Chronic kidney disease
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Dysuria
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Ketonuria
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Nephroangiosclerosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Nephrolithiasis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Nocturia
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Pollakiuria
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Polyuria
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Renal failure
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Renal impairment
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Renal pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Urethral polyp
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Urethral stenosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Urinary incontinence
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Endocrine disorders
    Hyperparathyroidism secondary
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Hypothyroidism
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    212 / 8687 (2.44%)
         occurrences all number
    237
    Arthritis
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Arthritis reactive
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Arthropathy
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    100 / 8687 (1.15%)
         occurrences all number
    106
    Bone decalcification
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Bone pain
         subjects affected / exposed
    13 / 8687 (0.15%)
         occurrences all number
    14
    Bursitis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Coccydynia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Costochondritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Exostosis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Fibromyalgia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Foot deformity
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Gouty arthritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Groin pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Growing pains
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Intervertebral disc space narrowing
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Joint range of motion decreased
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    3
    Joint stiffness
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Joint swelling
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences all number
    8
    Limb discomfort
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    5
    Muscle contracture
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Muscle fatigue
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Muscle spasms
         subjects affected / exposed
    24 / 8687 (0.28%)
         occurrences all number
    30
    Muscle tightness
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Muscle twitching
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Muscular weakness
         subjects affected / exposed
    11 / 8687 (0.13%)
         occurrences all number
    12
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    53 / 8687 (0.61%)
         occurrences all number
    55
    Musculoskeletal stiffness
         subjects affected / exposed
    17 / 8687 (0.20%)
         occurrences all number
    18
    Myalgia
         subjects affected / exposed
    386 / 8687 (4.44%)
         occurrences all number
    481
    Myalgia intercostal
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Myosclerosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Myositis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Neck pain
         subjects affected / exposed
    42 / 8687 (0.48%)
         occurrences all number
    43
    Nuchal rigidity
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Osteitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Osteoarthritis
         subjects affected / exposed
    27 / 8687 (0.31%)
         occurrences all number
    30
    Osteopenia
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Osteoporosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    103 / 8687 (1.19%)
         occurrences all number
    115
    Pain in jaw
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Patellofemoral pain syndrome
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Periarthritis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Plantar fasciitis
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Polymyalgia rheumatica
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Rotator cuff syndrome
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Scoliosis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Senile osteoporosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Spinal osteoarthritis
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Spinal pain
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Spondyloarthropathy
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Synovial cyst
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Temporomandibular joint syndrome
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Tendon pain
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Tendonitis
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Tenosynovitis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Torticollis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    3
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Acarodermatitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Acute sinusitis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Blastocystis infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Borrelia infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Bronchiolitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    40 / 8687 (0.46%)
         occurrences all number
    41
    Cellulitis
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences all number
    8
    Chronic sinusitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    18 / 8687 (0.21%)
         occurrences all number
    18
    Cystitis
         subjects affected / exposed
    17 / 8687 (0.20%)
         occurrences all number
    17
    Dacryocystitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Dengue fever
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Dermatophytosis of nail
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Diverticulitis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Ear infection
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Erysipelas
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Eye infection
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Folliculitis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Fungal infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Fungal skin infection
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Furuncle
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Gastric infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    17 / 8687 (0.20%)
         occurrences all number
    17
    Gastroenteritis viral
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Genital herpes
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Gingivitis
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Helicobacter infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Herpes simplex
         subjects affected / exposed
    19 / 8687 (0.22%)
         occurrences all number
    22
    Hordeolum
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Impetigo
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    52 / 8687 (0.60%)
         occurrences all number
    54
    Injection site cellulitis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Injection site infection
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Labyrinthitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Localised infection
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Lower respiratory tract infection
         subjects affected / exposed
    21 / 8687 (0.24%)
         occurrences all number
    21
    Lyme disease
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    228 / 8687 (2.62%)
         occurrences all number
    239
    Onychomycosis
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Oral candidiasis
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Oral fungal infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    31 / 8687 (0.36%)
         occurrences all number
    34
    Oral infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Otitis externa
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Otitis media
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Pathogen resistance
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Periodontitis
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Pertussis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    16 / 8687 (0.18%)
         occurrences all number
    16
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Pulpitis dental
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Pyelonephritis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    13 / 8687 (0.15%)
         occurrences all number
    13
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    18 / 8687 (0.21%)
         occurrences all number
    18
    Sinusitis
         subjects affected / exposed
    25 / 8687 (0.29%)
         occurrences all number
    26
    Skin candida
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Skin infection
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Subcutaneous abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Syphilis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Testicular abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tinea infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tinea pedis
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    7
    Tongue fungal infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    5 / 8687 (0.06%)
         occurrences all number
    5
    Tooth abscess
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Tooth infection
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Tracheitis
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    4
    Tracheobronchitis
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    80 / 8687 (0.92%)
         occurrences all number
    86
    Urinary tract infection
         subjects affected / exposed
    63 / 8687 (0.73%)
         occurrences all number
    66
    Vaginal infection
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Vaginitis gardnerella
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    6 / 8687 (0.07%)
         occurrences all number
    6
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Zika virus infection
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    15 / 8687 (0.17%)
         occurrences all number
    15
    Dehydration
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2
    Dyslipidaemia
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Gout
         subjects affected / exposed
    12 / 8687 (0.14%)
         occurrences all number
    12
    Hypercholesterolaemia
         subjects affected / exposed
    8 / 8687 (0.09%)
         occurrences all number
    8
    Hyperglycaemia
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Hyperlipidaemia
         subjects affected / exposed
    4 / 8687 (0.05%)
         occurrences all number
    4
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Hyperuricaemia
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    3
    Hypoglycaemia
         subjects affected / exposed
    3 / 8687 (0.03%)
         occurrences all number
    4
    Hypovitaminosis
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    7 / 8687 (0.08%)
         occurrences all number
    7
    Vitamin b12 deficiency
         subjects affected / exposed
    1 / 8687 (0.01%)
         occurrences all number
    1
    Vitamin d deficiency
         subjects affected / exposed
    2 / 8687 (0.02%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2015
    • Occurrence of suspected Herpes Zoster (HZ) episodes during the entire study period were evaluated as secondary objective. Therefore, wording related to collection, reporting and recording of HZ was added where applicable throughout the protocol. • Other minor changes have been made to correct typos and improve clarity and alignment within the document.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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