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    Clinical Trial Results:
    An Observational Follow-Up Study for: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium (Protocol 018).

    Summary
    EudraCT number
    		 2013-001526-26
    Trial protocol
    		 IT   LT   DE   EE   LV   ES   CZ   PL   BG   DK   HR  
    Global end of trial date
    23 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 May 2019
    First version publication date
    19 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0822-083
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Registration Number: MK-0822-083
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this observational follow-up study to MK-0822-018 was to collect follow-up safety information on participants who had discontinued from follow-up prior to reaching 5 years after randomization in study MK-0822-083.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 280
    Country: Number of subjects enrolled
    Belgium: 37
    Country: Number of subjects enrolled
    Brazil: 1611
    Country: Number of subjects enrolled
    Bulgaria: 220
    Country: Number of subjects enrolled
    Chile: 62
    Country: Number of subjects enrolled
    China: 610
    Country: Number of subjects enrolled
    Colombia: 1999
    Country: Number of subjects enrolled
    Croatia: 33
    Country: Number of subjects enrolled
    Czech Republic: 317
    Country: Number of subjects enrolled
    Denmark: 1048
    Country: Number of subjects enrolled
    Dominican Republic: 144
    Country: Number of subjects enrolled
    Estonia: 170
    Country: Number of subjects enrolled
    France: 42
    Country: Number of subjects enrolled
    Germany: 27
    Country: Number of subjects enrolled
    Guatemala: 293
    Country: Number of subjects enrolled
    Hong Kong: 211
    Country: Number of subjects enrolled
    Italy: 79
    Country: Number of subjects enrolled
    Japan: 454
    Country: Number of subjects enrolled
    Korea, Republic of: 194
    Country: Number of subjects enrolled
    Latvia: 53
    Country: Number of subjects enrolled
    Lithuania: 178
    Country: Number of subjects enrolled
    Mexico: 421
    Country: Number of subjects enrolled
    New Zealand: 86
    Country: Number of subjects enrolled
    Norway: 289
    Country: Number of subjects enrolled
    Peru: 603
    Country: Number of subjects enrolled
    Philippines: 116
    Country: Number of subjects enrolled
    Poland: 1171
    Country: Number of subjects enrolled
    Romania: 129
    Country: Number of subjects enrolled
    Russian Federation: 793
    Country: Number of subjects enrolled
    Serbia: 60
    Country: Number of subjects enrolled
    South Africa: 1129
    Country: Number of subjects enrolled
    Spain: 61
    Country: Number of subjects enrolled
    Switzerland: 27
    Country: Number of subjects enrolled
    Taiwan: 64
    Country: Number of subjects enrolled
    Ukraine: 84
    Country: Number of subjects enrolled
    United Kingdom: 1711
    Country: Number of subjects enrolled
    United States: 262
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    India: 981
    Country: Number of subjects enrolled
    Lebanon: 19
    Worldwide total number of subjects
    16071
    EEA total number of subjects
    5565
    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)
    12
    From 65 to 84 years
    15650
    85 years and over
    409

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of 16,071 participants who received blinded study treatment during the MK-0822-018 base study and first extension, 2887 participants participated in observational follow-up study MK-0822-083. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension.

    Period 1
    Period 1 title
    018 Base Study and First Extension
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Odanacatib (ODN) 50 mg Once Weekly
    Arm description
    		 Participants receive 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total). Participants also receive 5600 IU Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vitamin D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5600 IU (2 x 2800 IU tablets) administered orally, once weekly, open label

    Investigational medicinal product name
    Odanacatib (ODN)
    Investigational medicinal product code
    MK-0822
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg tablet administered orally, once weekly

    Arm title
    		 Placebo Once Weekly
    Arm description
    		 Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). Participants also received 5600 IU Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vitamin D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5600 IU (2 x 2800 IU tablets) administered orally, once weekly, open label

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet to match ODN 50 mg tablet, administered orally, once weekly

    Number of subjects in period 1
    		Odanacatib (ODN) 50 mg Once Weekly Placebo Once Weekly
    Started
    8043
    8028
    Completed
    3640
    2961
    Not completed
    4403
    5067
         Consent withdrawn by subject
    1358
    1254
         Not Reported
    46
    67
         Physician Decision
    110
    97
         Adverse event, non-fatal
    687
    612
         Completed Base Study, Did Not Enter 1st Extension
    1795
    2238
         Final Disposition Unknown
    -
    1
         Lost to follow-up
    262
    245
         Protocol deviation
    64
    51
         Lack of efficacy
    81
    502
    Period 2
    Period 2 title
    -083 Observational Follow-Up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No study medication was provided as part of this observational follow-up study. However, during this study, sponsor personnel, the study investigator, and the participant remained blinded to the study drug treatment received in MK-0822-018 (Base study and the first Extension study).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Formerly Received Odanacatib (ODN) 50 mg Once Weekly
    Arm description
    		 Participants received no intervention during this study. However, participants in this arm had received 50 mg of ODN once weekly as part of the MK-0822-018 study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Formerly Received Placebo 50 mg Once Weekly (No intervention)
    Arm description
    		 Participants received no intervention during this study. However, participants in this arm had received placebo once weekly as part of the MK-0822-018 study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [1]
    		Formerly Received Odanacatib (ODN) 50 mg Once Weekly Formerly Received Placebo 50 mg Once Weekly (No intervention)
    Started
    1181
    1706
    Completed
    1162
    1673
    Not completed
    19
    33
         Consent withdrawn by subject
    2
    8
         Adverse event, non-fatal
    7
    10
         Other Protocol Specified Criteria
    2
    2
         Unknown: Disposition Record Did Not Exist
    2
    2
         Lost to follow-up
    6
    11
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all participants from the 018 period were required or expected to enter the 083 period. The 083 period is an observational follow-up study for participants who did not complete 5 years of treatment in 018.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Odanacatib (ODN) 50 mg Once Weekly
    Reporting group description
    		 Participants receive 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total). Participants also receive 5600 IU Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.

    Reporting group title
    Placebo Once Weekly
    Reporting group description
    		 Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). Participants also received 5600 IU Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.

    Reporting group values
    		 Odanacatib (ODN) 50 mg Once Weekly Placebo Once Weekly Total
    Number of subjects
    		 8043 8028 16071
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 6 6 12
        From 65-84 years
    		 7826 7824 15650
        85 years and over
    		 211 198 409
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.8 ( 5.4 ) 72.9 ( 5.3 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 8043 8028 16071
        Male
    		 0 0 0
    Race
    Units: Subjects
        American Indian Or Alaska Native
    		 97 88 185
        Asian
    		 1421 1411 2832
        Black Or African American
    		 129 132 261
        Multi-Racial
    		 1867 1839 3706
        Native Hawaiian Or Other Pacific Islander
    		 1 1 2
        White
    		 4528 4557 9085

    End points

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    End points reporting groups
    Reporting group title
    Odanacatib (ODN) 50 mg Once Weekly
    Reporting group description
    		 Participants receive 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total). Participants also receive 5600 IU Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.

    Reporting group title
    Placebo Once Weekly
    Reporting group description
    		 Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). Participants also received 5600 IU Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.
    Reporting group title
    Formerly Received Odanacatib (ODN) 50 mg Once Weekly
    Reporting group description
    		 Participants received no intervention during this study. However, participants in this arm had received 50 mg of ODN once weekly as part of the MK-0822-018 study.

    Reporting group title
    Formerly Received Placebo 50 mg Once Weekly (No intervention)
    Reporting group description
    		 Participants received no intervention during this study. However, participants in this arm had received placebo once weekly as part of the MK-0822-018 study.

    Subject analysis set title
    Participants Who Had Received Odanacatib During the 018 Study
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This set represents data collected on participants during the MK-0822-018 base and first extension study, combined with data collected during the MK-0822-083 observational followup study, inclusive of participants who participated in MK-0822-018 but did not later enroll in MK-0822-083. During the MK-0822-018 study, these participants received oadanacatib 50 mg once weekly.

    Subject analysis set title
    Participants Who Had Received Placebo During the 018 Study
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This set represents data collected on participants during the MK-0822-018 base and first extension study, combined with data collected during the MK-0822-083 observational followup study, inclusive of participants who participated in MK-0822-018 but did not later enroll in MK-0822-083. During the MK-0822-018 study, these participants received placebo once weekly.

    Primary: Number of Participants With Adverse Events (AEs) per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With Adverse Events (AEs) per 100 Patient-Years of Follow-up
    End point description
    The number of participants experiencing ≥1 AE per 100 patient-years of follow-up was presented. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    92.11 (89.98 to 94.27)
    91.42 (89.31 to 93.57)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.33
         upper limit
    		 3.7

    Primary: Number of Participants With Serious AEs per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With Serious AEs per 100 Patient-Years of Follow-up
    End point description
    The number of participants with serious adverse events per 100 patient-years of follow-up was presented. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    9.27 (8.91 to 9.64)
    9.39 (9.03 to 9.76)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 0.4

    Primary: Number of Participants With AEs Leading to Death per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With AEs Leading to Death per 100 Patient-Years of Follow-up
    End point description
    The number of participants with adverse events that led to death per 100 patient-years of follow-up was presented. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    1.19 (1.07 to 1.31)
    1.04 (0.93 to 1.16)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.31

    Primary: Number of Participants With an Atypical Femoral Shaft Fracture Confirmed by Adjudication per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With an Atypical Femoral Shaft Fracture Confirmed by Adjudication per 100 Patient-Years of Follow-up
    End point description
    The number of participants with an atypical femoral shaft fractures confirmed by adjudication per 100 patient-years of follow-up was presented. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    0.03 (0.01 to 0.06)
    0.00 (0.00 to 0.01)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 0.06

    Primary: Number of Participants With Cerebrovascular Events Confirmed by Adjudication per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With Cerebrovascular Events Confirmed by Adjudication per 100 Patient-Years of Follow-up
    End point description
    The number of participants with cerebrovascular events confirmed by adjudication per 100 patient-years of follow-up was presented. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    0.45 (0.38 to 0.53)
    0.38 (0.31 to 0.45)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.18

    Primary: Number of Participants With Cardiovascular Events Confirmed by Adjudication per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With Cardiovascular Events Confirmed by Adjudication per 100 Patient-Years of Follow-up
    End point description
    The number of participants with cardiovascular events confirmed by adjudication per 100 patient-years of follow-up was presented. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    0.92 (0.82 to 1.03)
    0.86 (0.76 to 0.97)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.21

    Primary: Number of Participants With Skin Adverse Events (AEs) reported as an Event of Clinical Interest per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With Skin Adverse Events (AEs) reported as an Event of Clinical Interest per 100 Patient-Years of Follow-up
    End point description
    The number of participants with skin AEs reported as events of clinical interest (ECI) per 100 patient-years of follow-up was presented. Protocol pre-specifed skin AEs considered ECIs included all serious skin AEs, severe skin AEs, or skin AEs with skin thickening and hardening suggestive of morphea or systemic sclerosis (scleroderma). An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    0.15 (0.11 to 0.20)
    0.15 (0.11 to 0.19)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.07

    Primary: Number of Participants With Serious Respiratory Infections Confirmed by Adjudication per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With Serious Respiratory Infections Confirmed by Adjudication per 100 Patient-Years of Follow-up
    End point description
    The number of participants with serious respiratory infections confirmed by adjudication per 100 patient-years of follow-up was presented. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    0.41 (0.34 to 0.48)
    0.48 (0.41 to 0.56)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.03

    Primary: Number of Participants With Osteonecrosis of the Jaw Confirmed by Adjudication per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With Osteonecrosis of the Jaw Confirmed by Adjudication per 100 Patient-Years of Follow-up [1]
    End point description
    The number of participants with osteonecrosis of the jaw confirmed by adjudication per 100 patient-years of follow-up was presented. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    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: Statistical analysis plan stipulated that if osteonecrosis of the jaw occurred in less than 4 participants in a treatment group, then only estimates within each treatment group would be presented. Therefore, per the plan, no statistical analysis is presented.
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8038
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    0.00 (0.00 to 0.01)
    0.00 (0.00 to 0.01)
    No statistical analyses for this end point

    Primary: Number of Participants With Morphea or Systemic Scleroses Confirmed by Adjudication per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With Morphea or Systemic Scleroses Confirmed by Adjudication per 100 Patient-Years of Follow-up
    End point description
    The number of participants with morphea or systemic sclerosis confirmed by adjudication per 100 patient-years of follow-up was presented. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. All participants who received ≥1 dose of study treatment during the MK-0822-018 base study were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    0.05 (0.03 to 0.08)
    0.01 (0.00 to 0.03)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.06

    Primary: Number of Participants With Delayed Fracture Unions Confirmed by Adjudication per 100 Patient-Years of Follow-up

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    End point title
    		 Number of Participants With Delayed Fracture Unions Confirmed by Adjudication per 100 Patient-Years of Follow-up
    End point description
    The number of participants with delayed fracture unions confirmed by adjudication per 100 patient-years of follow-up was presented. Safety data from this follow-up study was pooled and analyzed with safety data from the MK-0822-018 base study and first extension. Participants who received ≥1 dose of study treatment during the MK-0822-018 base study, and who had a fracture confirmed by adjudication during the MK-0822-018 base or first extension study, were included in the analysis, regardless of whether they later enrolled in MK-0822-083.
    End point type
    Primary
    End point timeframe
    Up to approximately 90 months
    End point values
    		 Participants Who Had Received Odanacatib During the 018 Study Participants Who Had Received Placebo During the 018 Study
    Number of subjects analysed
    8043
    8028
    Units: Participants Per 100 Patient-Years
        number (confidence interval 95%)
    0.73 (0.44 to 1.13)
    0.56 (0.34 to 0.88)
    Statistical analysis title
    		 Difference in Rates
    Statistical analysis description
    Miettinen & Nurminen method based 95% confidence interval and rate difference
    Comparison groups
    Participants Who Had Received Odanacatib During the 018 Study v Participants Who Had Received Placebo During the 018 Study
    Number of subjects included in analysis
    16071
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in rates
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.62

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 90 months
    Adverse event reporting additional description
    AEs reported on follow-up arms of this study were pooled and analyzed with AEs from the respective treatment arms of the MK-0822-018 base study and first extension.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Participants Who Had Received Placebo During the 018 Study
    Reporting group description
    		 This set represents data collected on participants during the MK-0822-018 base and first extension study, combined with data collected during the MK-0822-083 observational followup study, inclusive of participants who participated in MK-0822-018 but did not later enroll in MK-0822-083. During the MK-0822-018 study, these participants received placebo once weekly.

    Reporting group title
    Participants Who Had Received Odanacatib During the 018 Study
    Reporting group description
    		 This set represents data collected on participants during the MK-0822-018 base and first extension study, combined with data collected during the MK-0822-083 observational followup study, inclusive of participants who participated in MK-0822-018 but did not later enroll in MK-0822-083. During the MK-0822-018 study, these participants received oadanacatib 50 mg once weekly.

    Serious adverse events
    		 Participants Who Had Received Placebo During the 018 Study Participants Who Had Received Odanacatib During the 018 Study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2566 / 8028 (31.96%)
    2528 / 8043 (31.43%)
         number of deaths (all causes)
    341
    388
         number of deaths resulting from adverse events
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    7 / 8028 (0.09%)
    11 / 8043 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Angiosarcoma metastatic
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    76 / 8028 (0.95%)
    83 / 8043 (1.03%)
         occurrences causally related to treatment / all
    0 / 92
    0 / 98
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    4 / 8028 (0.05%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    4 / 8028 (0.05%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    33 / 8028 (0.41%)
    35 / 8043 (0.44%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 35
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colon cancer
         subjects affected / exposed
    17 / 8028 (0.21%)
    24 / 8043 (0.30%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 24
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Colorectal cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal carcinoma
         subjects affected / exposed
    5 / 8028 (0.06%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    8 / 8028 (0.10%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    4 / 8028 (0.05%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    4 / 8028 (0.05%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Ovarian epithelial cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic carcinoma
         subjects affected / exposed
    9 / 8028 (0.11%)
    14 / 8043 (0.17%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 6
    0 / 8
    Plasma cell myeloma
         subjects affected / exposed
    6 / 8028 (0.07%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland cancer
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    7 / 8028 (0.09%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    13 / 8028 (0.16%)
    14 / 8043 (0.17%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    11 / 8028 (0.14%)
    18 / 8043 (0.22%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    5 / 8028 (0.06%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    5 / 8028 (0.06%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute leukaemia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Adenocarcinoma gastric
         subjects affected / exposed
    5 / 8028 (0.06%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Adenocarcinoma of the cervix
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiosarcoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Benign breast neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign gastric neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign muscle neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign salivary gland neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign vulval neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Bladder neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone neoplasm
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Borderline mucinous tumour of ovary
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    6 / 8028 (0.07%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain cancer metastatic
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer in situ
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Breast cancer recurrent
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage III
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchioloalveolar carcinoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoid tumour of the stomach
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoma in situ of skin
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar tumour
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellopontine angle tumour
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix cancer metastatic
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    3 / 8028 (0.04%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma stage II
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Choroid melanoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    5 / 8028 (0.06%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell endometrial carcinoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Colon neoplasm
         subjects affected / exposed
    4 / 8028 (0.05%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colorectal cancer recurrent
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysplastic naevus
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential thrombocythaemia
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fallopian tube cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female reproductive neoplasm
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fibroadenoma of breast
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibroma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibromatosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicle centre lymphoma, follicular grade I, II, III stage II
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 2
    Gastric cancer
         subjects affected / exposed
    6 / 8028 (0.07%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Gastric cancer stage IV
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal neoplasm
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomus tumour
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of bone
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    4 / 8028 (0.05%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Hepatic neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Inflammatory carcinoma of the breast
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intraductal papilloma of breast
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular melanoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kaposi's sarcoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leiomyoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lentigo maligna
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lip and/or oral cavity cancer
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposarcoma
         subjects affected / exposed
    3 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobular breast carcinoma in situ
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    1 / 8028 (0.01%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Lung adenocarcinoma stage I
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung cancer metastatic
         subjects affected / exposed
    4 / 8028 (0.05%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    23 / 8028 (0.29%)
    13 / 8043 (0.16%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 13
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    Lymphangioma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphoproliferative disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of ampulla of Vater
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 eyelid
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant peritoneal neoplasm
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mantle cell lymphoma
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medullary thyroid cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melanocytic naevus
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melanoma recurrent
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    4 / 8028 (0.05%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Mesothelioma malignant
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metaplastic breast carcinoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastases to peritoneum
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to pleura
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to skin
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic bronchial carcinoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic gastric cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Metastatic salivary gland cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic uterine cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucinous breast carcinoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycosis fungoides
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome transformation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myeloproliferative disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal cavity cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nasal neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngeal cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Neuroendocrine carcinoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neuroendocrine carcinoma metastatic
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal adenocarcinoma
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Oesophageal carcinoma
         subjects affected / exposed
    3 / 8028 (0.04%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oligodendroglioma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Osteoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteosarcoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian adenoma
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ovarian epithelial cancer stage I
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Papillary serous endometrial carcinoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    5 / 8028 (0.06%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic neoplasm
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal mesothelioma malignant
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    4 / 8028 (0.05%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Rectal cancer
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Refractory anaemia with an excess of blasts
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Refractory cytopenia with unilineage dysplasia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    5 / 8028 (0.06%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma stage II
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Schwannoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Small cell lung cancer limited stage
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue neoplasm
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord neoplasm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Splenic marginal zone lymphoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    4 / 8028 (0.05%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Superficial spreading melanoma stage unspecified
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thymoma malignant
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid adenoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer metastatic
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ureteric cancer
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral cancer
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    2 / 8028 (0.02%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine neoplasm
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval cancer
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval cancer stage 0
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    5 / 8028 (0.06%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    10 / 8028 (0.12%)
    17 / 8043 (0.21%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypertension
         subjects affected / exposed
    41 / 8028 (0.51%)
    32 / 8043 (0.40%)
         occurrences causally related to treatment / all
    0 / 43
    1 / 36
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    3 / 8028 (0.04%)
    9 / 8043 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accelerated hypertension
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    4 / 8028 (0.05%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic aneurysm rupture
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arterial disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Bleeding varicose vein
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure fluctuation
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    4 / 8028 (0.05%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Distributive shock
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Essential hypertension
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Femoral artery occlusion
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hot flush
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    20 / 8028 (0.25%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypotension
         subjects affected / exposed
    3 / 8028 (0.04%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypovolaemic shock
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Iliac artery occlusion
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infarction
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    4 / 8028 (0.05%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    5 / 8028 (0.06%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral circulatory failure
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Subgaleal haematoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    4 / 8028 (0.05%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse event
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    26 / 8028 (0.32%)
    22 / 8043 (0.27%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    67 / 8028 (0.83%)
    67 / 8043 (0.83%)
         occurrences causally related to treatment / all
    0 / 67
    0 / 67
         deaths causally related to treatment / all
    0 / 67
    0 / 67
    Device battery issue
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    5 / 8028 (0.06%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    7 / 8028 (0.09%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental death
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Asthenia
         subjects affected / exposed
    3 / 8028 (0.04%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Capsular contracture associated with breast implant
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device adhesion issue
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device breakage
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device damage
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device material issue
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug withdrawal syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial pain
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General symptom
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ill-defined disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Impaired healing
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site reaction
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device complication
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Multi-organ failure
         subjects affected / exposed
    6 / 8028 (0.07%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 6
    0 / 9
    Nodule
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 8028 (0.00%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral administration complication
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    7 / 8028 (0.09%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue inflammation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated hernia
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 8028 (0.02%)
    15 / 8043 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 15
         deaths causally related to treatment / all
    0 / 2
    0 / 15
    Systemic inflammatory response syndrome
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Immobile
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial atrophy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    6 / 8028 (0.07%)
    12 / 8043 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic floor muscle weakness
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    15 / 8028 (0.19%)
    15 / 8043 (0.19%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adnexa uteri mass
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adnexal torsion
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anisomastia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical leukoplakia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical polyp
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colpocele
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    2 / 8028 (0.02%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysfunctional uterine bleeding
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital prolapse
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic pain
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic prolapse
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal fistula
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    10 / 8028 (0.12%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval leukoplakia
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvar dysplasia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    Asthma
         subjects affected / exposed
    19 / 8028 (0.24%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    38 / 8028 (0.47%)
    36 / 8043 (0.45%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 47
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Nasal polyps
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    10 / 8028 (0.12%)
    13 / 8043 (0.16%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 14
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pulmonary embolism
         subjects affected / exposed
    28 / 8028 (0.35%)
    31 / 8043 (0.39%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 32
         deaths causally related to treatment / all
    0 / 9
    0 / 7
    Pulmonary hypertension
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    7 / 8028 (0.09%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Respiratory distress
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    10 / 8028 (0.12%)
    14 / 8043 (0.17%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 15
         deaths causally related to treatment / all
    0 / 6
    0 / 8
    Acute pulmonary oedema
         subjects affected / exposed
    9 / 8028 (0.11%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    4 / 8028 (0.05%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Aspiration
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    5 / 8028 (0.06%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Bronchitis chronic
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    6 / 8028 (0.07%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilic pneumonia chronic
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiglottic cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    2 / 8028 (0.02%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Laryngeal granuloma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal polyp
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung consolidation
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Mediastinal cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophagobronchial fistula
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal pouch
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pickwickian syndrome
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    5 / 8028 (0.06%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Pneumonitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumothorax
         subjects affected / exposed
    3 / 8028 (0.04%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Pulmonary arteriopathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary fibrosis
         subjects affected / exposed
    4 / 8028 (0.05%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Pulmonary ossification
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary thrombosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Respiratory disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract inflammation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus polyp degeneration
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Throat irritation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal stenosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder due to a general medical condition
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    3 / 8028 (0.04%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    10 / 8028 (0.12%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysthymic disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphemia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mood disorder due to a general medical condition
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychogenic pain disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood pressure increased
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grip strength decreased
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    4 / 8028 (0.05%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    21 / 8028 (0.26%)
    13 / 8043 (0.16%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    8 / 8028 (0.10%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Contusion
         subjects affected / exposed
    16 / 8028 (0.20%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    66 / 8028 (0.82%)
    36 / 8043 (0.45%)
         occurrences causally related to treatment / all
    0 / 70
    0 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    42 / 8028 (0.52%)
    46 / 8043 (0.57%)
         occurrences causally related to treatment / all
    0 / 43
    1 / 51
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    12 / 8028 (0.15%)
    11 / 8043 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    11 / 8028 (0.14%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    5 / 8028 (0.06%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    13 / 8028 (0.16%)
    9 / 8043 (0.11%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Heat stroke
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    114 / 8028 (1.42%)
    61 / 8043 (0.76%)
         occurrences causally related to treatment / all
    0 / 115
    0 / 62
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Humerus fracture
         subjects affected / exposed
    51 / 8028 (0.64%)
    30 / 8043 (0.37%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliotibial band syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    7 / 8028 (0.09%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    4 / 8028 (0.05%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    27 / 8028 (0.34%)
    16 / 8043 (0.20%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Meniscus injury
         subjects affected / exposed
    3 / 8028 (0.04%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    10 / 8028 (0.12%)
    11 / 8043 (0.14%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    81 / 8028 (1.01%)
    71 / 8043 (0.88%)
         occurrences causally related to treatment / all
    0 / 83
    0 / 73
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    6 / 8028 (0.07%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    28 / 8028 (0.35%)
    13 / 8043 (0.16%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    23 / 8028 (0.29%)
    13 / 8043 (0.16%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    28 / 8028 (0.35%)
    17 / 8043 (0.21%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    7 / 8028 (0.09%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract stoma complication
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    4 / 8028 (0.05%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    3 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic injury
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial restenosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone fissure
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve rupture
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chillblains
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression fracture
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    8 / 8028 (0.10%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug dispensing error
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Face injury
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    2 / 8028 (0.02%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured ischium
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hand fracture
         subjects affected / exposed
    4 / 8028 (0.05%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat exhaustion
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat illness
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    4 / 8028 (0.05%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth injury
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Muscle injury
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    11 / 8028 (0.14%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal injury
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post procedural discomfort
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural inflammation
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural oedema
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative adhesion
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative hernia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    10 / 8028 (0.12%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Road traffic accident
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Scapula fracture
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scar
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 8028 (0.00%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Spinal compression fracture
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Splenic rupture
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    3 / 8028 (0.04%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sternal injury
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    5 / 8028 (0.06%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial rupture
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic shock
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulnar nerve injury
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular injury
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 8028 (0.00%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital bronchiectasis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital cystic kidney disease
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exomphalos
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    59 / 8028 (0.73%)
    56 / 8043 (0.70%)
         occurrences causally related to treatment / all
    0 / 64
    2 / 58
         deaths causally related to treatment / all
    0 / 14
    0 / 16
    Angina pectoris
         subjects affected / exposed
    44 / 8028 (0.55%)
    40 / 8043 (0.50%)
         occurrences causally related to treatment / all
    0 / 47
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    8 / 8028 (0.10%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    4 / 8028 (0.05%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    85 / 8028 (1.06%)
    76 / 8043 (0.94%)
         occurrences causally related to treatment / all
    0 / 104
    0 / 89
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Atrial flutter
         subjects affected / exposed
    7 / 8028 (0.09%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    6 / 8028 (0.07%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bradycardia
         subjects affected / exposed
    7 / 8028 (0.09%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    13 / 8028 (0.16%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 12
    0 / 7
    Cardiac disorder
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    44 / 8028 (0.55%)
    37 / 8043 (0.46%)
         occurrences causally related to treatment / all
    0 / 47
    0 / 40
         deaths causally related to treatment / all
    0 / 9
    0 / 9
    Cardiac failure chronic
         subjects affected / exposed
    3 / 8028 (0.04%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    36 / 8028 (0.45%)
    39 / 8043 (0.48%)
         occurrences causally related to treatment / all
    2 / 38
    0 / 40
         deaths causally related to treatment / all
    0 / 5
    0 / 8
    Cardio-respiratory arrest
         subjects affected / exposed
    17 / 8028 (0.21%)
    11 / 8043 (0.14%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
         deaths causally related to treatment / all
    0 / 14
    0 / 11
    Coronary artery disease
         subjects affected / exposed
    32 / 8028 (0.40%)
    32 / 8043 (0.40%)
         occurrences causally related to treatment / all
    1 / 35
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypertensive heart disease
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    49 / 8028 (0.61%)
    47 / 8043 (0.58%)
         occurrences causally related to treatment / all
    0 / 52
    0 / 50
         deaths causally related to treatment / all
    0 / 19
    0 / 16
    Myocardial ischaemia
         subjects affected / exposed
    15 / 8028 (0.19%)
    19 / 8043 (0.24%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 21
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Sinus node dysfunction
         subjects affected / exposed
    10 / 8028 (0.12%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    9 / 8028 (0.11%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adams-Stokes syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    34 / 8028 (0.42%)
    34 / 8043 (0.42%)
         occurrences causally related to treatment / all
    1 / 37
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular dissociation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 8028 (0.01%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block bilateral
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block right
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac tamponade
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    3 / 8028 (0.04%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 5
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiovascular disorder
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cor pulmonale acute
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery perforation
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytotoxic cardiomyopathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive cardiomyopathy
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Left ventricular failure
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Microvascular coronary artery disease
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve disease
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mitral valve stenosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pericardial haemorrhage
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Postinfarction angina
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    4 / 8028 (0.05%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia paroxysmal
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ventricular dysfunction
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery occlusion
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    4 / 8028 (0.05%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral arteriosclerosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    10 / 8028 (0.12%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Cerebral infarction
         subjects affected / exposed
    19 / 8028 (0.24%)
    32 / 8043 (0.40%)
         occurrences causally related to treatment / all
    0 / 19
    2 / 33
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cerebral ischaemia
         subjects affected / exposed
    9 / 8028 (0.11%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    46 / 8028 (0.57%)
    72 / 8043 (0.90%)
         occurrences causally related to treatment / all
    1 / 47
    2 / 72
         deaths causally related to treatment / all
    0 / 8
    0 / 10
    Cerebrovascular disorder
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    4 / 8028 (0.05%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dizziness
         subjects affected / exposed
    8 / 8028 (0.10%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    3 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    3 / 8028 (0.04%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential tremor
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    41 / 8028 (0.51%)
    40 / 8043 (0.50%)
         occurrences causally related to treatment / all
    0 / 42
    0 / 42
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Lacunar infarction
         subjects affected / exposed
    9 / 8028 (0.11%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelitis transverse
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Radicular syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatic nerve palsy
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    20 / 8028 (0.25%)
    32 / 8043 (0.40%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Transient ischaemic attack
         subjects affected / exposed
    35 / 8028 (0.44%)
    34 / 8043 (0.42%)
         occurrences causally related to treatment / all
    0 / 38
    2 / 37
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apallic syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia haemorrhage
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Basal ganglia infarction
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain oedema
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain stem stroke
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery aneurysm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery thrombosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid sinus syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    5 / 8028 (0.06%)
    9 / 8043 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery embolism
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral circulatory failure
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral thrombosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral venous thrombosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical myelopathy
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    3 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Complex partial seizures
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cranial nerve disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    4 / 8028 (0.05%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Depressed level of consciousness
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         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
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyslalia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    3 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frontotemporal dementia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    6 / 8028 (0.07%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 8
    Headache
         subjects affected / exposed
    4 / 8028 (0.05%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    3 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertonia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    IIIrd nerve paralysis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial venous sinus thrombosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic neuropathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    8 / 8028 (0.10%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningorrhagia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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 / 8028 (0.01%)
    0 / 8043 (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
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Morton's neuralgia
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuritis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral nerve lesion
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    4 / 8028 (0.05%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sciatica
         subjects affected / exposed
    6 / 8028 (0.07%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sedation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    5 / 8028 (0.06%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory disturbance
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Senile dementia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Slow speech
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    5 / 8028 (0.06%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Thrombotic stroke
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    4 / 8028 (0.05%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White matter lesion
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    22 / 8028 (0.27%)
    16 / 8043 (0.20%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    5 / 8028 (0.06%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia megaloblastic
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic diathesis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pernicious anaemia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    5 / 8028 (0.06%)
    16 / 8043 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    2 / 8028 (0.02%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute vestibular syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    External ear disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inner ear disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniere's disease
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosensory hypoacusis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otosclerosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    84 / 8028 (1.05%)
    99 / 8043 (1.23%)
         occurrences causally related to treatment / all
    0 / 114
    0 / 133
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract subcapsular
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    4 / 8028 (0.05%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Age-related macular degeneration
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amaurosis fugax
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angle closure glaucoma
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chalazion
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choroiditis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ciliary body disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal opacity
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystoid macular oedema
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Entropion
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Excessive eye blinking
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    3 / 8028 (0.04%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iritis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis interstitial
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratopathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacrimal disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lens disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular fibrosis
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Maculopathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neovascular age-related macular degeneration
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic atrophy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior capsule opacification
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery embolism
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal degeneration
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    4 / 8028 (0.05%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal dystrophy
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trichiasis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcerative keratitis
         subjects affected / exposed
    3 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    11 / 8028 (0.14%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal prolapse
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    7 / 8028 (0.09%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    10 / 8028 (0.12%)
    9 / 8043 (0.11%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    3 / 8028 (0.04%)
    9 / 8043 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    3 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    6 / 8028 (0.07%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    9 / 8028 (0.11%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Gastroduodenitis
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    10 / 8028 (0.12%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    8 / 8028 (0.10%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Inguinal hernia
         subjects affected / exposed
    12 / 8028 (0.15%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    11 / 8028 (0.14%)
    11 / 8043 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 13
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Irritable bowel syndrome
         subjects affected / exposed
    4 / 8028 (0.05%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    6 / 8028 (0.07%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pancreatitis chronic
         subjects affected / exposed
    7 / 8028 (0.09%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    12 / 8028 (0.15%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Abdominal adhesions
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia obstructive
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal pain lower
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    2 / 8028 (0.02%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anal fissure
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal inflammation
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal stenosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Change of bowel habit
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    5 / 8028 (0.06%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    6 / 8028 (0.07%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis microscopic
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    10 / 8028 (0.12%)
    9 / 8043 (0.11%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Crohn's disease
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental caries
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    8 / 8028 (0.10%)
    12 / 8043 (0.15%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum oesophageal
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dolichocolon acquired
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    3 / 8028 (0.04%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Duodenitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysbacteriosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocele
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecal incontinence
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral hernia
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral hernia incarcerated
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Functional gastrointestinal disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric antral vascular ectasia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    4 / 8028 (0.05%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (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
    10 / 8028 (0.12%)
    19 / 8043 (0.24%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    7 / 8028 (0.09%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Gastrointestinal inflammation
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal necrosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    10 / 8028 (0.12%)
    11 / 8043 (0.14%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernial eventration
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    3 / 8028 (0.04%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal mass
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal polyp
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal prolapse
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischiorectal hernia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    10 / 8028 (0.12%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar hernia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery embolism
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal fistula
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal hypomotility
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal pain
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis ulcerative
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral pain
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    6 / 8028 (0.07%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis necrotising
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    5 / 8028 (0.06%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer perforation
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngo-oesophageal diverticulum
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal polyp
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    3 / 8028 (0.04%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland calculus
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    5 / 8028 (0.06%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic artery aneurysm
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomach mass
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Toothache
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    3 / 8028 (0.04%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    6 / 8028 (0.07%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    5 / 8028 (0.06%)
    11 / 8043 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    15 / 8028 (0.19%)
    21 / 8043 (0.26%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    39 / 8028 (0.49%)
    34 / 8043 (0.42%)
         occurrences causally related to treatment / all
    0 / 43
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    5 / 8028 (0.06%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bile duct obstruction
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary fistula
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    15 / 8028 (0.19%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic hepatitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    4 / 8028 (0.05%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis cholestatic
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal failure
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Jaundice
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post cholecystectomy syndrome
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    Decubitus ulcer
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subacute cutaneous lupus erythematosus
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Actinic keratosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute generalised exanthematous pustulosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    4 / 8028 (0.05%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blister
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermal cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis atopic
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis contact
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatomyositis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    4 / 8028 (0.05%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema multiforme
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema nodosum
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand dermatitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Henoch-Schonlein purpura
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkeratosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity vasculitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lentigo
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lichen sclerosus
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurodermatitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus generalised
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyoderma gangrenosum
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (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
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash generalised
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    6 / 8028 (0.07%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin wrinkling
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    7 / 8028 (0.09%)
    7 / 8043 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Bladder prolapse
         subjects affected / exposed
    7 / 8028 (0.09%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    11 / 8028 (0.14%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal artery stenosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute prerenal failure
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder diverticulum
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder irritation
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder perforation
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus ureteric
         subjects affected / exposed
    5 / 8028 (0.06%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urethral
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 8028 (0.01%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 3
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Glomerulonephritis membranous
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis rapidly progressive
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    5 / 8028 (0.06%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertonic bladder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pollakiuria
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    4 / 8028 (0.05%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    4 / 8028 (0.05%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Renal impairment
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scleroderma renal crisis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    3 / 8028 (0.04%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral caruncle
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral polyp
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    4 / 8028 (0.05%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    7 / 8028 (0.09%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism primary
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic nodular goitre
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal haemorrhage
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal insufficiency
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperadrenalism
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary hypothyroidism
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary hyperthyroidism
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroiditis subacute
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 8028 (0.10%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    10 / 8028 (0.12%)
    14 / 8043 (0.17%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture delayed union
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    11 / 8028 (0.14%)
    14 / 8043 (0.17%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    8 / 8028 (0.10%)
    9 / 8043 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 8028 (0.01%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    123 / 8028 (1.53%)
    147 / 8043 (1.83%)
         occurrences causally related to treatment / all
    0 / 141
    0 / 167
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    12 / 8028 (0.15%)
    18 / 8043 (0.22%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    8 / 8028 (0.10%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    3 / 8028 (0.04%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    8 / 8028 (0.10%)
    12 / 8043 (0.15%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atlantoaxial instability
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Axillary mass
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    22 / 8028 (0.27%)
    20 / 8043 (0.25%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone loss
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Connective tissue disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilic fasciitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facet joint syndrome
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture malunion
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture pain
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         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 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc space narrowing
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint adhesion
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint contracture
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint range of motion decreased
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint stiffness
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee deformity
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monarthritis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Morphoea
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal osteoarthritis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondritis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteosclerosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 8028 (0.01%)
    9 / 8043 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periostitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plantar fasciitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    5 / 8028 (0.06%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    7 / 8028 (0.09%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scleroderma
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sjogren's syndrome
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue necrosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    17 / 8028 (0.21%)
    15 / 8043 (0.19%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    1 / 8028 (0.01%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis stenosans
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulnocarpal abutment syndrome
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendiceal abscess
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    13 / 8028 (0.16%)
    20 / 8043 (0.25%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    16 / 8028 (0.20%)
    16 / 8043 (0.20%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    17 / 8028 (0.21%)
    19 / 8043 (0.24%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 20
         deaths causally related to treatment / all
    0 / 5
    0 / 7
    Cellulitis
         subjects affected / exposed
    16 / 8028 (0.20%)
    17 / 8043 (0.21%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    29 / 8028 (0.36%)
    35 / 8043 (0.44%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    5 / 8028 (0.06%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    8 / 8028 (0.10%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    11 / 8028 (0.14%)
    15 / 8043 (0.19%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 15
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Peritonitis
         subjects affected / exposed
    6 / 8028 (0.07%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Pneumonia
         subjects affected / exposed
    128 / 8028 (1.59%)
    119 / 8043 (1.48%)
         occurrences causally related to treatment / all
    0 / 133
    0 / 138
         deaths causally related to treatment / all
    0 / 24
    0 / 23
    Pulmonary sepsis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    8 / 8028 (0.10%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    3 / 8028 (0.04%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    19 / 8028 (0.24%)
    23 / 8043 (0.29%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 24
         deaths causally related to treatment / all
    0 / 10
    0 / 14
    Urinary tract infection
         subjects affected / exposed
    54 / 8028 (0.67%)
    54 / 8043 (0.67%)
         occurrences causally related to treatment / all
    1 / 64
    1 / 58
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Wound infection
         subjects affected / exposed
    8 / 8028 (0.10%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal wall abscess
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic colitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burn infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system viral infection
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chlamydial infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cutaneous tuberculosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    8 / 8028 (0.10%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dacryocystitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    5 / 8028 (0.06%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    20 / 8028 (0.25%)
    25 / 8043 (0.31%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dysentery
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Erysipelas
         subjects affected / exposed
    5 / 8028 (0.06%)
    6 / 8043 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema migrans
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastritis viral
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Graft infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex encephalitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Herpes zoster infection neurological
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected bites
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected varicose vein
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal fistula infection
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis bacterial
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lobar pneumonia
         subjects affected / exposed
    12 / 8028 (0.15%)
    11 / 8043 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    5 / 8028 (0.06%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    4 / 8028 (0.05%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    3 / 8028 (0.04%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic abscess
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic sepsis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    3 / 8028 (0.04%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia necrotising
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    2 / 8028 (0.02%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    5 / 8028 (0.06%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary echinococciasis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelocystitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 8028 (0.00%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyometra
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyonephrosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    7 / 8028 (0.09%)
    12 / 8043 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 5
    0 / 10
    Sialoadenitis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinobronchitis
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    2 / 8028 (0.02%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site abscess
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    4 / 8028 (0.05%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tick-borne fever
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tooth infection
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 8028 (0.00%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    4 / 8028 (0.05%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Vaginal abscess
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    2 / 8028 (0.02%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    3 / 8028 (0.04%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral labyrinthitis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         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
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    7 / 8028 (0.09%)
    14 / 8043 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Folate deficiency
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    7 / 8028 (0.09%)
    10 / 8043 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    16 / 8028 (0.20%)
    9 / 8043 (0.11%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    10 / 8028 (0.12%)
    5 / 8043 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    9 / 8028 (0.11%)
    8 / 8043 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 8028 (0.02%)
    4 / 8043 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    2 / 8028 (0.02%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gout
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    3 / 8028 (0.04%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 8028 (0.01%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperosmolar state
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    3 / 8028 (0.04%)
    3 / 8043 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypophagia
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 8028 (0.01%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolic acidosis
         subjects affected / exposed
    0 / 8028 (0.00%)
    1 / 8043 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic disorder
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 8028 (0.01%)
    0 / 8043 (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
    3 / 8028 (0.04%)
    2 / 8043 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    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
    		 Participants Who Had Received Placebo During the 018 Study Participants Who Had Received Odanacatib During the 018 Study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5525 / 8028 (68.82%)
    5577 / 8043 (69.34%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    424 / 8028 (5.28%)
    388 / 8043 (4.82%)
         occurrences all number
    572
    502
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1093 / 8028 (13.61%)
    1110 / 8043 (13.80%)
         occurrences all number
    1288
    1270
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    485 / 8028 (6.04%)
    495 / 8043 (6.15%)
         occurrences all number
    567
    577
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    502 / 8028 (6.25%)
    477 / 8043 (5.93%)
         occurrences all number
    586
    552
    Eye disorders
    Cataract
         subjects affected / exposed
    501 / 8028 (6.24%)
    494 / 8043 (6.14%)
         occurrences all number
    664
    646
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    508 / 8028 (6.33%)
    494 / 8043 (6.14%)
         occurrences all number
    556
    549
    Diarrhoea
         subjects affected / exposed
    504 / 8028 (6.28%)
    591 / 8043 (7.35%)
         occurrences all number
    608
    728
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    469 / 8028 (5.84%)
    471 / 8043 (5.86%)
         occurrences all number
    552
    553
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1155 / 8028 (14.39%)
    1223 / 8043 (15.21%)
         occurrences all number
    1541
    1590
    Back pain
         subjects affected / exposed
    1139 / 8028 (14.19%)
    1200 / 8043 (14.92%)
         occurrences all number
    1400
    1480
    Musculoskeletal pain
         subjects affected / exposed
    464 / 8028 (5.78%)
    519 / 8043 (6.45%)
         occurrences all number
    542
    590
    Osteoarthritis
         subjects affected / exposed
    752 / 8028 (9.37%)
    794 / 8043 (9.87%)
         occurrences all number
    926
    992
    Pain in extremity
         subjects affected / exposed
    675 / 8028 (8.41%)
    753 / 8043 (9.36%)
         occurrences all number
    802
    925
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    461 / 8028 (5.74%)
    452 / 8043 (5.62%)
         occurrences all number
    615
    600
    Influenza
         subjects affected / exposed
    443 / 8028 (5.52%)
    497 / 8043 (6.18%)
         occurrences all number
    565
    613
    Nasopharyngitis
         subjects affected / exposed
    940 / 8028 (11.71%)
    957 / 8043 (11.90%)
         occurrences all number
    1368
    1397
    Upper respiratory tract infection
         subjects affected / exposed
    600 / 8028 (7.47%)
    646 / 8043 (8.03%)
         occurrences all number
    919
    968
    Urinary tract infection
         subjects affected / exposed
    1702 / 8028 (21.20%)
    1729 / 8043 (21.50%)
         occurrences all number
    2831
    2921

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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

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