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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients with Pain Due to Osteoarthritis of the Knee or Hip

    Summary
    EudraCT number
    		 2015-003783-36
    Trial protocol
    		 BG   DK   SE   DE   LT   GB   PL   ES   HU   RO   IT  
    Global end of trial date
    15 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2022
    First version publication date
    01 Jul 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    R475-PN-1523
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02683239
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Road, Tarrytown, NY, United States, 10591
    Public contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 844-734-6643, clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 844-734-6643, clinicaltrials@regeneron.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
    15 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in participants with pain due to radiographically-confirmed osteoarthritis (OA) of the knee or hip.
    Protection of trial subjects
    It was the responsibility of both the sponsor and the investigator(s) to ensure that this clinical study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the ICH guidelines for GCP and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 761
    Country: Number of subjects enrolled
    Romania: 406
    Country: Number of subjects enrolled
    Spain: 90
    Country: Number of subjects enrolled
    Sweden: 42
    Country: Number of subjects enrolled
    United Kingdom: 653
    Country: Number of subjects enrolled
    Bulgaria: 202
    Country: Number of subjects enrolled
    Denmark: 135
    Country: Number of subjects enrolled
    Estonia: 26
    Country: Number of subjects enrolled
    Germany: 145
    Country: Number of subjects enrolled
    Hungary: 98
    Country: Number of subjects enrolled
    Lithuania: 40
    Country: Number of subjects enrolled
    Colombia: 123
    Country: Number of subjects enrolled
    Hong Kong: 57
    Country: Number of subjects enrolled
    Mexico: 127
    Country: Number of subjects enrolled
    Peru: 31
    Country: Number of subjects enrolled
    Chile: 163
    Country: Number of subjects enrolled
    South Africa: 547
    Country: Number of subjects enrolled
    Russian Federation: 170
    Country: Number of subjects enrolled
    Ukraine: 180
    Country: Number of subjects enrolled
    United States: 1335
    Worldwide total number of subjects
    5331
    EEA total number of subjects
    1945
    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)
    2695
    From 65 to 84 years
    2609
    85 years and over
    27

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total 13,945 participants were screened. Of those, 8614 were screen failures (14 - Adverse event; 587 - consent withdrawn; 7015 - did not meet criteria; 19 - investigator decision; 66 - lost to follow-up; 910 - Other; 3 - Serious Adverse Event) and 5331 met the eligibility criteria and were randomized to 1 of 7 treatment arms.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fasinumab-matching Placebo Q4W/Q8W
    Arm description
    		 Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Fasinumab-matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of fasinumab-matching placebo into abdomen, thigh, or upper arm.

    Arm title
    		 Fasinumab 1 mg SC Q8W
    Arm description
    		 Participants received fasinumab 1 mg SC injection, Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasinumab
    Investigational medicinal product code
    R475
    Other name
    REGN475
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of fasinumab 1 mg into abdomen, thigh, or upper arm.

    Arm title
    		 Fasinumab 1 mg SC Q4W
    Arm description
    		 Participants received fasinumab 1 mg SC injection, Q4W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasinumab
    Investigational medicinal product code
    R475
    Other name
    REGN475
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of fasinumab 1 mg into abdomen, thigh, or upper arm.

    Arm title
    		 Fasinumab 3 mg SC Q4W
    Arm description
    		 Participants received fasinumab 3 mg SC injection, Q4W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasinumab
    Investigational medicinal product code
    R475
    Other name
    REGN475
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of fasinumab 3 mg into abdomen, thigh, or upper arm.

    Arm title
    		 Fasinumab 6 mg SC Q8W
    Arm description
    		 Participants received fasinumab 6 mg SC injection, Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasinumab
    Investigational medicinal product code
    R475
    Other name
    REGN475
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of fasinumab 6 mg the study drug into abdomen, thigh, or upper arm.

    Arm title
    		 Fasinumab 6 mg SC Q4W
    Arm description
    		 Participants received fasinumab 6 mg SC injection Q4W from Day 1 up to 37 weeks of 52-week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasinumab
    Investigational medicinal product code
    R475
    Other name
    REGN475
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of fasinumab 6 mg the study drug into abdomen, thigh, or upper arm.

    Arm title
    		 Fasinumab 9 mg SC Q4W
    Arm description
    		 Participants received fasinumab 9 mg SC injection, Q4W from Day 1 up to 37 weeks of 52-week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasinumab
    Investigational medicinal product code
    R475
    Other name
    REGN475
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of fasinumab 9 mg the study drug into abdomen, thigh, or upper arm.

    Number of subjects in period 1
    		Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Started
    1260
    971
    975
    214
    1680
    116
    115
    Completed
    800
    738
    756
    94
    935
    56
    44
    Not completed
    460
    233
    219
    120
    745
    60
    71
         Physician decision
    38
    19
    14
    73
    143
    14
    15
         Consent withdrawn by subject
    187
    99
    91
    18
    248
    22
    28
         Adverse event, non-fatal
    64
    39
    42
    16
    189
    9
    9
         Protocol violation
    35
    23
    26
    4
    35
    4
    5
         Death
    9
    5
    8
    -
    12
    1
    -
         Unspecified
    -
    1
    1
    -
    1
    -
    -
         Lost to follow-up
    77
    24
    25
    7
    88
    8
    11
         Lack of efficacy
    50
    23
    12
    2
    29
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fasinumab-matching Placebo Q4W/Q8W
    Reporting group description
    		 Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 1 mg SC Q8W
    Reporting group description
    		 Participants received fasinumab 1 mg SC injection, Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 1 mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 1 mg SC injection, Q4W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 3 mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 3 mg SC injection, Q4W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 6 mg SC Q8W
    Reporting group description
    		 Participants received fasinumab 6 mg SC injection, Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 6 mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 6 mg SC injection Q4W from Day 1 up to 37 weeks of 52-week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 9 mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 9 mg SC injection, Q4W from Day 1 up to 37 weeks of 52-week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W Total
    Number of subjects
    		 1260 971 975 214 1680 116 115 5331
    Age categorical
    Units: Participants
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.7 ( 9.24 ) 65.0 ( 9.24 ) 65.1 ( 8.57 ) 65.3 ( 9.19 ) 62.9 ( 9.61 ) 62.4 ( 8.38 ) 63.4 ( 9.89 ) -
    Gender categorical
    Units: Participants
        Female
    		 913 723 705 149 1237 83 76 3886
        Male
    		 347 248 270 65 443 33 39 1445
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 19 50 53 0 8 0 1 131
        Asian
    		 25 7 9 0 52 0 0 93
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 0 0 1 0 2
        Black or African American
    		 156 64 66 16 213 15 12 542
        White
    		 996 759 738 190 1352 99 102 4236
        Unknown or Not Reported
    		 63 91 109 8 55 1 0 327
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 117 177 182 6 124 8 8 622
        Not Hispanic or Latino
    		 1139 791 787 207 1547 108 107 4686
        Unknown or Not Reported
    		 4 3 6 1 9 0 0 23
    WOMAC Pain Subscale Score
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    		 6.65 ( 1.550 ) 6.70 ( 1.439 ) 6.58 ( 1.491 ) 6.48 ( 1.470 ) 6.58 ( 1.408 ) 99999 ( 99999 ) 99999 ( 99999 ) -
    WOMAC Physical Function Subscale Score
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    		 6.47 ( 1.583 ) 6.56 ( 1.631 ) 6.41 ( 1.495 ) 6.27 ( 1.699 ) 6.38 ( 1.598 ) 99999 ( 99999 ) 99999 ( 99999 ) -
    Patient Global Assessment Score of Osteoarthritis
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    		 3.44 ( 0.847 ) 3.56 ( 0.801 ) 3.47 ( 0.805 ) 3.42 ( 0.783 ) 3.42 ( 0.751 ) 99999 ( 99999 ) 99999 ( 99999 ) -

    End points

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    End points reporting groups
    Reporting group title
    Fasinumab-matching Placebo Q4W/Q8W
    Reporting group description
    		 Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 1 mg SC Q8W
    Reporting group description
    		 Participants received fasinumab 1 mg SC injection, Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 1 mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 1 mg SC injection, Q4W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 3 mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 3 mg SC injection, Q4W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 6 mg SC Q8W
    Reporting group description
    		 Participants received fasinumab 6 mg SC injection, Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 6 mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 6 mg SC injection Q4W from Day 1 up to 37 weeks of 52-week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 9 mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 9 mg SC injection, Q4W from Day 1 up to 37 weeks of 52-week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Primary: Number of Participants With Adverse Events (AEs) During Treatment Period

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    End point title
    		 Number of Participants With Adverse Events (AEs) During Treatment Period [1]
    End point description
    An AE was any untoward medical occurrence in a subject administered a study drug which may or may not have a causal relationship with the study drug. Therefore, an AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. Number of participants with AEs during treatment period were reported. The safety analysis set for the evaluation of long-term safety (SAF-LTS) included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).
    End point type
    Primary
    End point timeframe
    Baseline up to 52 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Number of subjects analysed
    1257
    966
    974
    214
    1677
    116
    115
    Units: Participants
    1055
    840
    885
    185
    1487
    93
    92
    No statistical analyses for this end point

    Primary: Number of Participants With AEs up to 72 Weeks

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    End point title
    		 Number of Participants With AEs up to 72 Weeks [2]
    End point description
    An AE was any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Therefore, an AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. Number of participants with AEs up to 72 weeks were reported. The SAF-LTS included all randomised participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).
    End point type
    Primary
    End point timeframe
    Baseline up to 72 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Number of subjects analysed
    1257
    966
    974
    214
    1677
    116
    115
    Units: Participants
    1112
    867
    902
    192
    1570
    106
    106
    No statistical analyses for this end point

    Primary: Number of Participants With Serious AEs During Treatment Period

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    End point title
    		 Number of Participants With Serious AEs During Treatment Period [3]
    End point description
    An serious AEs was any untoward medical occurrence that: Resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of one’s ability to conduct normal life functions); was a congenital anomaly/birth defect; was an important medical event: Important medical events may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the subject or may require intervention to prevent 1 of the other serious outcomes listed above. Number of subjects with serious AEs during treatment period were reported. The SAF-LTS included all randomised subjects in the overall study who received any study drug; it was based on the treatment-as-received (as treated).
    End point type
    Primary
    End point timeframe
    Baseline up to 52 weeks
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Number of subjects analysed
    1257
    966
    974
    214
    1677
    116
    115
    Units: Participants
    82
    57
    70
    13
    107
    5
    3
    No statistical analyses for this end point

    Primary: Number of Participants With Serious AEs up to 72 Weeks

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    End point title
    		 Number of Participants With Serious AEs up to 72 Weeks [4]
    End point description
    An serious AEs was any untoward medical occurrence that: Resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of one’s ability to conduct normal life functions); was a congenital anomaly/birth defect; was an important medical event: Important medical events may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent 1 of the other serious outcomes listed above. Number of participants with serious AEs up to 72 weeks were reported. The SAF-LTS included all randomised participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).
    End point type
    Primary
    End point timeframe
    Baseline up to 72 weeks
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Number of subjects analysed
    1257
    966
    974
    214
    1677
    116
    115
    Units: Participants
    173
    138
    176
    44
    413
    28
    26
    No statistical analyses for this end point

    Primary: Number of Participants With Adverse Events of Special Interests (AESIs) During Treatment Period

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    End point title
    		 Number of Participants With Adverse Events of Special Interests (AESIs) During Treatment Period [5]
    End point description
    AESIs were followings: Adjudicated arthropathy (as confirmed by adjudication); Sympathetic nervous system dysfunction (as diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist); Peripheral sensory AEs that required a neurology or other specialty consultation; Joint replacement (JR) surgery. Number of participants with AESIs during treatment period were reported. The SAF-LTS included all randomised subjects in the overall study who received any study drug; it was based on the treatment-as-received (as treated).
    End point type
    Primary
    End point timeframe
    Baseline up to 52 weeks
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Number of subjects analysed
    1257
    966
    974
    214
    1677
    116
    115
    Units: Participants
    28
    63
    63
    20
    64
    2
    0
    No statistical analyses for this end point

    Primary: Number of Participants With AESIs up to 72 Weeks

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    End point title
    		 Number of Participants With AESIs up to 72 Weeks [6]
    End point description
    AESIs were followings: Adjudicated arthropathy (as confirmed by adjudication); Sympathetic nervous system dysfunction (as diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist); Peripheral sensory AEs that required a neurology or other specialty consultation; Joint replacement (JR) surgery. Number of participants with AESIs up to 72 weeks were reported. The SAF-LTS included all randomised participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).
    End point type
    Primary
    End point timeframe
    Baseline up to 72 weeks
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Number of subjects analysed
    1257
    966
    974
    214
    1677
    116
    115
    Units: Participants
    80
    150
    159
    41
    382
    22
    14
    No statistical analyses for this end point

    Primary: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values During Treatment Period

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    End point title
    		 Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values During Treatment Period [7]
    End point description
    Number of participants with potentially clinically significant abnormal values in following laboratory parameters hematology, chemistry and urinalysis during treatment period were reported. Clinical significance was determined by the investigator. The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). Here 'n' = number of evaluable participants at the specified timeframe.
    End point type
    Primary
    End point timeframe
    Baseline up to 52 weeks
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Number of subjects analysed
    1257
    966
    974
    214
    1677
    116
    115
    Units: Participants
        Hematology (n=1016, 854, 875, 176, 1405, 88, 85)
    195
    236
    241
    28
    304
    7
    11
        Chemistry (n=1181, 941, 950, 207, 1627, 111, 108)
    403
    365
    403
    105
    717
    36
    34
        Urinalysis (n=1131, 940, 949, 207, 1588, 58, 55)
    32
    42
    45
    2
    55
    1
    1
    No statistical analyses for this end point

    Primary: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to 72 Weeks

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    End point title
    		 Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to 72 Weeks [8]
    End point description
    Number of participants with potentially clinically significant abnormal values in following laboratory parameters hematology, chemistry and urinalysis up to 72 weeks were reported. Clinical significance was determined by the investigator. The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated). Here 'n' = number of evaluable participants at the specified timeframe.
    End point type
    Primary
    End point timeframe
    End of treatment up to 72 weeks
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Number of subjects analysed
    1257
    966
    974
    214
    1677
    116
    115
    Units: Participants
        Hematology (n=1007, 808, 814, 190, 1426,104, 100)
    171
    149
    154
    23
    279
    29
    32
        Chemistry (n=1032, 813, 818, 195, 1459, 107, 100)
    267
    228
    225
    59
    474
    36
    40
        Urinalysis (n=1015, 811, 814, 190, 1442, 103, 99)
    16
    24
    18
    1
    37
    5
    3
    No statistical analyses for this end point

    Primary: Number of Participants With Anti-drug Antibody (ADA) During Treatment Period

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    End point title
    		 Number of Participants With Anti-drug Antibody (ADA) During Treatment Period [9] [10]
    End point description
    Immunogenicity was characterized by ADA responses & titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses less than (<) 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, greater than or equal to (≥) 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the fasinumab ADA assay post first dose when baseline results = negative or missing. The ADA analysis set for the long-term safety population included all participants who received any study drug (SAF-LTS) and had at least 1 non-missing ADA result following the first dose of study drug. Here 'n' = number of evaluable participants during the efficacy sub-study.
    End point type
    Primary
    End point timeframe
    Baseline to 16 weeks
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W
    Number of subjects analysed
    205
    200
    210
    208
    209
    Units: Participants
        ADA Negative Status
    197
    193
    200
    200
    200
        Pre-existing Immunoreactivity
    5
    3
    7
    6
    5
        Treatment-Emergent Response
    3
    4
    3
    2
    4
        Treatment-Boosted Response
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With ADA up to 72 Weeks

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    End point title
    		 Number of Participants With ADA up to 72 Weeks [11]
    End point description
    Immunogenicity was characterized by ADA responses & titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses < 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, ≥9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the fasinumab ADA assay post first dose when baseline results = negative or missing. The ADA analysis set for the long-term safety population included all participants who received any study drug (SAF-LTS) and had at least 1 non-missing ADA result following the first dose of study drug. Here 'n' = number of evaluable participants during the specified time frame.
    End point type
    Primary
    End point timeframe
    Baseline up to 72 weeks
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W Fasinumab 6 mg SC Q4W Fasinumab 9 mg SC Q4W
    Number of subjects analysed
    1153
    911
    929
    208
    1603
    111
    105
    Units: Participants
        ADA Negative Status
    1115
    885
    907
    200
    1547
    108
    104
        Pre-existing Immunoreactivity
    22
    16
    12
    6
    37
    2
    1
        Treatment-Emergent Response
    16
    10
    10
    2
    19
    1
    0
        Treatment-Boosted Response
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Change from Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score

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    End point title
    		 Change from Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score [12]
    End point description
    Here 'n' = number of evaluable participants at the specified time points
    End point type
    Primary
    End point timeframe
    Baseline to Week 16
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W
    Number of subjects analysed
    214
    215
    212
    213
    213
    Units: Score on a Scale
        least squares mean (standard error)
    -1.55 ( 0.178 )
    -2.28 ( 0.175 )
    -2.77 ( 0.171 )
    -2.78 ( 0.174 )
    -2.59 ( 0.174 )
    Statistical analysis title
    		 Placebo vs Fasinumab 1 mg SC Q8W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 1 mg SC Q8W
    Number of subjects included in analysis
    429
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.159
         upper limit
    		 -0.293
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.221
    Statistical analysis title
    		 Placebo vs. Fasinumab 1 mg SC Q4W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 1 mg SC Q4W
    Number of subjects included in analysis
    426
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.646
         upper limit
    		 -0.793
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.217
    Statistical analysis title
    		 Placebo vs. Fasinumab 3 mg SC Q4W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 3 mg SC Q4W
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.664
         upper limit
    		 -0.793
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.222
    Statistical analysis title
    		 Placebo vs. Fasinumab 6 mg SC Q8W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 6 mg SC Q8W
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.477
         upper limit
    		 -0.606
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.222

    Primary: Change from Baseline to Week 16 in WOMAC Physical Function Subscale Score

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    End point title
    		 Change from Baseline to Week 16 in WOMAC Physical Function Subscale Score [13]
    End point description
    Here 'n' = number of evaluable participants at the specified time point
    End point type
    Primary
    End point timeframe
    Baseline to Week 16
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W
    Number of subjects analysed
    207
    212
    212
    208
    209
    Units: Score on a Scale
        least squares mean (standard error)
    -1.35 ( 0.177 )
    -2.09 ( 0.175 )
    -2.55 ( 0.173 )
    -2.61 ( 0.177 )
    -2.48 ( 0.177 )
    Statistical analysis title
    		 Placebo vs. Fasinumab 1 mg SC Q8W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 1 mg SC Q8W
    Number of subjects included in analysis
    419
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.163
         upper limit
    		 -0.309
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.218
    Statistical analysis title
    		 Placebo vs. Fasinumab 1 mg SC Q4W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 1 mg SC Q4W
    Number of subjects included in analysis
    419
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.624
         upper limit
    		 -0.768
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.218
    Statistical analysis title
    		 Placebo vs. Fasinumab 3mg SC Q4W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 3 mg SC Q4W
    Number of subjects included in analysis
    415
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.698
         upper limit
    		 -0.822
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.223
    Statistical analysis title
    		 Placebo vs. Fasinumab 6 mg SC Q8W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 6 mg SC Q8W
    Number of subjects included in analysis
    416
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.564
         upper limit
    		 -0.695
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.222

    Secondary: Change from Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis

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    End point title
    		 Change from Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis [14]
    End point description
    Here 'n' = number of evaluable participants at the specified time point
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W
    Number of subjects analysed
    214
    214
    217
    213
    214
    Units: Score on a Scale
        least squares mean (standard error)
    -0.66 ( 0.070 )
    -0.87 ( 0.071 )
    -0.93 ( 0.069 )
    -0.99 ( 0.071 )
    -0.96 ( 0.072 )
    Statistical analysis title
    		 Placebo vs. Fasinumab 1mg SC Q8W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 1 mg SC Q8W
    Number of subjects included in analysis
    428
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 -0.028
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Statistical analysis title
    		 Placebo vs. Fasinumab 1 mg SC Q4W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 1 mg SC Q4W
    Number of subjects included in analysis
    431
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0025
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.437
         upper limit
    		 -0.093
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.088
    Statistical analysis title
    		 Placebo vs. Fasinumab 3 mg SC Q4W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 3 mg SC Q4W
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.496
         upper limit
    		 -0.145
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Statistical analysis title
    		 Placebo vs. Fasinumab 6 mg SC Q8W
    Comparison groups
    Fasinumab-matching Placebo Q4W/Q8W v Fasinumab 6 mg SC Q8W
    Number of subjects included in analysis
    428
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.466
         upper limit
    		 -0.118
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.089

    Secondary: Percentage Response from Baseline at Week 16 in the WOMAC Pain Subscale Score

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    End point title
    		 Percentage Response from Baseline at Week 16 in the WOMAC Pain Subscale Score [15]
    End point description
    Participants who achieved a response, where response was defined as an improvement by ≥30% in WOMAC pain subscale score; Here 'n' = number of evaluable participants at the specified time point
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Fasinumab-matching Placebo Q4W/Q8W Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q4W Fasinumab 3 mg SC Q4W Fasinumab 6 mg SC Q8W
    Number of subjects analysed
    214
    215
    217
    214
    214
    Units: Percentage of Partipants
    number (not applicable)
        ≥30% reduction from baseline to week 16
    35.5
    50.2
    58.1
    55.1
    53.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to end of follow-up period (Week 72)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 1mg SC Q8W
    Reporting group description
    		 Participants received fasinumab 1 mg SC injection, Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 1mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 1 mg SC injection, Q4W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 3mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 3 mg SC injection, Q4W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 6mg SC Q8W
    Reporting group description
    		 Participants received fasinumab 6 mg SC injection, Q8W from Day 1 up to 52 weeks. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 6mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 6 mg SC injection Q4W from Day 1 up to 37 weeks of 52-week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Reporting group title
    Fasinumab 9mg SC Q4W
    Reporting group description
    		 Participants received fasinumab 9 mg SC injection, Q4W from Day 1 up to 37 weeks of 52-week treatment period. Participants were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact at 52 weeks.

    Serious adverse events
    		 Placebo Fasinumab 1mg SC Q8W Fasinumab 1mg SC Q4W Fasinumab 3mg SC Q4W Fasinumab 6mg SC Q8W Fasinumab 6mg SC Q4W Fasinumab 9mg SC Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    173 / 1257 (13.76%)
    138 / 966 (14.29%)
    176 / 974 (18.07%)
    44 / 214 (20.56%)
    413 / 1677 (24.63%)
    28 / 116 (24.14%)
    26 / 115 (22.61%)
         number of deaths (all causes)
    7
    3
    6
    0
    9
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    2 / 1257 (0.16%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign renal neoplasm
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    2 / 1257 (0.16%)
    3 / 966 (0.31%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    1 / 1257 (0.08%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer stage I
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian neoplasm
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer stage III
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acoustic neuroma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone neoplasm
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cholesteatoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic myelomonocytic leukaemia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma of liver
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammatory carcinoma of breast stage III
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal neoplasm
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superficial spreading melanoma stage unspecified
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thymoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour necrosis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    5 / 1257 (0.40%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic dilatation
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Giant cell arteritis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip arthroplasty
         subjects affected / exposed
    9 / 1257 (0.72%)
    7 / 966 (0.72%)
    7 / 974 (0.72%)
    0 / 214 (0.00%)
    3 / 1677 (0.18%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
    0 / 8
    0 / 0
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    13 / 1257 (1.03%)
    13 / 966 (1.35%)
    11 / 974 (1.13%)
    4 / 214 (1.87%)
    28 / 1677 (1.67%)
    1 / 116 (0.86%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 13
    0 / 11
    0 / 4
    0 / 30
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Knee operation
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract operation
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint arthroplasty
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    3 / 1257 (0.24%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 1257 (0.16%)
    2 / 966 (0.21%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genital haemorrhage
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine adhesions
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial thickening
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    3 / 1257 (0.24%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiglottic cyst
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 1257 (0.08%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    3 / 974 (0.31%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinorrhoea
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal septum disorder
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 1257 (0.08%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mood disorder due to a general medical condition
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device loosening
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase MB increased
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diagnostic procedure
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    3 / 1677 (0.18%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    3 / 1677 (0.18%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    4 / 1677 (0.24%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    3 / 1677 (0.18%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 1257 (0.08%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    3 / 1257 (0.24%)
    0 / 966 (0.00%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    5 / 1677 (0.30%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon dislocation
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    4 / 1677 (0.24%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis postoperative
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural constipation
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural pulmonary embolism
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 1257 (0.16%)
    2 / 966 (0.21%)
    2 / 974 (0.21%)
    1 / 214 (0.47%)
    3 / 1677 (0.18%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    4 / 1677 (0.24%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 1257 (0.24%)
    1 / 966 (0.10%)
    2 / 974 (0.21%)
    3 / 214 (1.40%)
    5 / 1677 (0.30%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
    0 / 3
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 1257 (0.16%)
    3 / 966 (0.31%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 1257 (0.08%)
    3 / 966 (0.31%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bundle branch block right
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Auditory nerve disorder
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    2 / 1257 (0.16%)
    2 / 966 (0.21%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    5 / 1677 (0.30%)
    0 / 116 (0.00%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
    0 / 5
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fistula
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    3 / 974 (0.31%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial spasm
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    2 / 116 (1.72%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 1257 (0.08%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    3 / 1677 (0.18%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    4 / 974 (0.41%)
    1 / 214 (0.47%)
    1 / 1677 (0.06%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Axonal neuropathy
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuralgic amyotrophy
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 1257 (0.32%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular ataxia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Angle closure glaucoma
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open angle glaucoma
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Borderline glaucoma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Maculopathy
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic hernia
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hernial eventration
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Terminal ileitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Internal hernia
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lichen planus
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic angioedema
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin haemorrhage
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder stenosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 1257 (0.16%)
    3 / 966 (0.31%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder prolapse
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    16 / 1257 (1.27%)
    15 / 966 (1.55%)
    20 / 974 (2.05%)
    5 / 214 (2.34%)
    47 / 1677 (2.80%)
    2 / 116 (1.72%)
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 17
    0 / 22
    0 / 5
    0 / 51
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    1 / 214 (0.47%)
    4 / 1677 (0.24%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    1 / 1257 (0.08%)
    1 / 966 (0.10%)
    3 / 974 (0.31%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    3 / 1677 (0.18%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb mass
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    3 / 974 (0.31%)
    0 / 214 (0.00%)
    5 / 1677 (0.30%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    2 / 214 (0.93%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    9 / 1257 (0.72%)
    7 / 966 (0.72%)
    17 / 974 (1.75%)
    5 / 214 (2.34%)
    41 / 1677 (2.44%)
    4 / 116 (3.45%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
    0 / 18
    0 / 5
    0 / 42
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    3 / 1677 (0.18%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rapidly progressive osteoarthritis
         subjects affected / exposed
    8 / 1257 (0.64%)
    23 / 966 (2.38%)
    27 / 974 (2.77%)
    10 / 214 (4.67%)
    157 / 1677 (9.36%)
    8 / 116 (6.90%)
    6 / 115 (5.22%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 23
    0 / 31
    0 / 11
    0 / 199
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    3 / 974 (0.31%)
    0 / 214 (0.00%)
    9 / 1677 (0.54%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 9
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subchondral insufficiency fracture
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    21 / 1677 (1.25%)
    2 / 116 (1.72%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 21
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon pain
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    3 / 1677 (0.18%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    3 / 1677 (0.18%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint stiffness
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Knee deformity
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metatarsalgia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck mass
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyositis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    3 / 974 (0.31%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    3 / 974 (0.31%)
    0 / 214 (0.00%)
    6 / 1677 (0.36%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 1257 (0.08%)
    3 / 966 (0.31%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    1 / 214 (0.47%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 1257 (0.32%)
    1 / 966 (0.10%)
    2 / 974 (0.21%)
    1 / 214 (0.47%)
    7 / 1677 (0.42%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 1
    0 / 7
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    1 / 214 (0.47%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 1257 (0.00%)
    4 / 966 (0.41%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 1257 (0.08%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 1257 (0.00%)
    1 / 966 (0.10%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess intestinal
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    2 / 974 (0.21%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    1 / 116 (0.86%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    1 / 214 (0.47%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic syndrome
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    1 / 1677 (0.06%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 1257 (0.00%)
    0 / 966 (0.00%)
    1 / 974 (0.10%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    2 / 1257 (0.16%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    0 / 1677 (0.00%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 1257 (0.08%)
    0 / 966 (0.00%)
    0 / 974 (0.00%)
    0 / 214 (0.00%)
    2 / 1677 (0.12%)
    0 / 116 (0.00%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Fasinumab 1mg SC Q8W Fasinumab 1mg SC Q4W Fasinumab 3mg SC Q4W Fasinumab 6mg SC Q8W Fasinumab 6mg SC Q4W Fasinumab 9mg SC Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    984 / 1257 (78.28%)
    792 / 966 (81.99%)
    816 / 974 (83.78%)
    178 / 214 (83.18%)
    1443 / 1677 (86.05%)
    95 / 116 (81.90%)
    88 / 115 (76.52%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    53 / 1257 (4.22%)
    48 / 966 (4.97%)
    56 / 974 (5.75%)
    9 / 214 (4.21%)
    63 / 1677 (3.76%)
    5 / 116 (4.31%)
    4 / 115 (3.48%)
         occurrences all number
    60
    53
    62
    10
    77
    7
    5
    Contusion
         subjects affected / exposed
    34 / 1257 (2.70%)
    35 / 966 (3.62%)
    36 / 974 (3.70%)
    7 / 214 (3.27%)
    62 / 1677 (3.70%)
    2 / 116 (1.72%)
    8 / 115 (6.96%)
         occurrences all number
    42
    48
    48
    7
    70
    2
    9
    Vascular disorders
    Hypertension
         subjects affected / exposed
    53 / 1257 (4.22%)
    54 / 966 (5.59%)
    46 / 974 (4.72%)
    6 / 214 (2.80%)
    75 / 1677 (4.47%)
    2 / 116 (1.72%)
    4 / 115 (3.48%)
         occurrences all number
    55
    59
    50
    7
    79
    2
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    395 / 1257 (31.42%)
    370 / 966 (38.30%)
    417 / 974 (42.81%)
    76 / 214 (35.51%)
    554 / 1677 (33.04%)
    34 / 116 (29.31%)
    30 / 115 (26.09%)
         occurrences all number
    1445
    948
    1080
    158
    1833
    124
    73
    Paraesthesia
         subjects affected / exposed
    41 / 1257 (3.26%)
    54 / 966 (5.59%)
    75 / 974 (7.70%)
    13 / 214 (6.07%)
    144 / 1677 (8.59%)
    6 / 116 (5.17%)
    9 / 115 (7.83%)
         occurrences all number
    53
    66
    94
    18
    169
    6
    10
    Hypoaesthesia
         subjects affected / exposed
    34 / 1257 (2.70%)
    25 / 966 (2.59%)
    27 / 974 (2.77%)
    11 / 214 (5.14%)
    99 / 1677 (5.90%)
    5 / 116 (4.31%)
    8 / 115 (6.96%)
         occurrences all number
    42
    32
    31
    14
    127
    6
    12
    Carpal tunnel syndrome
         subjects affected / exposed
    27 / 1257 (2.15%)
    42 / 966 (4.35%)
    49 / 974 (5.03%)
    17 / 214 (7.94%)
    114 / 1677 (6.80%)
    10 / 116 (8.62%)
    10 / 115 (8.70%)
         occurrences all number
    30
    49
    58
    19
    133
    11
    16
    Dizziness
         subjects affected / exposed
    61 / 1257 (4.85%)
    45 / 966 (4.66%)
    48 / 974 (4.93%)
    7 / 214 (3.27%)
    94 / 1677 (5.61%)
    10 / 116 (8.62%)
    7 / 115 (6.09%)
         occurrences all number
    74
    49
    61
    7
    108
    17
    9
    Sciatica
         subjects affected / exposed
    24 / 1257 (1.91%)
    27 / 966 (2.80%)
    33 / 974 (3.39%)
    10 / 214 (4.67%)
    73 / 1677 (4.35%)
    6 / 116 (5.17%)
    3 / 115 (2.61%)
         occurrences all number
    30
    31
    34
    10
    84
    7
    3
    General disorders and administration site conditions
    Peripheral swelling
         subjects affected / exposed
    16 / 1257 (1.27%)
    11 / 966 (1.14%)
    20 / 974 (2.05%)
    5 / 214 (2.34%)
    79 / 1677 (4.71%)
    3 / 116 (2.59%)
    11 / 115 (9.57%)
         occurrences all number
    20
    11
    23
    6
    95
    3
    11
    Oedema peripheral
         subjects affected / exposed
    32 / 1257 (2.55%)
    26 / 966 (2.69%)
    24 / 974 (2.46%)
    9 / 214 (4.21%)
    93 / 1677 (5.55%)
    10 / 116 (8.62%)
    5 / 115 (4.35%)
         occurrences all number
    38
    29
    25
    9
    110
    10
    5
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    110 / 1257 (8.75%)
    91 / 966 (9.42%)
    117 / 974 (12.01%)
    11 / 214 (5.14%)
    118 / 1677 (7.04%)
    5 / 116 (4.31%)
    3 / 115 (2.61%)
         occurrences all number
    159
    148
    175
    14
    188
    5
    4
    Diarrhoea
         subjects affected / exposed
    58 / 1257 (4.61%)
    55 / 966 (5.69%)
    46 / 974 (4.72%)
    10 / 214 (4.67%)
    80 / 1677 (4.77%)
    13 / 116 (11.21%)
    4 / 115 (3.48%)
         occurrences all number
    67
    67
    61
    10
    87
    19
    8
    Nausea
         subjects affected / exposed
    37 / 1257 (2.94%)
    26 / 966 (2.69%)
    22 / 974 (2.26%)
    2 / 214 (0.93%)
    44 / 1677 (2.62%)
    5 / 116 (4.31%)
    7 / 115 (6.09%)
         occurrences all number
    41
    27
    24
    3
    47
    6
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    409 / 1257 (32.54%)
    347 / 966 (35.92%)
    349 / 974 (35.83%)
    68 / 214 (31.78%)
    702 / 1677 (41.86%)
    53 / 116 (45.69%)
    45 / 115 (39.13%)
         occurrences all number
    759
    633
    627
    107
    1322
    115
    81
    Back pain
         subjects affected / exposed
    203 / 1257 (16.15%)
    206 / 966 (21.33%)
    184 / 974 (18.89%)
    30 / 214 (14.02%)
    281 / 1677 (16.76%)
    14 / 116 (12.07%)
    13 / 115 (11.30%)
         occurrences all number
    362
    335
    299
    36
    515
    24
    18
    Pain in extremity
         subjects affected / exposed
    111 / 1257 (8.83%)
    114 / 966 (11.80%)
    123 / 974 (12.63%)
    15 / 214 (7.01%)
    150 / 1677 (8.94%)
    20 / 116 (17.24%)
    12 / 115 (10.43%)
         occurrences all number
    149
    144
    180
    29
    214
    29
    42
    Myalgia
         subjects affected / exposed
    77 / 1257 (6.13%)
    60 / 966 (6.21%)
    56 / 974 (5.75%)
    11 / 214 (5.14%)
    101 / 1677 (6.02%)
    7 / 116 (6.03%)
    4 / 115 (3.48%)
         occurrences all number
    100
    81
    75
    11
    126
    7
    4
    Osteoarthritis
         subjects affected / exposed
    74 / 1257 (5.89%)
    56 / 966 (5.80%)
    73 / 974 (7.49%)
    29 / 214 (13.55%)
    110 / 1677 (6.56%)
    7 / 116 (6.03%)
    6 / 115 (5.22%)
         occurrences all number
    101
    82
    98
    37
    140
    10
    7
    Joint swelling
         subjects affected / exposed
    36 / 1257 (2.86%)
    31 / 966 (3.21%)
    35 / 974 (3.59%)
    15 / 214 (7.01%)
    141 / 1677 (8.41%)
    4 / 116 (3.45%)
    10 / 115 (8.70%)
         occurrences all number
    42
    32
    38
    17
    181
    6
    12
    Rapidly progressive osteoarthritis
         subjects affected / exposed
    22 / 1257 (1.75%)
    47 / 966 (4.87%)
    60 / 974 (6.16%)
    12 / 214 (5.61%)
    151 / 1677 (9.00%)
    10 / 116 (8.62%)
    8 / 115 (6.96%)
         occurrences all number
    23
    50
    62
    13
    187
    10
    10
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    183 / 1257 (14.56%)
    189 / 966 (19.57%)
    210 / 974 (21.56%)
    43 / 214 (20.09%)
    224 / 1677 (13.36%)
    12 / 116 (10.34%)
    18 / 115 (15.65%)
         occurrences all number
    231
    289
    303
    55
    277
    12
    21
    Upper respiratory tract infection
         subjects affected / exposed
    142 / 1257 (11.30%)
    82 / 966 (8.49%)
    89 / 974 (9.14%)
    17 / 214 (7.94%)
    219 / 1677 (13.06%)
    15 / 116 (12.93%)
    10 / 115 (8.70%)
         occurrences all number
    198
    103
    113
    17
    295
    18
    13
    Urinary tract infection
         subjects affected / exposed
    122 / 1257 (9.71%)
    84 / 966 (8.70%)
    124 / 974 (12.73%)
    21 / 214 (9.81%)
    155 / 1677 (9.24%)
    9 / 116 (7.76%)
    6 / 115 (5.22%)
         occurrences all number
    167
    106
    159
    26
    208
    11
    9
    Influenza
         subjects affected / exposed
    69 / 1257 (5.49%)
    54 / 966 (5.59%)
    59 / 974 (6.06%)
    10 / 214 (4.67%)
    103 / 1677 (6.14%)
    3 / 116 (2.59%)
    1 / 115 (0.87%)
         occurrences all number
    88
    59
    66
    10
    119
    3
    1
    Bronchitis
         subjects affected / exposed
    52 / 1257 (4.14%)
    34 / 966 (3.52%)
    33 / 974 (3.39%)
    4 / 214 (1.87%)
    71 / 1677 (4.23%)
    7 / 116 (6.03%)
    3 / 115 (2.61%)
         occurrences all number
    54
    35
    36
    4
    77
    7
    4
    Sinusitis
         subjects affected / exposed
    30 / 1257 (2.39%)
    23 / 966 (2.38%)
    20 / 974 (2.05%)
    5 / 214 (2.34%)
    71 / 1677 (4.23%)
    7 / 116 (6.03%)
    3 / 115 (2.61%)
         occurrences all number
    33
    27
    22
    5
    79
    8
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Dec 2015
    Amendment 1: Added safety and other assessments; Added exclusion criterion
    25 Feb 2016
    Amendment 2: Updated reasons for permanent discontinuation of study drug; Updated inclusion and exclusion criteria
    20 Jun 2016
    Amendment 3: Updated the dose selection, randomization ratio and permitted and prohibited therapy information; Added risk-benefit assessment; Updated and added inclusion criteria; Added chemistry and hematology safety labs and other tests
    25 Aug 2016
    Amendment 4: Updated laboratory and urine collection timepoints and added other tests to better monitor subject safety during the trial
    17 Jan 2017
    Amendment 5: Updated Rationale for Dose Selection; Minor edits and clarifications were made
    16 Mar 2017
    Amendment 6: Update the doses, dosing schedule, and rationale for dose selection; Added an end of study phone contact at 52 weeks following the last dose of study drug; Updated enrollment number and the randomization allocation; Updated the language referring to stopping guidelines for a dose arm, the study or the program; Clarified safety objectives and updated associated endpoints and statistical methods; Simplified the efficacy sub-study objective and updated the associated endpoints and statistical methods; Added an end of study definition; Updated the exclusion criterion; Added additional inclusion and exclusion criteria for the efficacy sub-study; Added additional reasons for permanent discontinuation of study drug; Added a PK sample collection timepoints
    24 May 2018
    Amendment 7: Incorporated an urgent safety measure
    11 Jul 2018
    Amendment 8: Purpose was to gain greater safety exposure to the fasinumab 1 mg dose in the main safety study

    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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