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    Clinical Trial Results:
    A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2013-003050-25
    Trial protocol
    		 SE   BE   IT   NL   ES   HU   CZ   GB   FR  
    Global end of trial date
    23 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Mar 2018
    First version publication date
    11 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    28431754DIA4003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01989754
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to assess the effect of canagliflozin compared to placebo on progression of albuminuria in subjects with Type 2 diabetes mellitus (T2DM) receiving standard care, but had inadequate glycemic control and were at elevated risk of cardiovascular (CV) events. Furthermore, study DIA4003 together with study DIA3008, constitutes the CANVAS program. An integrated analysis of CANVAS for cardiovascular safety was to use all subjects in DIA4003 and DIA3008 to show that a canagliflozin-associated risk in the CV risk ratio (if any), was significantly less than 1.3 using the two-sided 95% confidence interval of the risk ratio.
    Protection of trial subjects
    Several monitoring and adjudication committees were commissioned for this study, including an Academic Research Organization (ARO) which provided scientific and academic oversight and site monitoring for some sites; a Steering Committee of external scientific experts; an Independent Data Monitoring Committee (IDMC); an independent Endpoint Adjudication Committee (EAC), which reviewed blinded data for selected specific events; separate adjudication committees, which were employed to review cases of diabetic ketoacidosis (DKA), fracture, renal events, and pancreatitis; and a company internal Medical Safety Review Committee (MSRC).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jan 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 305
    Country: Number of subjects enrolled
    Australia: 109
    Country: Number of subjects enrolled
    Belgium: 152
    Country: Number of subjects enrolled
    Brazil: 549
    Country: Number of subjects enrolled
    Canada: 282
    Country: Number of subjects enrolled
    China: 92
    Country: Number of subjects enrolled
    Czech Republic: 139
    Country: Number of subjects enrolled
    Germany: 101
    Country: Number of subjects enrolled
    Spain: 496
    Country: Number of subjects enrolled
    France: 124
    Country: Number of subjects enrolled
    United Kingdom: 151
    Country: Number of subjects enrolled
    Hungary: 179
    Country: Number of subjects enrolled
    Italy: 98
    Country: Number of subjects enrolled
    Korea, Republic of: 167
    Country: Number of subjects enrolled
    Mexico: 228
    Country: Number of subjects enrolled
    Malaysia: 92
    Country: Number of subjects enrolled
    Netherlands: 249
    Country: Number of subjects enrolled
    New Zealand: 105
    Country: Number of subjects enrolled
    Poland: 363
    Country: Number of subjects enrolled
    Russian Federation: 412
    Country: Number of subjects enrolled
    Sweden: 221
    Country: Number of subjects enrolled
    Taiwan: 76
    Country: Number of subjects enrolled
    Ukraine: 449
    Country: Number of subjects enrolled
    United States: 673
    Worldwide total number of subjects
    5812
    EEA total number of subjects
    2273
    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)
    2976
    From 65 to 84 years
    2810
    85 years and over
    26

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 5,813 subjects were randomized; however, 1 subject was randomized twice and only the first randomization was included in the Intent-to-treat (ITT) analysis set. Thus 2,905 and 2,907 subjects were randomly assigned to the placebo and canagliflozin groups in the ITT analysis set, respectively.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one capsule of placebo orally once daily for the duration of the study or until early discontinuation from treatment.

    Arm title
    		 Canagliflozin
    Arm description
    		 Subjects received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the subject required additional glycemic control, provided the 100-mg dose was well tolerated).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canagliflozin 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received canagliflozin (JNJ-28431754) 100 mg once daily during the first 13 weeks.

    Investigational medicinal product name
    Canagliflozin 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received canagliflozin (JNJ-28431754) 300 mg once daily after the first 13 weeks.

    Number of subjects in period 1
    		Placebo Canagliflozin
    Started
    2905
    2907
    Completed
    2866
    2872
    Not completed
    39
    35
         Consent withdrawn by subject
    10
    14
         Other - closed site
    1
    1
         Lost to follow-up
    28
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group title
    Canagliflozin
    Reporting group description
    		 Subjects received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the subject required additional glycemic control, provided the 100-mg dose was well tolerated).

    Reporting group values
    		 Placebo Canagliflozin Total
    Number of subjects
    		 2905 2907 5812
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 1479 1497 2976
        From 65 to 84 years
    		 1413 1397 2810
        85 years and over
    		 13 13 26
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 64 ( 8.28 ) 63.9 ( 8.42 ) -
    Title for Gender
    Units: subjects
        Female
    		 1111 1053 2164
        Male
    		 1794 1854 3648

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group title
    Canagliflozin
    Reporting group description
    		 Subjects received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the subject required additional glycemic control, provided the 100-mg dose was well tolerated).

    Primary: Time to the First Occurrence of Progression of Albuminuria

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    End point title
    		 Time to the First Occurrence of Progression of Albuminuria
    End point description
    Event rate was estimated based on the time to the first occurrence of the event. Progression defined as the development of micro-albuminuria (UACR 30 to 300 milligram per gram [mg/g]) or macroalbuminuria (Albumin/creatinine ratio [ACR] of > 300 mg/g) in a subject with baseline normoalbuminuria (ACR less than [<] 30 mg/g) or the development of macro-albuminuria in a subject with baseline microalbuminuria with an ACR increase greater than or equal to (>=) 30 percent from baseline. The intent to treat (ITT) population included all the randomized subjects. Here 'N' signifies number of subjects who were evaluable for this endpoint. Subjects with macroalbuminuria at baseline (ACR>300 mg/g) are excluded from the analysis.
    End point type
    Primary
    End point timeframe
    Up to 3 years
    End point values
    		 Placebo Canagliflozin
    Number of subjects analysed
    2518
    2541
    Units: Events per 1000 patient-year
        number (not applicable)
    153.01
    99.80
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin
    Number of subjects included in analysis
    5059
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cox proportional hazard method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.73

    Secondary: Time to the First Occurrence of Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure

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    End point title
    		 Time to the First Occurrence of Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure
    End point description
    Event rate was estimated based on the time to the first occurrence of the event. Analyses were using adjudicated events, i.e. CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. The ITT Analysis Set included the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Approximately 3 years
    End point values
    		 Placebo Canagliflozin
    Number of subjects analysed
    2905
    2907
    Units: Events per 1000 patient-years
        number (not applicable)
    21.91
    15.85
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin
    Number of subjects included in analysis
    5812
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0148
    Method
    		 Stratified Cox proportional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 0.94

    Secondary: Time to the First Occurrence of CV Death

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    End point title
    		 Time to the First Occurrence of CV Death
    End point description
    Event rate was estimated based on the time to the first occurrence of the event. Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. The ITT Analysis Set included the randomized subjects.
    End point type
    Secondary
    End point timeframe
    Approximately 3 years
    End point values
    		 Placebo Canagliflozin
    Number of subjects analysed
    2905
    2907
    Units: Events per 1000 patient-years
        number (not applicable)
    11.60
    10.06
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin
    Number of subjects included in analysis
    5812
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4067
    Method
    		 Stratified Cox proportional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.22

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 3 years
    Adverse event reporting additional description
    On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received one capsule of placebo orally once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group title
    Canagliflozin
    Reporting group description
    		 Subjects received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the subject required additional glycemic control, provided the 100-mg dose was well tolerated).

    Serious adverse events
    		 Placebo Canagliflozin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    775 / 2903 (26.70%)
    714 / 2904 (24.59%)
         number of deaths (all causes)
    71
    68
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Myeloid Leukaemia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma Gastric
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of Colon
         subjects affected / exposed
    3 / 2903 (0.10%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenosquamous Cell Lung Cancer
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-Cell Lymphoma
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Lung Neoplasm
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Neoplasm
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Neoplasm of Thyroid Gland
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Cancer
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder Cancer
         subjects affected / exposed
    4 / 2903 (0.14%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer Recurrent
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's Disease
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Adenoma
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    2 / 2903 (0.07%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast Cancer Metastatic
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast Cancer Stage Ii
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer Stage Iii
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Hygroma
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Chronic Myeloid Leukaemia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Adenoma
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    0 / 2903 (0.00%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colon Cancer Metastatic
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colorectal Adenocarcinoma
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal Cancer
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Glioblastoma
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hodgkin's Disease
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Cell Lung Cancer
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal Cancer
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    2 / 2903 (0.07%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Lung Adenocarcinoma Metastatic
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung Cancer Metastatic
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    6 / 2903 (0.21%)
    6 / 2904 (0.21%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    0 / 2903 (0.00%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma in Situ
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Neoplasm of Unknown Primary Site
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinum Neoplasm
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Meningioma Benign
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to Central Nervous System
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to Liver
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neuroendocrine Carcinoma Metastatic
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Neuroendocrine Tumour
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's Lymphoma
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Small Cell Lung Cancer
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian Cancer Metastatic
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic Carcinoma
         subjects affected / exposed
    6 / 2903 (0.21%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Papillary Cystadenoma Lymphomatosum
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary Thyroid Cancer
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma Cell Myeloma
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    8 / 2903 (0.28%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer Metastatic
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer
         subjects affected / exposed
    3 / 2903 (0.10%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cancer
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schwannoma
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Serous Cystadenocarcinoma of Pancreas
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Cell Lung Cancer Metastatic
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of Lung
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of Skin
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of the Oral Cavity
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of the Tongue
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue Neoplasm Malignant Stage Unspecified
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric Cancer
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Cancer
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Leiomyoma
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic Aneurysm
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Arteriosclerosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Stenosis
         subjects affected / exposed
    4 / 2903 (0.14%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Thrombosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Circulatory Collapse
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic Vascular Disorder
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity Necrosis
         subjects affected / exposed
    5 / 2903 (0.17%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    4 / 2903 (0.14%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    6 / 2903 (0.21%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    3 / 2903 (0.10%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic Shock
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Iliac Artery Occlusion
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent Claudication
         subjects affected / exposed
    3 / 2903 (0.10%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    4 / 2903 (0.14%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    9 / 2903 (0.31%)
    9 / 2904 (0.31%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Occlusion
         subjects affected / exposed
    1 / 2903 (0.03%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Stenosis
         subjects affected / exposed
    2 / 2903 (0.07%)
    8 / 2904 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Thrombosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Embolism
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    5 / 2903 (0.17%)
    7 / 2904 (0.24%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    4 / 2903 (0.14%)
    9 / 2904 (0.31%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Venous Disease
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poor Peripheral Circulation
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post Thrombotic Syndrome
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Insufficiency
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Surgical and medical procedures
    Coronary Arterial Stent Insertion
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospitalisation
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent Placement
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse Drug Reaction
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Death
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chest Discomfort
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    17 / 2903 (0.59%)
    22 / 2904 (0.76%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Complication Associated with Device
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    7 / 2903 (0.24%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 5
         deaths causally related to treatment / all
    1 / 7
    0 / 5
    Drug Intolerance
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait Disturbance
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised Oedema
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired Healing
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    7 / 2903 (0.24%)
    9 / 2904 (0.31%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Swelling
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 2903 (0.10%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Cardiac Death
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sudden Death
         subjects affected / exposed
    6 / 2903 (0.21%)
    6 / 2904 (0.21%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 6
         deaths causally related to treatment / all
    0 / 6
    1 / 6
    Vascular Stent Restenosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Stent Thrombosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Penile Prosthesis User
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Victim of Homicide
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    5 / 2903 (0.17%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Hyperplasia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Hypertrophy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymal Disorder
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile Dysfunction
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fallopian Tube Cyst
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peyronie's Disease
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    3 / 2903 (0.10%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Polyp
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Prolapse
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    5 / 2903 (0.17%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    3 / 2903 (0.10%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 2903 (0.07%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic Crisis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Chronic
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    11 / 2903 (0.38%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    8 / 2903 (0.28%)
    8 / 2904 (0.28%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 2903 (0.00%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemoptysis
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoventilation
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal Effusion
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Obstruction
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    5 / 2903 (0.17%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    5 / 2903 (0.17%)
    6 / 2904 (0.21%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pulmonary Fibrosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary Mass
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    6 / 2903 (0.21%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pulmonary Sarcoidosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Acidosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Alkalosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    3 / 2903 (0.10%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Sleep Apnoea Syndrome
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal Cord Leukoplakia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar Disorder
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed Suicide
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Confusional State
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression Suicidal
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emotional Disorder
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device Breakage
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Loosening
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Malfunction
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patient-Device Incompatibility
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Colic
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis Acute
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    3 / 2903 (0.10%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    7 / 2903 (0.24%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis Obstructive
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Polyp
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemobilia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cirrhosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Lesion
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocholecystis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice Cholestatic
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Injury
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Alcoholic Steatohepatitis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Arteriogram Coronary
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Glucose Increased
         subjects affected / exposed
    3 / 2903 (0.10%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection Fraction Decreased
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram St-T Change
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram T Wave Inversion
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International Normalised Ratio Increased
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Function Test Increased
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet Count Decreased
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle Fracture
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Bypass Stenosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Restenosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract Operation Complication
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle Fracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    3 / 2903 (0.10%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Epiphyseal Fracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Injury
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Bones Fracture
         subjects affected / exposed
    1 / 2903 (0.03%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    4 / 2903 (0.14%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femur Fracture
         subjects affected / exposed
    6 / 2903 (0.21%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured Coccyx
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand Fracture
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    5 / 2903 (0.17%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    2 / 2903 (0.07%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw Fracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Sprain
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Crushing Injury
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    2 / 2903 (0.07%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocephalus
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Laminectomy Syndrome
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haematoma
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haematuria
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Hernia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Respiratory Failure
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Headache
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis Fracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    4 / 2903 (0.14%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Spinal Fracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid Haemorrhage
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suture Related Complication
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Injury
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    1 / 2903 (0.03%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to Various Agents
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Traumatic Fracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Ulcer
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna Fracture
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Graft Stenosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Dehiscence
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Necrosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    11 / 2903 (0.38%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Left Ventricular Failure
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    26 / 2903 (0.90%)
    32 / 2904 (1.10%)
         occurrences causally related to treatment / all
    0 / 31
    1 / 35
         deaths causally related to treatment / all
    0 / 3
    0 / 6
    Adams-Stokes Syndrome
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    33 / 2903 (1.14%)
    22 / 2904 (0.76%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    42 / 2903 (1.45%)
    42 / 2904 (1.45%)
         occurrences causally related to treatment / all
    0 / 54
    0 / 47
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Disease
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Incompetence
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    5 / 2903 (0.17%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    18 / 2903 (0.62%)
    14 / 2904 (0.48%)
         occurrences causally related to treatment / all
    1 / 22
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    7 / 2903 (0.24%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Tachycardia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    1 / 2903 (0.03%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    9 / 2903 (0.31%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 8
    0 / 3
    Cardiac Disorder
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    41 / 2903 (1.41%)
    19 / 2904 (0.65%)
         occurrences causally related to treatment / all
    0 / 47
    2 / 21
         deaths causally related to treatment / all
    0 / 5
    0 / 1
    Cardiac Failure Acute
         subjects affected / exposed
    3 / 2903 (0.10%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Chronic
         subjects affected / exposed
    3 / 2903 (0.10%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac Failure Congestive
         subjects affected / exposed
    18 / 2903 (0.62%)
    11 / 2904 (0.38%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac Valve Disease
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiogenic Shock
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiopulmonary Failure
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conduction Disorder
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive Cardiomyopathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    29 / 2903 (1.00%)
    34 / 2904 (1.17%)
         occurrences causally related to treatment / all
    1 / 30
    0 / 36
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Coronary Artery Insufficiency
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Occlusion
         subjects affected / exposed
    3 / 2903 (0.10%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    8 / 2903 (0.28%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Cardiomyopathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    4 / 2903 (0.14%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left Ventricular Dysfunction
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left Ventricular Failure
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mitral Valve Stenosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Fibrosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial Infarction
         subjects affected / exposed
    24 / 2903 (0.83%)
    31 / 2904 (1.07%)
         occurrences causally related to treatment / all
    1 / 24
    1 / 34
         deaths causally related to treatment / all
    0 / 1
    0 / 8
    Myocardial Ischaemia
         subjects affected / exposed
    9 / 2903 (0.31%)
    7 / 2904 (0.24%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    3 / 2903 (0.10%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal Angina
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right Ventricular Failure
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Bradycardia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Node Dysfunction
         subjects affected / exposed
    4 / 2903 (0.14%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid Valve Incompetence
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Arrhythmia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Asystole
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ventricular Extrasystoles
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Basilar Artery Occlusion
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Injury
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Stem Infarction
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Stem Stroke
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Arteriosclerosis
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Occlusion
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    7 / 2903 (0.24%)
    9 / 2904 (0.31%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal Tunnel Syndrome
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar Infarction
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Haematoma
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Haemorrhage
         subjects affected / exposed
    1 / 2903 (0.03%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral Infarction
         subjects affected / exposed
    5 / 2903 (0.17%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Ischaemia
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    37 / 2903 (1.27%)
    15 / 2904 (0.52%)
         occurrences causally related to treatment / all
    2 / 41
    0 / 17
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Cervicobrachial Syndrome
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive Disorder
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Mononeuropathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness Postural
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic Stroke
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Nerve Disorder
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised Tonic-Clonic Seizure
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Stroke
         subjects affected / exposed
    4 / 2903 (0.14%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Headache
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Encephalopathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-Ischaemic Encephalopathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraventricular Haemorrhage
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Cerebral Infarction
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    12 / 2903 (0.41%)
    20 / 2904 (0.69%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 21
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Lacunar Infarction
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar Stroke
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of Consciousness
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Radiculopathy
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Encephalopathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia Gravis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia Gravis Crisis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve Compression
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Nerve Paresis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 2903 (0.03%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory Loss
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    8 / 2903 (0.28%)
    10 / 2904 (0.34%)
         occurrences causally related to treatment / all
    0 / 8
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic Infarction
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic Encephalopathy
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    10 / 2903 (0.34%)
    8 / 2904 (0.28%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal Neuralgia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Encephalopathy
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Headache
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral Artery Occlusion
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar Insufficiency
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal Cord Paralysis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 2903 (0.21%)
    10 / 2904 (0.34%)
         occurrences causally related to treatment / all
    0 / 8
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Haematotympanum
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis Fugax
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    3 / 2903 (0.10%)
    10 / 2904 (0.34%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Retinopathy
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Haemorrhage
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Pain
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid Ptosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular Fibrosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Artery Occlusion
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Hernia
         subjects affected / exposed
    3 / 2903 (0.10%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    5 / 2903 (0.17%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's Oesophagus
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowel Movement Irregularity
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Microscopic
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ulcerative
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic Pseudo-Obstruction
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 2903 (0.14%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular Perforation
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Intestinal
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Perforation
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Poisoning
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Polyps
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    3 / 2903 (0.10%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired Gastric Emptying
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    4 / 2903 (0.14%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Haemorrhage
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Ischaemia
         subjects affected / exposed
    3 / 2903 (0.10%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Ulcer Perforation
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric Arterial Occlusion
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric Vein Thrombosis
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal Obstruction
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    2 / 2903 (0.07%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Tenesmus
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary Gland Calculus
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Salivary Gland Fistula
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swollen Tongue
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Disorder
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    1 / 2903 (0.03%)
    6 / 2904 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    2 / 2903 (0.07%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Allergic
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot
         subjects affected / exposed
    9 / 2903 (0.31%)
    10 / 2904 (0.34%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ulcer
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Fissures
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Necrosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    5 / 2903 (0.17%)
    7 / 2904 (0.24%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    15 / 2903 (0.52%)
    7 / 2904 (0.24%)
         occurrences causally related to treatment / all
    2 / 17
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Bladder Obstruction
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Kidney Disease
         subjects affected / exposed
    2 / 2903 (0.07%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic Nephropathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 2903 (0.03%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketonuria
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 2903 (0.07%)
    8 / 2904 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy Toxic
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic Syndrome
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvi-Ureteric Obstruction
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pollakiuria
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Haematoma
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal Injury
         subjects affected / exposed
    3 / 2903 (0.10%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress Urinary Incontinence
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial Nephritis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Stenosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Incontinence
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Basedow's Disease
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism Primary
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 2903 (0.10%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    11 / 2903 (0.38%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Spinal Stenosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dactylitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's Contracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity Contracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Deformity
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Compression
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Disorder
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    5 / 2903 (0.17%)
    7 / 2904 (0.24%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee Deformity
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    4 / 2903 (0.14%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    16 / 2903 (0.55%)
    13 / 2904 (0.45%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plantar Fasciitis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia Rheumatica
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    1 / 2903 (0.03%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacroiliitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    4 / 2903 (0.14%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Pain
         subjects affected / exposed
    3 / 2903 (0.10%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial Cyst
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis Stenosans
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger Finger
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Neck
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 2903 (0.07%)
    6 / 2904 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 2903 (0.10%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter Gastroenteritis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    11 / 2903 (0.38%)
    9 / 2904 (0.31%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis Staphylococcal
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis Streptococcal
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Infective
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic Abscess
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Related Infection
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot Infection
         subjects affected / exposed
    4 / 2903 (0.14%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Gangrene
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    3 / 2903 (0.10%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear Infection
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    5 / 2903 (0.17%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Escherichia Infection
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Sepsis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Infection
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    2 / 2903 (0.07%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    9 / 2903 (0.31%)
    8 / 2904 (0.28%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 2903 (0.03%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital Infection Fungal
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis B
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiv Infection
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Dermal Cyst
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    1 / 2903 (0.03%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Exacerbation of Chronic Obstructive Airways Disease
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 2903 (0.03%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Discitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    6 / 2903 (0.21%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    6 / 2903 (0.21%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Abscess
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    5 / 2903 (0.17%)
    6 / 2904 (0.21%)
         occurrences causally related to treatment / all
    0 / 6
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Chronic
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media Acute
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parasitic Gastroenteritis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Abscess
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile Abscess
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perinephric Abscess
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar Abscess
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal Sepsis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    31 / 2903 (1.07%)
    26 / 2904 (0.90%)
         occurrences causally related to treatment / all
    1 / 33
    0 / 27
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    Pneumonia Legionella
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Pneumococcal
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Infection
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Sepsis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Sepsis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 2903 (0.07%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    3 / 2903 (0.10%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    13 / 2903 (0.45%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Abscess
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Infection
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    9 / 2903 (0.31%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Septic Shock
         subjects affected / exposed
    6 / 2903 (0.21%)
    4 / 2904 (0.14%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Sinusitis
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Infection
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Sepsis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stenotrophomonas Infection
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous Abscess
         subjects affected / exposed
    2 / 2903 (0.07%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Abscess
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Infection
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 2903 (0.07%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    13 / 2903 (0.45%)
    11 / 2904 (0.38%)
         occurrences causally related to treatment / all
    6 / 13
    4 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection Enterococcal
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 2903 (0.07%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus
         subjects affected / exposed
    18 / 2903 (0.62%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    12 / 2903 (0.41%)
    6 / 2904 (0.21%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Complication
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    2 / 2903 (0.07%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte Imbalance
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Overload
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    11 / 2903 (0.38%)
    5 / 2904 (0.17%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    5 / 2903 (0.17%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperosmolar Hyperglycaemic State
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 2903 (0.00%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    9 / 2903 (0.31%)
    6 / 2904 (0.21%)
         occurrences causally related to treatment / all
    2 / 10
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 2903 (0.03%)
    0 / 2904 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    4 / 2903 (0.14%)
    3 / 2904 (0.10%)
         occurrences causally related to treatment / all
    3 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    2 / 2903 (0.07%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic Acidosis
         subjects affected / exposed
    0 / 2903 (0.00%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Metabolic Acidosis
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    3 / 2903 (0.10%)
    2 / 2904 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    1 / 2903 (0.03%)
    1 / 2904 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Canagliflozin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 2903 (0.86%)
    94 / 2904 (3.24%)
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    25 / 2903 (0.86%)
    94 / 2904 (3.24%)
         occurrences all number
    29
    125

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2015
    The primary reason was to incorporate a request by Health Authorities to include diabetic ketoacidosis (DKA) safety information and handling of subjects surrounding this event.
    05 May 2016
    The primary reason to amend the study protocol was to include new safety information and guidance regarding subject management surrounding the event of lower extremity amputations.
    01 Sep 2016
    The primary reason to amend the study protocol was to add secondary cardiovascular objectives and exploratory renal objectives.

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

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

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