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    Clinical Trial Results:
    Efficacy, Immunogenicity, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection

    Summary
    EudraCT number
    		 2013-000775-32
    Trial protocol
    		 FI   SE   GB   DE   ES   DK   PL   CZ   RO  
    Global end of trial date
    12 Jun 2018

    Results information
    Results version number
    		 v1
    This version publication date
    27 Jun 2019
    First version publication date
    27 Jun 2019
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    H-030-014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01887912
    WHO universal trial number (UTN)
    		 U1111-1127-7162
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, PA, United States, 18370
    Public contact
    Sanofi Pasteur, Trial Transparency Team, Contact-US@sanofi.com
    Scientific contact
    Sanofi Pasteur, Trial Transparency Team, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Jan 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary C. difficile infection (CDI) confirmed by polymerase chain reaction (PCR) in adult subjects aged ≥50 years who are at risk for CDI and have received at least 1 injection
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 2013
    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
    Poland: 58
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Spain: 145
    Country: Number of subjects enrolled
    Sweden: 11
    Country: Number of subjects enrolled
    United Kingdom: 207
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Finland: 343
    Country: Number of subjects enrolled
    France: 210
    Country: Number of subjects enrolled
    Germany: 198
    Country: Number of subjects enrolled
    Australia: 170
    Country: Number of subjects enrolled
    Japan: 194
    Country: Number of subjects enrolled
    Korea, Republic of: 428
    Country: Number of subjects enrolled
    Philippines: 233
    Country: Number of subjects enrolled
    Singapore: 161
    Country: Number of subjects enrolled
    Taiwan: 127
    Country: Number of subjects enrolled
    Thailand: 24
    Country: Number of subjects enrolled
    Brazil: 1151
    Country: Number of subjects enrolled
    Chile: 7
    Country: Number of subjects enrolled
    Colombia: 974
    Country: Number of subjects enrolled
    Costa Rica: 11
    Country: Number of subjects enrolled
    Dominica: 54
    Country: Number of subjects enrolled
    Guatemala: 2
    Country: Number of subjects enrolled
    Mexico: 577
    Country: Number of subjects enrolled
    Panama: 39
    Country: Number of subjects enrolled
    Peru: 464
    Country: Number of subjects enrolled
    Canada: 327
    Country: Number of subjects enrolled
    Puerto Rico: 17
    Country: Number of subjects enrolled
    United States: 3159
    Worldwide total number of subjects
    9302
    EEA total number of subjects
    1183
    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)
    4414
    From 65 to 84 years
    4716
    85 years and over
    172

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled in the study from 30 July 2013 to 17 November 2017.

    Pre-assignment
    Screening details
    		 A total of 9302 subjects were enrolled and randomized in the study.

    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, Assessor
    Blinding implementation details
    This study was observer-blind. The vaccine preparer and administrator may have been unblinded to treatment assignment due to the steps necessary for vaccine preparation. However, the subject, the Investigator, and study staff members who collected the safety data and laboratory personnel who analysed the blood and stool samples were all blinded to the group.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 C. Difficile Vaccine Group
    Arm description
    		 Subjects received 1 injection of 0.5 milliliter (mL) C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
    Arm type
    		 Experimental

    Investigational medicinal product name
    C. difficile Toxoid Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).

    Arm title
    		 Placebo Group
    Arm description
    		 Subjects received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).

    Number of subjects in period 1
    		C. Difficile Vaccine Group Placebo Group
    Started
    6201
    3101
    Safety Population
    6113
    3057
    Completed
    4809
    2370
    Not completed
    1392
    731
         Consent withdrawn by subject
    606
    349
         Adverse event
    34
    15
         Unspecified
    122
    58
         Serious adverse event
    400
    198
         Lost to follow-up
    163
    74
         Protocol deviation
    67
    37

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    C. Difficile Vaccine Group
    Reporting group description
    		 Subjects received 1 injection of 0.5 milliliter (mL) C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).

    Reporting group values
    		 C. Difficile Vaccine Group Placebo Group Total
    Number of subjects
    		 6201 3101 9302
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.9 ( 8.86 ) 65.8 ( 8.87 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2629 1294 3923
        Male
    		 3572 1807 5379
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 330 171 501
        Not Hispanic or Latino
    		 2780 1390 4170
        Unknown or Not Reported
    		 3091 1540 4631
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 6 6 12
        Asian
    		 795 398 1193
        Native Hawaiian or Other Pacific Islander
    		 5 4 9
        Black or African American
    		 206 102 308
        White
    		 2983 1487 4470
        More than one race
    		 8 5 13
        Unknown or Not Reported
    		 2198 1099 3297

    End points

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    End points reporting groups
    Reporting group title
    C. Difficile Vaccine Group
    Reporting group description
    		 Subjects received 1 injection of 0.5 milliliter (mL) C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).

    Primary: Number of Subjects With Symptomatic PCR-Confirmed Primary CDI Cases

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    End point title
    		 Number of Subjects With Symptomatic PCR-Confirmed Primary CDI Cases [1]
    End point description
    Symptomatic PCR-confirmed CDI cases were defined as the number of subjects with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on modified intent-to-treat (mITT) population which included all subjects who received at least 1 injection and were analyzed according to the group to which they were randomized.
    End point type
    Primary
    End point timeframe
    Up to 3 years post injection 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    6173
    3085
    Units: subjects
    34
    16
    No statistical analyses for this end point

    Secondary: Number of Subjects With Severe PCR-Confirmed Primary CDI Cases

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    End point title
    		 Number of Subjects With Severe PCR-Confirmed Primary CDI Cases
    End point description
    Severe CDI cases were defined as number of subjects with at least one of the following symptoms: fever >= 38.5 degree Celsius (°C), white blood cell count >= 15,000 cells/mm^3, ileus, pseudomembranous colitis, serum albumin <3 gram per deciliter, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis. Analysis was performed on subjects with protocol-defined (PCR confirmed) primary CDI cases.
    End point type
    Secondary
    End point timeframe
    Up to 3 years post injection 1
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    34
    16
    Units: subjects
    9
    6
    No statistical analyses for this end point

    Secondary: Number of Subjects With Loose Stool Episodes

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    End point title
    		 Number of Subjects With Loose Stool Episodes
    End point description
    Loose stools were defined as type 6 (fluffy pieces with ragged edges, mushy) or type 7 (watery, no solid pieces) according to the Bristol Stool Chart. In this endpoint, subject with number of loose stool episodes (categorized as: loose stool episodes less than 3, 3 to 6, 7 to 10, 11 to 15 and greater than 15) were reported. Analysis was performed on subjects with protocol-defined (PCR confirmed) primary CDI cases.
    End point type
    Secondary
    End point timeframe
    Up to 3 years post injection 1
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    34
    16
    Units: subjects
        <3
    0
    0
        3 to 6
    7
    4
        7 to 10
    7
    2
        11 to 15
    7
    4
        >15
    13
    6
    No statistical analyses for this end point

    Secondary: Number of Subjects With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population

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    End point title
    		 Number of Subjects With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population
    End point description
    Symptomatic PCR confirmed CDI cases were defined as the number of subjects with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on per-protocol efficacy analysis set (PPEAS) which included subjects who had at least 1 injection, no relevant protocol deviations (not meet inclusion criteria/ met exclusion criteria, not receive any vaccine/not received in proper time window, received different vaccine than randomized, preparation and / or administration of vaccine not done per protocol, received protocol-restricted therapy).
    End point type
    Secondary
    End point timeframe
    Up to 3 years post injection 1
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    4786
    2378
    Units: subjects
    23
    13
    No statistical analyses for this end point

    Secondary: Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-linked Immunosorbent Assay (ELISA)

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    End point title
    		 Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-linked Immunosorbent Assay (ELISA)
    End point description
    Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as geometric mean concentration (GMC). The 2-sided 95% Confidence Interval (CI) of GMC was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set, which included subjects who had at least 1 injection, no relevant protocol deviations (not met inclusion criteria/ met exclusion criteria, not received vaccine/ not received in proper time window, received different vaccine than randomized, preparation and/ or administration of vaccine not per protocol, protocol-restricted therapy, not provided post-dose serology sample/serology sample did not produced a valid test result). Here, ‘n’ = subejcts with available data for each specified category for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    471
    236
    Units: ELISA units per milliliter (EU/mL)
    geometric mean (confidence interval 95%)
        Toxin A ImunnoglobulinG (IgG): Day 0 (n=468, 230)
    0.957 (0.897 to 1.02)
    0.999 (0.912 to 1.09)
        Toxin A IgG: Day 14 (n=418, 214)
    3.19 (2.68 to 3.80)
    0.913 (0.849 to 0.983)
        Toxin A IgG: Day 30 (n=456, 230)
    12.2 (10.4 to 14.3)
    0.959 (0.889 to 1.03)
        Toxin A IgG: Day 60 (n=417, 212)
    43.7 (38.1 to 50.2)
    0.933 (0.867 to 1.00)
        Toxin A IgG: Day 210 (n=355, 182)
    12.0 (10.5 to 13.8)
    0.944 (0.865 to 1.03)
        Toxin A IgG: Day 390 (n=320, 159)
    6.02 (5.23 to 6.93)
    0.955 (0.856 to 1.06)
        Toxin A IgG: Day 570 (n=277, 145)
    4.50 (3.86 to 5.25)
    0.908 (0.834 to 0.989)
        Toxin A IgG: Day 750 (n=191, 93)
    4.02 (3.38 to 4.78)
    0.856 (0.776 to 0.944)
        Toxin A IgG: Day 930 (n=108, 66)
    3.83 (3.02 to 4.85)
    0.902 (0.796 to 1.02)
        Toxin A IgG: Day 1110 (n=59, 36)
    3.75 (2.64 to 5.34)
    1.09 (0.786 to 1.50)
        Toxin B IgG: Day 0 (n=468, 231)
    1.40 (1.24 to 1.57)
    1.49 (1.24 to 1.79)
        Toxin B IgG: Day 14 (n=419, 216)
    4.36 (3.37 to 5.64)
    1.56 (1.29 to 1.89)
        Toxin B IgG: Day 30 (n=455, 231)
    10.0 (7.85 to 12.8)
    1.46 (1.21 to 1.75)
        Toxin B IgG: Day 60 (n=417, 212)
    24.8 (20.1 to 30.6)
    1.42 (1.18 to 1.71)
        Toxin B IgG: Day 210 (n=354, 182)
    6.62 (5.36 to 8.19)
    1.31 (1.07 to 1.61)
        Toxin B IgG: Day 390 (n=319, 159)
    3.98 (3.15 to 5.02)
    1.24 (0.991 to 1.56)
        Toxin B IgG: Day 570 (n=277, 145)
    3.37 (2.63 to 4.32)
    1.15 (0.905 to 1.47)
        Toxin B IgG: Day 750 (n=191, 93)
    2.86 (2.14 to 3.84)
    1.11 (0.840 to 1.47)
        Toxin B IgG: Day 930 (n=108, 66)
    2.42 (1.65 to 3.55)
    1.13 (0.812 to 1.58)
        Toxin B IgG: Day 1110 (n=59, 36)
    3.46 (2.06 to 5.81)
    0.966 (0.592 to 1.58)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA

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    End point title
    		 Percentage of Subjects With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA
    End point description
    Percentage of subejcts with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by ELISA. The 2-sided 95% Cl of the percentage was based on Exact method calculations. Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, ‘number of subjects analysed’ = subjects evaluable for this outcome measure and ‘n’ = subjects with available data for each specified category for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 60
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    436
    220
    Units: percentage of subjects
    number (confidence interval 95%)
        Toxin A IgG: >=2 (n=433, 217)
    93.3 (90.5 to 95.5)
    0.9 (0.1 to 3.3)
        Toxin A IgG: >=4 (n=433, 217)
    88.9 (85.6 to 91.7)
    0.0 (0.0 to 1.7)
        Toxin B IgG: >=2 (n=433, 218)
    82.2 (78.3 to 85.7)
    4.6 (2.2 to 8.3)
        Toxin B IgG: >=4 (n=433, 218)
    73.2 (68.8 to 77.3)
    0.5 (0.0 to 2.5)
    No statistical analyses for this end point

    Secondary: Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Subjects With CDI

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    End point title
    		 Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Subjects With CDI
    End point description
    Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as GMC. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR-confirmed CDI cases were defined as the number of subjects with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on subjects with protocol-defined (PCR confirmed) primary CDI cases. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 and Day 60
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    34
    16
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Toxin A IgG: Day 0 (n=33, 16)
    1.15 (0.821 to 1.62)
    1.04 (0.661 to 1.64)
        Toxin A IgG: Day 60 (n=30, 16)
    42.1 (18.0 to 98.3)
    1.06 (0.632 to 1.76)
        Toxin B IgG: Day 0 (n=33, 16)
    1.41 (0.762 to 2.62)
    1.05 (0.504 to 2.20)
        Toxin B IgG: Day 60 (n=30, 16)
    19.3 (6.65 to 56.2)
    1.13 (0.609 to 2.11)
    No statistical analyses for this end point

    Secondary: Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)

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    End point title
    		 Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
    End point description
    Serum antibody concentrations against toxins A and B were measured by TNA and expressed as geometric mean titer (GMT). The 2-sided 95% Cl of GMT was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, ‘n’ = subjects with available data for each specified category for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    471
    236
    Units: Titer (1/dilution)
    geometric mean (confidence interval 95%)
        Toxin A TNA: Day 0 (n=466, 231)
    9.86 (9.22 to 10.5)
    10.1 (9.12 to 11.2)
        Toxin A TNA: Day 14 (n=419, 216)
    28.5 (22.7 to 35.8)
    9.86 (8.96 to 10.8)
        Toxin A TNA: Day 30 (n=456, 231)
    50.5 (40.9 to 62.3)
    9.97 (9.09 to 10.9)
        Toxin A TNA: Day 60 (n=416, 212)
    269 (226 to 322)
    9.82 (8.95 to 10.8)
        Toxin A TNA: Day 210 (n=354, 181)
    269 (228 to 317)
    10.3 (9.09 to 11.7)
        Toxin A TNA: Day 390 (n=320, 159)
    217 (183 to 259)
    10.1 (8.86 to 11.5)
        Toxin A TNA: Day 570 (n=277, 145)
    184 (153 to 223)
    9.86 (8.76 to 11.1)
        Toxin A TNA: Day 750 (n=191, 93)
    186 (148 to 234)
    10.2 (8.66 to 12.0)
        Toxin A TNA: Day 930 (n=108, 66)
    173 (125 to 240)
    10.7 (8.57 to 13.4)
        Toxin A TNA: Day 1110 (n=59, 36)
    212 (137 to 329)
    10.2 (8.03 to 12.9)
        Toxin B TNA: Day 0 (n=466, 230)
    12.3 (11.2 to 13.6)
    13.2 (11.2 to 15.6)
        Toxin B TNA: Day 14 (n=419, 216)
    32.7 (25.3 to 42.2)
    13.3 (11.3 to 15.7)
        Toxin B TNA: Day 30 (n=456, 231)
    37.8 (29.3 to 48.8)
    13.4 (11.3 to 15.8)
        Toxin B TNA: Day 60 (n=416, 212)
    43.9 (34.0 to 56.6)
    14.3 (11.9 to 17.2)
        Toxin B TNA: Day 210 (n=354, 181)
    41.4 (32.4 to 53.1)
    13.2 (11.1 to 15.5)
        Toxin B TNA: Day 390 (n=319, 159)
    38.4 (30.0 to 49.0)
    13.5 (11.3 to 16.1)
        Toxin B TNA: Day 570 (n=277, 145)
    35.7 (27.7 to 46.0)
    13.7 (11.3 to 16.8)
        Toxin B TNA: Day 750 (n=191, 93)
    34.3 (25.1 to 46.9)
    14.6 (11.2 to 18.9)
        Toxin B TNA: Day 930 (n=108, 66)
    31.0 (21.1 to 45.6)
    17.0 (12.3 to 23.5)
        Toxin B TNA: Day 1110 (n=59, 36)
    46.8 (26.1 to 84.1)
    14.0 (9.05 to 21.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA

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    End point title
    		 Percentage of Subjects With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA
    End point description
    Percentage of subjects with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by TNA. The 2-sided 95% CI of the percentage was based on Exact method calculations. Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, ‘number of subjects analysed’ = subjects evaluable for this outcome measure and ‘n’ = subjects with available data for each specified category for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 60
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    436
    220
    Units: percentage of subjects
    number (confidence interval 95%)
        Toxin A TNA: >=2 (n=431, 218)
    85.6 (81.9 to 88.8)
    0.5 (0.0 to 2.5)
        Toxin A TNA: >=4 (n=431, 218)
    78.2 (74.0 to 82.0)
    0.5 (0.0 to 2.5)
        Toxin B TNA: >=2 (n=431, 217)
    30.9 (26.5 to 35.5)
    2.8 (1.0 to 5.9)
        Toxin B TNA: >=4 (n=431, 217)
    27.4 (23.2 to 31.8)
    1.8 (0.5 to 4.7)
    No statistical analyses for this end point

    Secondary: Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Subjects With CDI

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    End point title
    		 Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Subjects With CDI
    End point description
    Serum antibody concentrations against toxins A and B were measured by TNA and were expressed as GMT. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR confirmed CDI cases were defined as the number of subjects with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on subjects with protocol-defined CDI cases. Here, ‘n’ = subjects with available data for each specified category for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 0 and Day 60
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    34
    16
    Units: Titer (1/dilution)
    geometric mean (confidence interval 95%)
        Toxin A TNA: Day 0 (n=33, 16)
    12.4 (8.59 to 17.9)
    12.0 (6.27 to 23.0)
        Toxin A TNA: Day 60 (n=30, 16)
    176 (83.4 to 371)
    10.7 (5.77 to 19.7)
        Toxin B TNA: Day 0 (n=33, 16)
    16.7 (9.46 to 29.5)
    11.1 (7.57 to 16.3)
        Toxin B TNA: Day 60 (n=30, 16)
    53.0 (18.3 to 153)
    13.1 (8.11 to 21.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection Site and Systemic Reactions

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection Site and Systemic Reactions
    End point description
    Solicited injection site reactions: Pain: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant;prevents daily activity; Erythema,swelling: Grade 1: >= 25 to <=50 mm, Grade 2: >51 to <=100 mm, Grade 3: >100 mm. Solicited systemic reactions: fever, headache, malaise, myalgia, arthralgia. Fever: Grade 1:>= 38.0°C to <=38.4°C or>= 100.4° Fahrenheit (F) to <=101.1°F, Grade 2:>=38.5°C to <= 38.9°C or >=101.2°F to <=102.0°F, Grade 3:>=39.0°C or >=102.1°F. Headache, malaise, and myalgia: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Arthralgia: Grade 1:free range of motion but complains of pain or discomfort, Grade 2: decreased range of motion due to pain or discomfort, Grade 3:unwilling to move due to pain. All subjects who received vaccine and were evaluable for reactogenicity. ‘n'=subjects with available data for each category for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 6 after any vaccination
    End point values
    		 C. Difficile Vaccine Group Placebo Group
    Number of subjects analysed
    1227
    608
    Units: percentage of subjects
    number (not applicable)
        Injection site Pain (n=1199, 586)
    38.6
    13.5
        Injection site Erythema (n=1196, 587)
    4.2
    0.0
        Injection site Swelling (n=1197, 587)
    3.8
    0.3
        Fever (n=1173, 577)
    4.8
    5.7
        Headache (n=1196, 586)
    25.3
    22.5
        Malaise (n=1196, 586)
    23.9
    19.6
        Myalgia (n=1196, 586)
    26.6
    21.2
        Arthralgia (n=1196, 586)
    19.5
    16.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited adverse event (AE)collected from Day 0 (post-vaccination) upto 30 days after last vaccination (upto 13 months). Solicited Reaction (SR): for 6 days following each vaccination. Serious adverse event (SAE): throughout the study (upto 3 years)
    Adverse event reporting additional description
    Safety Analysis Set included all subejcts who received at least 1 study or control vaccine and analysed according to vaccine received. SR:an AE prelisted (i.e., solicited) in electronic case report form (eCRF) and considered related to vaccination. An unsolicited AE was an observed AE that did not fulfill the prelisted conditions in eCRF.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    C. Difficile Vaccine Group
    Reporting group description
    		 Subjects received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).

    Reporting group title
    Placebo Group
    Reporting group description
    		 Subjects received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).

    Serious adverse events
    		 C. Difficile Vaccine Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1662 / 6113 (27.19%)
    851 / 3057 (27.84%)
         number of deaths (all causes)
    255
    127
         number of deaths resulting from adverse events
    3
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma Gastric
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma Of Colon
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma Pancreas
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adrenal Adenoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Bone Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Neoplasm
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma Recurrent
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma Stage Ii
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Cancer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Cancer Metastatic
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain Neoplasm
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain Neoplasm Malignant
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast Cancer
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast Cancer Metastatic
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast Cancer Stage Ii
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial Carcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Burkitt's Lymphoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carcinoid Tumour Of The Duodenum
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix Carcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cervix Carcinoma Recurrent
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix Carcinoma Stage I
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Lymphocytic Leukaemia
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear Cell Renal Cell Carcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Adenocarcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Cancer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid Tumour
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Adenocarcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Adenoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Neoplasm
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Carcinoma
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Neoplasm
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal Stromal Tumour
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma Multiforme
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic Cancer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatocellular Carcinoma
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intraductal Papillary Mucinous Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kaposi's Sarcoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leiomyosarcoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Cancer Metastatic
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung Carcinoma Cell Type Unspecified Recurrent
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Carcinoma Cell Type Unspecified Stage Iv
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lymphoma
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Neoplasm Of Eye
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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 Renal Pelvis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Pleural Effusion
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Respiratory Tract Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mantle Cell Lymphoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinum Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Lung
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Carcinoma Of The Bladder
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Metastatic Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm Malignant
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Neoplasm Of Thymus
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm Prostate
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine Tumour
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal Marginal Zone B-Cell Lymphoma
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-Small Cell Lung Cancer Recurrent
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Carcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ovarian Cancer
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Ovarian Epithelial Cancer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic Neuroendocrine Tumour
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary Thyroid Cancer
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid Tumour Benign
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma Cell Myeloma
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    17 / 6113 (0.28%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Prostate Cancer Metastatic
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal Adenocarcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal Cancer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary Gland Adenoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary Gland Cancer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Cell Lung Cancer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small Intestine Carcinoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous Cell Carcinoma
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superficial Spreading Melanoma Stage Unspecified
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular Neoplasm
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional Cell Carcinoma
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Cancer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm Ruptured
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic Aneurysm
         subjects affected / exposed
    1 / 6113 (0.02%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Aneurysm Rupture
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic Stenosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Thrombosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Occlusive Disease
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Stenosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory Collapse
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    12 / 6113 (0.20%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential Hypertension
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity Necrosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Artery Occlusion
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    7 / 6113 (0.11%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    9 / 6113 (0.15%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypertensive Emergency
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 6113 (0.03%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic Shock
         subjects affected / exposed
    4 / 6113 (0.07%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Infarction
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-Abdominal Haematoma
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    7 / 6113 (0.11%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral Artery Aneurysm
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Stenosis
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Thrombosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    11 / 6113 (0.18%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    12 / 6113 (0.20%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis Deep
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Thrombotic Syndrome
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Shock Haemorrhagic
         subjects affected / exposed
    5 / 6113 (0.08%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Subclavian Artery Stenosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal Arteritis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thromboangiitis Obliterans
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis Superficial
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicophlebitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose Ulceration
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Insufficiency
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous Thrombosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous Thrombosis Limb
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Artificial Urinary Sphincter Implant
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Pacemaker Battery Replacement
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardioversion
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal Fluid Drainage
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Arthroplasty
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional Drainage
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee Arthroplasty
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee Operation
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leg Amputation
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metatarsal Excision
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroidectomy
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rehabilitation Therapy
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Extraction
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter Site Haemorrhage
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Discomfort
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    50 / 6113 (0.82%)
    19 / 3057 (0.62%)
         occurrences causally related to treatment / all
    0 / 56
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    8 / 6113 (0.13%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 8
    0 / 6
    Device Dislocation
         subjects affected / exposed
    9 / 6113 (0.15%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Failure
         subjects affected / exposed
    3 / 6113 (0.05%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Issue
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Leakage
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Device Malfunction
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Occlusion
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Interaction
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General Symptom
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised Oedema
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia Obstructive
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant Site Haematoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical Device Complication
         subjects affected / exposed
    7 / 6113 (0.11%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-Organ Failure
         subjects affected / exposed
    4 / 6113 (0.07%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    2 / 6113 (0.03%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patient-Device Incompatibility
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perforated Ulcer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    5 / 6113 (0.08%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Pain
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent-Graft Endoleak
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Cardiac Death
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Sudden Death
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Surgical Failure
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic Inflammatory Response Syndrome
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic Shock
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Allergy
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Allergy
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary Immunodeficiency
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    8 / 6113 (0.13%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Enlargement
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female Genital Tract Fistula
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital Prolapse
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cyst
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmenopausal Haemorrhage
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Haemorrhage
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal Haemorrhage
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal Prolapse
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    23 / 6113 (0.38%)
    10 / 3057 (0.33%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 12
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Alveolitis Allergic
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    18 / 6113 (0.29%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Chronic
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (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
    84 / 6113 (1.37%)
    51 / 3057 (1.67%)
         occurrences causally related to treatment / all
    0 / 121
    0 / 71
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Chronic Respiratory Failure
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dyspnoea
         subjects affected / exposed
    12 / 6113 (0.20%)
    15 / 3057 (0.49%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dyspnoea Exertional
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydropneumothorax
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic Pulmonary Fibrosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    6 / 6113 (0.10%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Lung Disorder
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung Hernia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal Disorder
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal Haemorrhage
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive Airways Disorder
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    21 / 6113 (0.34%)
    10 / 3057 (0.33%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pleuritic Pain
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    4 / 6113 (0.07%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    5 / 6113 (0.08%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Congestion
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    23 / 6113 (0.38%)
    17 / 3057 (0.56%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 17
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Pulmonary Fibrosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Hypertension
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Microemboli
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    6 / 6113 (0.10%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Respiratory Acidosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory Arrest
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory Disorder
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Distress
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    16 / 6113 (0.26%)
    12 / 3057 (0.39%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 15
         deaths causally related to treatment / all
    0 / 6
    0 / 6
    Sinus Polyp
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep Apnoea Syndrome
         subjects affected / exposed
    4 / 6113 (0.07%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Asthmaticus
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal Stenosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol Abuse
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Withdrawal Syndrome
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed Suicide
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Conversion Disorder
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    2 / 6113 (0.03%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    4 / 6113 (0.07%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Dependence
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired Self-Care
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Disorder
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    4 / 6113 (0.07%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic Attack
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizoaffective Disorder
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    0 / 6113 (0.00%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Anticoagulation Drug Level Above Therapeutic
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration Bronchial
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Potassium Decreased
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon Dioxide Abnormal
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Pacemaker Evaluation
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulation Time Prolonged
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram St Segment Elevation
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza A Virus Test Positive
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International Normalised Ratio Increased
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen Saturation Decreased
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prothrombin Time Abnormal
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases Increased
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine Output Decreased
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal Wound Dehiscence
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental Overdose
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Postoperative
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal Bite
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    4 / 6113 (0.07%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Injury
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Injury
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Fissure
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Procedure Complication
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Vertebral Fracture
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical Poisoning
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Restenosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dislocation Of Vertebra
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dural Tear
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exposure To Toxic Agent
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural Haematoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    17 / 6113 (0.28%)
    7 / 3057 (0.23%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fat Embolism
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femur Fracture
         subjects affected / exposed
    11 / 6113 (0.18%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    5 / 6113 (0.08%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat Exhaustion
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat Stroke
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    8 / 6113 (0.13%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    4 / 6113 (0.07%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional Hernia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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
    12 / 6113 (0.20%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Dislocation Postoperative
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Injury
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Injury
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Sprain
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    3 / 6113 (0.05%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical Ventilation Complication
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Meniscus Injury
         subjects affected / exposed
    0 / 6113 (0.00%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    0 / 6113 (0.00%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Muscle Rupture
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Strain
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Patella Fracture
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Fracture
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic Fracture
         subjects affected / exposed
    6 / 6113 (0.10%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax Traumatic
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Concussion Syndrome
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Complication
         subjects affected / exposed
    18 / 6113 (0.29%)
    11 / 3057 (0.36%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post Procedural Discharge
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haematoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haematuria
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    3 / 6113 (0.05%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Swelling
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Fever
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Ileus
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Thoracic Procedure Complication
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Postoperative Wound Complication
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Haemorrhage
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Hypotension
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Nausea
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis Fracture
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Laceration Postoperative
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Haematoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    2 / 6113 (0.03%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    2 / 6113 (0.03%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Scrotal Haematoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Injury
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab Wound
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Stress Fracture
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    6 / 6113 (0.10%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subdural Haemorrhage
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    4 / 6113 (0.07%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
         subjects affected / exposed
    4 / 6113 (0.07%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheostomy Malfunction
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Arthritis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Intracranial Haemorrhage
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Injury
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Stricture Postoperative
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Bypass Dysfunction
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Graft Occlusion
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Graft Thrombosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Pseudoaneurysm
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    3 / 6113 (0.05%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Anophthalmos
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Septal Defect
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic Ureter
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    13 / 6113 (0.21%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    56 / 6113 (0.92%)
    22 / 3057 (0.72%)
         occurrences causally related to treatment / all
    0 / 59
    1 / 24
         deaths causally related to treatment / all
    0 / 28
    0 / 9
    Angina Pectoris
         subjects affected / exposed
    19 / 6113 (0.31%)
    10 / 3057 (0.33%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    27 / 6113 (0.44%)
    9 / 3057 (0.29%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Incompetence
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Stenosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    9 / 6113 (0.15%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia Supraventricular
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    42 / 6113 (0.69%)
    14 / 3057 (0.46%)
         occurrences causally related to treatment / all
    0 / 53
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    3 / 6113 (0.05%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Tachycardia
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Thrombosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    5 / 6113 (0.08%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle Branch Block Left
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    10 / 6113 (0.16%)
    8 / 3057 (0.26%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Cardiac Disorder
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    34 / 6113 (0.56%)
    16 / 3057 (0.52%)
         occurrences causally related to treatment / all
    0 / 40
    0 / 36
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Cardiac Failure Acute
         subjects affected / exposed
    16 / 6113 (0.26%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac Failure Chronic
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    69 / 6113 (1.13%)
    29 / 3057 (0.95%)
         occurrences causally related to treatment / all
    1 / 102
    0 / 37
         deaths causally related to treatment / all
    0 / 8
    0 / 3
    Cardiac Tamponade
         subjects affected / exposed
    6 / 6113 (0.10%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Valve Disease
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    10 / 6113 (0.16%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 9
    0 / 2
    Cardiogenic Shock
         subjects affected / exposed
    8 / 6113 (0.13%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Cardiomyopathy
         subjects affected / exposed
    5 / 6113 (0.08%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Cardiopulmonary Failure
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiorenal Syndrome
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor Pulmonale
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    22 / 6113 (0.36%)
    7 / 3057 (0.23%)
         occurrences causally related to treatment / all
    0 / 23
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary Artery Occlusion
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    7 / 6113 (0.11%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Thrombosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart Valve Incompetence
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Heart Disease
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac Thrombus
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left Ventricular Failure
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    27 / 6113 (0.44%)
    16 / 3057 (0.52%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 16
         deaths causally related to treatment / all
    0 / 19
    0 / 6
    Myocardial Ischaemia
         subjects affected / exposed
    8 / 6113 (0.13%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 3
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    5 / 6113 (0.08%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal Angina
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless Electrical Activity
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reperfusion Arrhythmia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sick Sinus Syndrome
         subjects affected / exposed
    2 / 6113 (0.03%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinoatrial Block
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Bradycardia
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress Cardiomyopathy
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachyarrhythmia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid Valve Incompetence
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricle Rupture
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    5 / 6113 (0.08%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Altered State Of Consciousness
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apallic Syndrome
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arachnoid Cyst
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Stem Stroke
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Arteriosclerosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal Tunnel Syndrome
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Artery Stenosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Haemorrhage
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral Infarction
         subjects affected / exposed
    5 / 6113 (0.08%)
    7 / 3057 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cerebral Ischaemia
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Thrombosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    19 / 6113 (0.31%)
    8 / 3057 (0.26%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 8
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Cerebrovascular Disorder
         subjects affected / exposed
    3 / 6113 (0.05%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cervical Myelopathy
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial Syndrome
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Inflammatory Demyelinating Polyradiculoneuropathy
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    11 / 6113 (0.18%)
    9 / 3057 (0.29%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Critical Illness Polyneuropathy
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's Type
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia With Lewy Bodies
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    4 / 6113 (0.07%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness Postural
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic Stroke
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    5 / 6113 (0.08%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Paresis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage Intracranial
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhagic Stroke
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    3 / 6113 (0.05%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegic Migraine
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Encephalopathy
         subjects affected / exposed
    2 / 6113 (0.03%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hydrocephalus
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Encephalopathy
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Encephalopathy
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Intercostal Neuralgia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial Aneurysm
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial Pressure Increased
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Cerebral Infarction
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    11 / 6113 (0.18%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Lacunar Infarction
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Radiculopathy
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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 / 6113 (0.02%)
    0 / 3057 (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
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal Pressure Hydrocephalus
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial Seizures
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocephalus
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Polyneuropathy
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-Traumatic Headache
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular Pain
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular Syndrome
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Epilepticus
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid Haemorrhage
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Syncope
         subjects affected / exposed
    14 / 6113 (0.23%)
    9 / 3057 (0.29%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension Headache
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamus Haemorrhage
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic Encephalopathy
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Global Amnesia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    21 / 6113 (0.34%)
    8 / 3057 (0.26%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal Neuralgia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar Insufficiency
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Cns Origin
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal Cord Paralysis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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
    19 / 6113 (0.31%)
    11 / 3057 (0.36%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Antiphospholipid Syndrome
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemolytic Anaemia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    2 / 6113 (0.03%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic Anaemia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic Anaemia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic Normocytic Anaemia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    Deafness Neurosensory
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniere's Disease
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Hearing Loss
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Positional
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amaurosis Fugax
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphakia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivochalasis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phacolytic Glaucoma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pterygium
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Vein Occlusion
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous Haemorrhage
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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 Adhesions
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abdominal Hernia
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    14 / 6113 (0.23%)
    11 / 3057 (0.36%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Lower
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Wall Haematoma
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fissure
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Change Of Bowel Habit
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colitis
         subjects affected / exposed
    5 / 6113 (0.08%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Microscopic
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic Pseudo-Obstruction
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic Stenosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    9 / 6113 (0.15%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental Pulp Disorder
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Gastroparesis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic Hernia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    8 / 6113 (0.13%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diverticular Perforation
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diverticulum
         subjects affected / exposed
    4 / 6113 (0.07%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical Fistula
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive Duodenitis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive Oesophagitis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Disorder
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Haemorrhage
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Perforation
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastritis
         subjects affected / exposed
    8 / 6113 (0.13%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Erosive
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal Ulcer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Haemorrhagic
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Amyloidosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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
    13 / 6113 (0.21%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Gastrointestinal Hypomotility
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Obstruction
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernial Eventration
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus Hernia
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal Stenosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    6 / 6113 (0.10%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus Paralytic
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    4 / 6113 (0.07%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia, Obstructive
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Haemorrhage
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    6 / 6113 (0.10%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Perforation
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-Abdominal Haemorrhage
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Obstruction
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Polyp
         subjects affected / exposed
    5 / 6113 (0.08%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric Artery Thrombosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric Vein Thrombosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Obstruction
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal Stenosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Varices Haemorrhage
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral Disorder
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Pseudocyst
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    6 / 6113 (0.10%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    4 / 6113 (0.07%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Chronic
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Relapsing
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontal Disease
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal Adhesions
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal Haemorrhage
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Prolapse
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    5 / 6113 (0.08%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spigelian Hernia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis Mesenteric Vessel
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Umbilical Hernia
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia, Obstructive
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    5 / 6113 (0.08%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Varices Oesophageal
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Obstruction
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Stenosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Stone
         subjects affected / exposed
    3 / 6113 (0.05%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 6113 (0.03%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis Acute
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    7 / 6113 (0.11%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    2 / 6113 (0.03%)
    7 / 3057 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    7 / 6113 (0.11%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis Alcoholic
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Polyp
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cirrhosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cyst
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Failure
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hepatitis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Acute
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal Syndrome
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus Ulcer
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Contact
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    24 / 6113 (0.39%)
    13 / 3057 (0.43%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ulcer
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ecchymosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hidradenitis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Erythematous
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    11 / 6113 (0.18%)
    7 / 3057 (0.23%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Stevens-Johnson Syndrome
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Bladder Mass
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Neck Obstruction
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Outlet Obstruction
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus Ureteric
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus Urinary
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis Interstitial
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Nephropathy
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    8 / 6113 (0.13%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lupus Nephritis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Micturition Disorder
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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
    9 / 6113 (0.15%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic Syndrome
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive Uropathy
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    7 / 6113 (0.11%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    31 / 6113 (0.51%)
    8 / 3057 (0.26%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Renal Failure Chronic
         subjects affected / exposed
    17 / 6113 (0.28%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Renal Haemorrhage
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Injury
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Tubular Necrosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangury
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress Urinary Incontinence
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric Stenosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Stenosis
         subjects affected / exposed
    7 / 6113 (0.11%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Incontinence
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    5 / 6113 (0.08%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinoma
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vesicocutaneous Fistula
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal Insufficiency
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism Primary
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid Mass
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing Spondylitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arthralgia
         subjects affected / exposed
    10 / 6113 (0.16%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthrofibrosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    8 / 6113 (0.13%)
    8 / 3057 (0.26%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    3 / 6113 (0.05%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Spinal Stenosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Recurrent Multifocal Osteomyelitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Collagen Disorder
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exostosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture Nonunion
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty Arthritis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Degeneration
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Disorder
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    4 / 6113 (0.07%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Instability
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Swelling
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mobility Decreased
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Necrosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Spasms
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    5 / 6113 (0.08%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck Pain
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    47 / 6113 (0.77%)
    19 / 3057 (0.62%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain In Extremity
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic Arthropathy
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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
    Abdominal Hernia Gangrenous
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Sepsis
         subjects affected / exposed
    2 / 6113 (0.03%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal Wall Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    5 / 6113 (0.08%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous Graft Site Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    11 / 6113 (0.18%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Infective
         subjects affected / exposed
    8 / 6113 (0.13%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asymptomatic Bacteriuria
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical Mycobacterial Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    8 / 6113 (0.13%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Sepsis
         subjects affected / exposed
    4 / 6113 (0.07%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Tracheitis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Beta Haemolytic Streptococcal Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Sepsis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cellulitis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    11 / 6113 (0.18%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis Infective
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida Sepsis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cellulitis
         subjects affected / exposed
    63 / 6113 (1.03%)
    36 / 3057 (1.18%)
         occurrences causally related to treatment / all
    1 / 78
    0 / 41
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Hepatitis C
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue Fever
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermo-Hypodermitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Related Infection
         subjects affected / exposed
    18 / 6113 (0.29%)
    12 / 3057 (0.39%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic Foot Infection
         subjects affected / exposed
    26 / 6113 (0.43%)
    9 / 3057 (0.29%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic Gangrene
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea Infectious
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated Tuberculosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diverticulitis
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis Bacterial
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter Pneumonia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Bacterial
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Infectious
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Bacteraemia
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Sepsis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    10 / 6113 (0.16%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital Herpes
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft Infection
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin Abscess
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cyst Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Virus Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant Site Infection
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision Site Infection
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection In An Immunocompromised Host
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Exacerbation Of Bronchiectasis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Exacerbation Of Chronic Obstructive Airways Disease
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Spondylitis
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    5 / 6113 (0.08%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Discitis
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    4 / 6113 (0.07%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    7 / 6113 (0.11%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection Viral
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    4 / 6113 (0.07%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mumps
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterium Avium Complex Infection
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nail Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological Infection
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    6 / 6113 (0.10%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    27 / 6113 (0.44%)
    11 / 3057 (0.36%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Acute
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Chronic
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Externa
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraspinal Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perihepatic Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    107 / 6113 (1.75%)
    67 / 3057 (2.19%)
         occurrences causally related to treatment / all
    0 / 122
    0 / 84
         deaths causally related to treatment / all
    0 / 7
    0 / 9
    Pneumonia Bacterial
         subjects affected / exposed
    5 / 6113 (0.08%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pneumonia Necrotising
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Pneumococcal
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Staphylococcal
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poliomyelitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Cellulitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Infection
         subjects affected / exposed
    7 / 6113 (0.11%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Pneumonia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Sepsis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    28 / 6113 (0.46%)
    15 / 3057 (0.49%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoas Abscess
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Sepsis
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pulmonary Tuberculosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    5 / 6113 (0.08%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    7 / 6113 (0.11%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    7 / 6113 (0.11%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Scrotal Abscess
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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
    34 / 6113 (0.56%)
    18 / 3057 (0.59%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 18
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Septic Arthritis Staphylococcal
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    26 / 6113 (0.43%)
    13 / 3057 (0.43%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 13
         deaths causally related to treatment / all
    0 / 21
    0 / 8
    Sinusitis Bacterial
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Bacterial Infection
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Infection
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Infection
         subjects affected / exposed
    3 / 6113 (0.05%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Bacteraemia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    4 / 6113 (0.07%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Osteomyelitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Sepsis
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subcutaneous Abscess
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (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
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Bladder Abscess
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    91 / 6113 (1.49%)
    38 / 3057 (1.24%)
         occurrences causally related to treatment / all
    0 / 116
    0 / 47
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    3 / 6113 (0.05%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection Pseudomonal
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    11 / 6113 (0.18%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Viral Infection
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    5 / 6113 (0.08%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection Bacterial
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Central Obesity
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased Appetite
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    5 / 6113 (0.08%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus
         subjects affected / exposed
    12 / 6113 (0.20%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    8 / 6113 (0.13%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Complication
         subjects affected / exposed
    2 / 6113 (0.03%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Diabetic Ketoacidosis
         subjects affected / exposed
    3 / 6113 (0.05%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte Imbalance
         subjects affected / exposed
    2 / 6113 (0.03%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Overload
         subjects affected / exposed
    4 / 6113 (0.07%)
    5 / 3057 (0.16%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    5 / 6113 (0.08%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperamylasaemia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    10 / 6113 (0.16%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic Hyperosmolar Nonketotic Syndrome
         subjects affected / exposed
    3 / 6113 (0.05%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    5 / 6113 (0.08%)
    4 / 3057 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (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
    11 / 6113 (0.18%)
    6 / 3057 (0.20%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 6113 (0.03%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    6 / 6113 (0.10%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 6113 (0.00%)
    1 / 3057 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 6113 (0.00%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Acidosis
         subjects affected / exposed
    0 / 6113 (0.00%)
    3 / 3057 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Obesity
         subjects affected / exposed
    2 / 6113 (0.03%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 Diabetes Mellitus
         subjects affected / exposed
    1 / 6113 (0.02%)
    0 / 3057 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    1 / 6113 (0.02%)
    2 / 3057 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 C. Difficile Vaccine Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1347 / 6113 (22.04%)
    401 / 3057 (13.12%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    531 / 6113 (8.69%)
    229 / 3057 (7.49%)
         occurrences all number
    758
    327
    General disorders and administration site conditions
    Injection Site Pain
         subjects affected / exposed
    855 / 6113 (13.99%)
    127 / 3057 (4.15%)
         occurrences all number
    1252
    157
    Malaise
         subjects affected / exposed
    325 / 6113 (5.32%)
    135 / 3057 (4.42%)
         occurrences all number
    456
    195
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    345 / 6113 (5.64%)
    146 / 3057 (4.78%)
         occurrences all number
    481
    205
    Myalgia
         subjects affected / exposed
    368 / 6113 (6.02%)
    132 / 3057 (4.32%)
         occurrences all number
    556
    201

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Mar 2013
    Following amendments were made:1) European Union Drug Regulating Authorities Clinical Trials (Eudra CT) number added for clinical trial identification required for clinical trial agreement (CTA) submissions, 2) Sponsor’s Responsible Medical Officer changed from Ginamarie Foglia to Guy de Bruyn, 3) Clarified the number of subjects in each of the subsets (immunogenicity and reactogenicity) as part of the total enrolled subjects, 4) Added more information to define Risk Stratum 2 as subjects by specifying that they had to have an impending hospital stay planned to be >=72 hours, 5) Specified collection of AEs from Day 0 to Day 60 as “unsolicited” as per Center for Biologics and Research (CBER) comment provided 06 February 2013, 6) Added text to reinforce that only results from PCR testing performed by the central laboratory was used for analyses of primary efficacy endpoints, 7) Added secondary objectives as per CBER comment provided 08 February 2013 and redefined definition of severe CDI for secondary endpoints, 8) Exploratory objectives reworded and expanded to represent refinement of quality of life objectives , 9) Redefined statistical method explanation of the primary analysis and added statistical methods for the secondary and exploratory objectives as per CBER comment 06 February 2013, 10) Removed requirement for recording vomiting and constipation as symptoms that were tracked in this study, 11) Clarified role of Independent Data Monitoring Committee (IDMC) for the study, 12) Added text to reinforce description of the safety follow-up for at least 6 months after the last injection as per CBER 06 February 2013, 13) Added wording to clarify that some data required for CDI characterization would be obtained from medical records to complete the electronic case report form, 14) Redefined medication to be included in Categories 2 and 3 for concomitant medications.
    24 Jul 2013
    Following changes were made: 1) The abbreviation AlOH was removed and replaced by aluminum hydroxide, aluminum hydroxide adjuvant, or aluminum containing adjuvant depending on the context as per clarification requested by European Health Authorities, 2) Modification made to exclusion criteria 1 to explicitly define use of contraception or abstinence in response to European agency comments.
    07 Mar 2014
    Following changes were made: Inclusion criterion for Risk Stratum 1 changed from hospital stays lasting >= 72 to stays lasting >=24 hours due to increasing pressure by global medical providers to limit hospital stays to less than 72 hours in an effort to increase enrollment.
    28 May 2014
    Following changes were made: 1) Change made in trial design to allow for continuous enrollment based on operational efficiency and no specific safety concerns cited at the time, 2) Clarified that subjects in immunogenicity subset would not provide information on reactogenicitiy.
    23 Jun 2016
    Following changes were made: 1) Adjustments made to interim analysis strategy, including clearly defining the approach statistically, to allow for Sponsor need for timely trial data and decision making, 2) Clarified the end of study procedures in the event of not reaching 250 CDI cases by completion of planned follow-up.
    14 Feb 2017
    Following changes were made: 1) Sample size increased by 10 percent (%) (from 15 000 to 16 500 subject) to compensate for subjects who had not received all 3 vaccinations due to an enrollment pause instituted on 14 July 2016, as well as, for replacing subjects who had early terminated voluntarily and created a higher than expected drop-out, 2) Trial timelines extended due to enrollment pause and vaccination suspension that began 14 July 2016 to allow for analysis of safety data by IDMC, 3) SAE collection was expanded from 6 months after last vaccination to through the end of the trial period and SAEs with an outcome of death or non-fatal SAEs leading to hospitalization were to be submitted for review and adjudicated by a blinded external committee as per IDMC recommendation on 09 January 2017.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Jul 2016
    Sanofi Pasteur paused the enrollment and further vaccination in the trial to investigate a potential safety concern, upon notification by the IDMC. Following further review in December 2016, the IDMC recommended that the trial resume enrollment without modification of the trial eligibility criteria.
    10 Jan 2017
    17 Nov 2017
    Enrollment and vaccination were stopped upon recommendation from the IDMC following completion of the first interim analysis (50 cases of confirmed CDI observed), due to the low probability of achieving study objectives.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated because the IDMC concluded that the probability that the study will meet its primary objective was low.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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