Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2012-003686-17
    Trial protocol
    		 IT   SK   CZ   BE   PL   SE   GB   HU   AT   DK   DE   PT   NL   ES   LV   LT   GR   SI   HR   FR  
    Global end of trial date
    12 Nov 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 May 2022
    First version publication date
    27 Nov 2021
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    New data added to full data set

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I4V-MC-JADY
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01885078
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14060
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 877 CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 877 285-4559,
    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
    12 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the long-term safety and tolerability of baricitinib.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 72
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 156
    Country: Number of subjects enrolled
    Portugal: 11
    Country: Number of subjects enrolled
    Slovakia: 27
    Country: Number of subjects enrolled
    Slovenia: 5
    Country: Number of subjects enrolled
    Spain: 86
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    United Kingdom: 26
    Country: Number of subjects enrolled
    Croatia: 9
    Country: Number of subjects enrolled
    Austria: 17
    Country: Number of subjects enrolled
    Belgium: 41
    Country: Number of subjects enrolled
    Czechia: 56
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    France: 36
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Hungary: 60
    Country: Number of subjects enrolled
    Italy: 27
    Country: Number of subjects enrolled
    Latvia: 8
    Country: Number of subjects enrolled
    Lithuania: 21
    Country: Number of subjects enrolled
    United States: 488
    Country: Number of subjects enrolled
    Canada: 47
    Country: Number of subjects enrolled
    Argentina: 430
    Country: Number of subjects enrolled
    Australia: 32
    Country: Number of subjects enrolled
    Brazil: 30
    Country: Number of subjects enrolled
    India: 71
    Country: Number of subjects enrolled
    Israel: 27
    Country: Number of subjects enrolled
    China: 208
    Country: Number of subjects enrolled
    Japan: 328
    Country: Number of subjects enrolled
    Mexico: 214
    Country: Number of subjects enrolled
    Romania: 21
    Country: Number of subjects enrolled
    Russian Federation: 122
    Country: Number of subjects enrolled
    South Africa: 56
    Country: Number of subjects enrolled
    Taiwan: 81
    Country: Number of subjects enrolled
    Switzerland: 7
    Country: Number of subjects enrolled
    Turkey: 3
    Worldwide total number of subjects
    2876
    EEA total number of subjects
    634
    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)
    2358
    From 65 to 84 years
    517
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were eligible to participate in the Step-down period if they achieved a sustained (at least 3 months in JADY) low disease activity (CDAI score ≤10; for participants originating in Studies JADV, JADX, JADW, and JAGS) or sustained remission (CDAI score ≤2.8; for participants originating in Study JADZ).

    Pre-assignment
    Screening details
    		 Participants who completed an originating study: I4V-MC-JADZ (NCT01711359), I4V-MC-JADV (NCT017103580, I4V-MC-JADX (NCT01721057), I4V-MC-JADW (NCT01721044), I4V-MC-JADA (NCT01185353), or I4V-MC-JAGS (NCT02265705) were eligible for enrollment into study JADY.

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 JADZ 4 mg Baricitinib
    Arm description
    		 4 mg Baricitinib administered orally once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg Baricitinib administered orally once daily.

    Arm title
    		 JADV 4 mg Baricitinib
    Arm description
    		 4 mg Baricitinib administered orally once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg Baricitinib administered orally once daily.

    Arm title
    		 JADX 2 mg Baricitinib
    Arm description
    		 2 mg Baricitinib administered orally once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 mg Baricitinib administered orally once daily.

    Arm title
    		 JADX 4 mg Baricitinib
    Arm description
    		 4 mg Baricitinib administered orally once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg Baricitinib administered orally once daily.

    Arm title
    		 JADW 2 mg Baricitinib
    Arm description
    		 2 mg Baricitinib administered orally once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 mg Baricitinib administered orally once daily.

    Arm title
    		 JADW 4 mg Baricitinib
    Arm description
    		 4 mg Baricitinib administered orally once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg Baricitinib administered orally once daily.

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg Baricitinib administered orally once daily.

    Arm title
    		 JAGS 4 mg Baricitinib
    Arm description
    		 4 mg Baricitinib administered orally once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg Baricitinib administered orally once daily.

    Arm title
    		 JADA 4 mg Baricitinib
    Arm description
    		 4 mg Baricitinib administered orally once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg Baricitinib administered orally once daily.

    Number of subjects in period 1
    		JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Started
    451
    1090
    180
    403
    117
    331
    221
    83
    Received at Least One Dose of Study Drug
    451
    1090
    180
    403
    117
    331
    221
    83
    Completed
    19
    64
    49
    120
    27
    81
    0
    55
    Not completed
    432
    1026
    131
    283
    90
    250
    221
    28
         Consent withdrawn by subject
    72
    131
    25
    63
    15
    34
    17
    10
         Physician decision
    19
    21
    5
    12
    9
    24
    4
    3
         Adverse event, non-fatal
    52
    136
    30
    73
    17
    72
    24
    5
         Death
    13
    33
    5
    9
    2
    10
    3
    2
         Unknown
    -
    -
    -
    1
    -
    -
    -
    -
         Lost to follow-up
    16
    19
    7
    9
    2
    8
    2
    -
         Sponsor decision
    245
    648
    49
    90
    20
    38
    162
    3
         Lack of efficacy
    12
    33
    10
    23
    24
    58
    9
    5
         Protocol deviation
    3
    5
    -
    3
    1
    6
    -
    -
    Period 2
    Period 2 title
    Step-down
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 2 mg Baricitinib Step-down
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 mg Baricitinib administered orally once daily in the Step-down period.

    Arm title
    		 4 mg Baricitinib Step-down
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg Baricitinib administered orally once daily in the Step-down period.

    Number of subjects in period 2
    		2 mg Baricitinib Step-down 4 mg Baricitinib Step-down
    Started
    592
    594
    Completed
    523
    533
    Not completed
    69
    61
         Consent withdrawn by subject
    25
    15
         Physician decision
    7
    2
         Adverse event, non-fatal
    29
    38
         Death
    4
    3
         Lost to follow-up
    1
    1
         Sponsor decision
    1
    1
         Lack of efficacy
    1
    -
         Protocol deviation
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period Total
    Number of subjects
    		 2876 2876
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2358 2358
        From 65-84 years
    		 517 517
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 2262 2262
        Male
    		 614 614
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 143 143
        Asian
    		 781 781
        Native Hawaiian or Other Pacific Islander
    		 1 1
        Black or African American
    		 64 64
        White
    		 1859 1859
        More than one race
    		 23 23
        Unknown or Not Reported
    		 5 5
    Region of Enrollment
    Units: Subjects
        United States
    		 488 488
        Czechia
    		 56 56
        Portugal
    		 11 11
        Russia
    		 122 122
        Greece
    		 8 8
        South Korea
    		 72 72
        Latvia
    		 8 8
        Sweden
    		 3 3
        Austria
    		 17 17
        Netherlands
    		 1 1
        China
    		 208 208
        Poland
    		 156 156
        Brazil
    		 30 30
        Slovenia
    		 5 5
        Slovakia
    		 27 27
        France
    		 36 36
        Lithuania
    		 21 21
        Croatia
    		 9 9
        Argentina
    		 430 430
        Romania
    		 21 21
        Hungary
    		 60 60
        Japan
    		 328 328
        United Kingdom
    		 26 26
        Switzerland
    		 7 7
        India
    		 71 71
        Spain
    		 86 86
        Canada
    		 47 47
        Turkey
    		 3 3
        Belgium
    		 41 41
        Taiwan
    		 81 81
        Denmark
    		 5 5
        South Africa
    		 56 56
        Italy
    		 27 27
        Mexico
    		 214 214
        Israel
    		 27 27
        Australia
    		 32 32
        Germany
    		 36 36
    Subject analysis sets

    Subject analysis set title
    2 mg Baricitinib
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    2 mg Baricitinib administered orally once daily.

    Subject analysis set title
    4 mg Baricitinib
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    4 mg Baricitinib administered orally once daily.

    Subject analysis sets values
    		 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects
    297
    2579
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    236
    2122
        From 65-84 years
    61
    456
        85 years and over
    0
    1
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    231
    2031
        Male
    66
    548
    Race
    Units: Subjects
        American Indian or Alaska Native
    7
    136
        Asian
    56
    725
        Native Hawaiian or Other Pacific Islander
    0
    1
        Black or African American
    16
    48
        White
    217
    1642
        More than one race
    1
    22
        Unknown or Not Reported
    0
    5
    Region of Enrollment
    Units: Subjects
        United States
    91
    397
        Czechia
    3
    53
        Portugal
    2
    9
        Russia
    10
    112
        Greece
    2
    6
        South Korea
    9
    63
        Latvia
    0
    8
        Sweden
    0
    3
        Austria
    3
    14
        Netherlands
    1
    0
        China
    0
    208
        Poland
    20
    136
        Brazil
    0
    30
        Slovenia
    0
    5
        Slovakia
    3
    24
        France
    6
    30
        Lithuania
    0
    21
        Croatia
    2
    7
        Argentina
    12
    412
        Romania
    2
    19
        Hungary
    8
    52
        Japan
    7
    321
        United Kingdom
    4
    22
        Switzerland
    0
    7
        India
    16
    55
        Spain
    15
    71
        Canada
    11
    36
        Turkey
    1
    2
        Belgium
    3
    38
        Taiwan
    23
    58
        Denmark
    2
    3
        South Africa
    0
    56
        Italy
    6
    21
        Mexico
    13
    201
        Israel
    6
    21
        Australia
    6
    26
        Germany
    4
    32

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    JADZ 4 mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily.

    Reporting group title
    JADV 4 mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily.

    Reporting group title
    JADX 2 mg Baricitinib
    Reporting group description
    		 2 mg Baricitinib administered orally once daily

    Reporting group title
    JADX 4 mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily.

    Reporting group title
    JADW 2 mg Baricitinib
    Reporting group description
    		 2 mg Baricitinib administered orally once daily.

    Reporting group title
    JADW 4 mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily.

    Reporting group title
    JAGS 4 mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily.

    Reporting group title
    JADA 4 mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily.
    Reporting group title
    2 mg Baricitinib Step-down
    Reporting group description
    		 -

    Reporting group title
    4 mg Baricitinib Step-down
    Reporting group description
    		 -

    Subject analysis set title
    2 mg Baricitinib
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    2 mg Baricitinib administered orally once daily.

    Subject analysis set title
    4 mg Baricitinib
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    4 mg Baricitinib administered orally once daily.

    Primary: Number of Participants Who Experienced Adverse Events (AEs) or Serious AE

    		 Close Top of page
    End point title
    		 Number of Participants Who Experienced Adverse Events (AEs) or Serious AE [1]
    End point description
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%. An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
    End point type
    Primary
    End point timeframe
    Baseline through 84 Months Analysis Population Description (APD): All enrolled participants who received at least 1 dose of study drug and did not discontinue the study for the reason 'Lost to Follow-up' at the first postbaseline visit in study JADY.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical comparison was not conducted on safety outcome measure.
    End point values
    		 2 mg Baricitinib Step-down 4 mg Baricitinib Step-down 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    592
    594
    297
    2579
    Units: Count of participants
        Adverse Events
    270
    315
    234
    1532
        Serious Adverse Events
    164
    178
    112
    517
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
    End point description
    ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100 APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 1, 3 and 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of Participants
    number (confidence interval 95%)
        Year 1
    92.6 (89.7 to 94.7)
    88.4 (86.3 to 90.2)
    79.3 (72.6 to 84.7)
    79.5 (75.1 to 83.3)
    72.3 (62.9 to 80.1)
    70.8 (65.2 to 75.9)
    86.7 (81.4 to 90.6)
    75.6 (65.1 to 83.8)
        Year 3
    78.3 (74.1 to 82.0)
    76.6 (73.9 to 79.1)
    71.6 (64.4 to 77.9)
    70.5 (65.6 to 74.9)
    57.4 (47.7 to 66.6)
    55.8 (49.9 to 61.6)
    73.8 (67.5 to 79.3)
    71.8 (61.0 to 80.6)
        Year 5
    67.3 (62.7 to 71.6)
    65.6 (62.6 to 68.4)
    60.4 (52.8 to 67.4)
    56.0 (50.9 to 61.0)
    50.5 (40.9 to 60.0)
    43.1 (37.3 to 49.0)
    24.8 (19.4 to 31.0)
    60.3 (49.2 to 70.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
    End point description
    ACR 50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR50 responders) / (number of participants analyzed) * 100
    End point type
    Secondary
    End point timeframe
    Year 1, 3 and 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    80.0 (75.9 to 83.5)
    67.7 (64.8 to 70.5)
    58.0 (50.5 to 65.2)
    58.2 (53.1 to 63.1)
    45.5 (36.2 to 55.2)
    43.8 (38.0 to 49.7)
    69.0 (62.5 to 74.9)
    43.6 (33.1 to 54.6)
        Year 3
    67.8 (63.2 to 72.1)
    61.6 (58.6 to 64.5)
    49.7 (42.3 to 57.2)
    53.3 (48.2 to 58.3)
    43.6 (34.3 to 53.3)
    36.5 (31.0 to 42.3)
    59.0 (52.3 to 65.5)
    43.6 (33.1 to 54.6)
        Year 5
    59.9 (55.1 to 64.5)
    52.7 (49.7 to 55.7)
    44.4 (37.1 to 51.9)
    43.2 (38.2 to 48.3)
    37.6 (28.8 to 47.4)
    32.1 (26.9 to 37.9)
    18.6 (13.9 to 24.4)
    37.2 (27.3 to 48.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
    End point description
    ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
    End point type
    Secondary
    End point timeframe
    Year 1, 3 and 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    61.3 (56.6 to 65.9)
    45.7 (42.7 to 48.8)
    34.9 (28.1 to 42.4)
    35.8 (31.1 to 40.8)
    28.7 (20.8 to 38.2)
    25.9 (21.1 to 31.4)
    42.9 (36.4 to 49.6)
    26.9 (18.3 to 37.7)
        Year 3
    54.4 (49.6 to 59.1)
    44.1 (41.1 to 47.7)
    35.5 (27.9 to 37.5)
    32.5 (27.9 to 37.5)
    24.8 (17.4 to 34.0)
    21.5 (17.1 to 26.8)
    35.2 (29.1 to 41.9)
    21.8 (14.1 to 32.2)
        Year 5
    48.2 (43.5 to 53.0)
    39.1 (36.1 to 42.1)
    28.4 (22.1 to 35.6)
    28.4 (24.0 to 33.2)
    23.8 (16.5 to 32.9)
    18.2 (14.1 to 23.2)
    12.9 (9.0 to 18.1)
    19.2 (12.0 to 29.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
    End point description
    Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 1, 3 and 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    81.9 (77.9 to 85.3)
    71.9 (69.0 to 74.5)
    66.3 (58.9 to 73.0)
    68.6 (63.7 to 73.1)
    50.5 (40.9 to 60.0)
    51.1 (45.2 to 57.0)
    72.4 (66.0 to 78.0)
    59.0 (47.9 to 69.2)
        Year 3
    71.8 (67.3 to 75.9)
    65.5 (62.5 to 68.3)
    59.2 (51.6 to 66.3)
    59.3 (54.2 to 64.2)
    47.5 (38.1 to 57.2)
    41.6 (35.9 to 47.5)
    61.0 (54.2 to 67.3)
    60.3 (49.2 to 70.4)
        Year 5
    61.1 (56.3 to 65.6)
    58.9 (55.9 to 61.9)
    46.7 (39.4 to 54.3)
    50.0 (44.9 to 55.1)
    44.6 (35.2 to 54.3)
    34.3 (28.9 to 40.1)
    21.0 (16.0 to 27.0)
    53.8 (42.9 to 64.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) <2.6

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) <2.6
    End point description
    DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 1, 3 and 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    65.6 (61.0 to 70.0)
    52.3 (49.3 to 55.4)
    50.9 (43.4 to 58.3)
    46.2 (41.1 to 51.3)
    34.7 (26.1 to 44.3)
    32.8 (27.6 to 38.6)
    52.4 (45.6 to 59.0)
    44.9 (34.3 to 55.9)
        Year 3
    59.9 (55.1 to 64.5)
    51.0 (47.9 to 54.0)
    43.8 (36.5 to 51.3)
    43.2 (38.2 to 48.3)
    31.7 (23.4 to 41.3)
    26.3 (21.4 to 31.8)
    38.6 (32.2 to 45.3)
    35.9 (26.1 to 47.0)
        Year 5
    51.1 (46.3 to 55.8)
    44.0 (41.0 to 47.0)
    36.1 (29.2 to 43.6)
    37.7 (32.9 to 42.8)
    29.7 (21.7 to 39.2)
    26.6 (21.8 to 32.2)
    13.3 (9.4 to 18.6)
    43.6 (33.1 to 54.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
    End point description
    Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
    End point type
    Secondary
    End point timeframe
    Year 1, 3, and 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    30.5 (26.3 to 35.1)
    20.8 (18.4 to 23.4)
    17.8 (12.7 to 24.2)
    17.8 (14.2 to 22.0)
    8.9 (4.8 to 16.1)
    9.5 (6.6 to 13.5)
    17.1 (12.6 to 22.8)
    12.8 (7.1 to 22.0)
        Year 3
    30.8 (26.6 to 35.4)
    20.3 (18.0 to 22.9)
    16.6 (11.7 to 22.9)
    15.0 (11.7 to 19.1)
    9.9 (5.5 to 17.3)
    8.0 (5.4 to 11.9)
    11.9 (8.2 to 17.0)
    15.4 (9.0 to 25.0)
        Year 5
    26.5 (22.5 to 30.9)
    17.7 (15.5 to 20.1)
    13.6 (9.2 to 19.6)
    14.2 (11.0 to 18.2)
    6.9 (3.4 to 13.6)
    7.3 (4.8 to 11.0)
    5.2 (2.9 to 9.1)
    15.4 (9.0 to 25.0)
    No statistical analyses for this end point

    Secondary: Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)

    		 Close Top of page
    End point title
    		 Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
    End point description
    X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. APD: All enrolled participants who received at least 1 dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 1 data. Year 1 data not available, 0 participants analyzed. JADW and JADA, 0 participants analyzed due to no data collected in this study
    End point type
    Secondary
    End point timeframe
    Baseline, Year 1, Baseline, Year 3; Baseline, Year 5 N represents treatments arms consecutively which corresponds with listings in the header.
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    387 [2]
    870 [3]
    137 [4]
    301 [5]
    0 [6]
    0 [7]
    203 [8]
    0 [9]
    Units: Score on a scale
    least squares mean (confidence interval 95%)
        Year 1: N=0, N=0, N=0, N=0, N=0, N=0, N=0, N=0
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    ( to )
    ( to )
    9999 (9999 to 9999)
    ( to )
        Year 3:N=387,N=943,N=137,N=301,N=0,N=0,N=203,N=0
    1.03 (0.94 to 1.67)
    1.64 (1.38 to 1.90)
    1.13 (0.61 to 1.66)
    1.13 (0.78 to 1.48)
    ( to )
    ( to )
    1.20 (0.61 to 1.80)
    ( to )
        Year 5:N=349,N=870,N=127,N=276,N=0,N=0,N=0,N=0
    1.64 (1.18 to 2.09)
    2.18 (1.85 to 2.51)
    1.32 (0.69 to 1.96)
    1.58 (1.15 to 2.02)
    ( to )
    ( to )
    9999 (9999 to 9999)
    ( to )
    Notes
    [2] - 9999=Data not available, zero participants analyzed.
    [3] - 9999=Data not available, zero participants analyzed.
    [4] - 9999=Data not available, zero participants analyzed.
    [5] - 9999=Data not available, zero participants analyzed.
    [6] - Zero participants analyzed due to no data collected in this study or originating study.
    [7] - Zero participants analyzed due to no data collected in this study or originating study.
    [8] - 9999 = Data not available, zero participants analyzed.
    [9] - Zero participants analyzed due to no data collected in this study or originating study.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With mTSS Change ≤0

    		 Close Top of page
    End point title
    		 Percentage of Participants With mTSS Change ≤0
    End point description
    X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage. APD: All enrolled participants who received at least one dose of study drug. and completed at least 48 weeks in study JADY. Year 1 data not available, zero participants analyzed due to no data collected in this study or originating study.
    End point type
    Secondary
    End point timeframe
    Year 1, 3, and 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419 [10]
    1034 [11]
    169 [12]
    366 [13]
    0 [14]
    0 [15]
    210 [16]
    0 [17]
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    ( to )
    ( to )
    9999 (9999 to 9999)
    ( to )
        Year 3
    53.5 (48.7 to 58.2)
    53.0 (50.0 to 56.0)
    0.6 (0.1 to 3.3)
    0.8 (0.3 to 2.4)
    ( to )
    ( to )
    0.0 (0.0 to 1.8)
    ( to )
        Year 5
    1.7 (0.8 to 3.4)
    0.6 (0.3 to 1.3)
    0.0 (0.0 to 2.2)
    0.5 (0.1 to 2.0)
    ( to )
    ( to )
    0.0 (0.0 to 1.8)
    ( to )
    Notes
    [10] - 9999 = Data not available, zero participants analyzed
    [11] - 9999 = Data not available, zero participants analyzed
    [12] - 9999 = Data not available, zero participants analyzed
    [13] - 9999 = Data not available, zero participants analyzed
    [14] - No data collected; zero participants analyzed.
    [15] - No data collected; zero participants analyzed.
    [16] - 9999 = Data not available, zero participants analyzed
    [17] - No data collected; zero participants analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline of Originating Study in Joint Space Narrowing

    		 Close Top of page
    End point title
    		 Change From Baseline of Originating Study in Joint Space Narrowing
    End point description
    X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. APD: All enrolled participants treated with at least 1 dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.
    End point type
    Secondary
    End point timeframe
    Baseline, Year 3; Baseline, Year 5 N represents treatments arms consecutively which corresponds with listings in the header.
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    387 [18]
    943 [19]
    137 [20]
    301 [21]
    0 [22]
    0 [23]
    203 [24]
    0 [25]
    Units: Score on a scale
    least squares mean (confidence interval 95%)
        Year 1: N=0, N=0, N=0, N=0, N=0, N=0, N=0, N=0
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    ( to )
    ( to )
    9999 (9999 to 9999)
    ( to )
        Year 3:N=387,N=943,N=137,N=301,N=0,N=0,N= 203,N=0
    0.45 (0.26 to 0.63)
    0.72 (0.59 to 0.86)
    0.54 (0.25 to 0.83)
    0.44 (0.24 to 0.63)
    ( to )
    ( to )
    0.52 (0.23 to 0.82)
    ( to )
        Year 5:N=349, N-870,N=127,N=276, N=0, N=0, N=0,N=0
    0.59 (0.36 to 0.83)
    1.00 (0.84 to 1.17)
    0.68 (0.34 to 1.02)
    0.60 (0.37 to 0.83)
    ( to )
    ( to )
    9999 (9999 to 9999)
    ( to )
    Notes
    [18] - No data collected; zero participants analyzed.
    [19] - No data collected; zero participants analyzed.
    [20] - No data collected; zero participants analyzed.
    [21] - No data collected; zero participants analyzed.
    [22] - No data collected; zero participants analyzed.
    [23] - No data collected; zero participants analyzed.
    [24] - JAGS, JADW, and JADA: no data collected in this study or originating study, 0 participants analyzed.
    [25] - No data collected; zero participants analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline of Originating Study in Duration of Morning Stiffness

    		 Close Top of page
    End point title
    		 Change From Baseline of Originating Study in Duration of Morning Stiffness
    End point description
    Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition. APD: All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. There were no baseline data for JADX
    End point type
    Secondary
    End point timeframe
    Baseline, Year1 ; Baseline, Year 3; Baseline, Year 5 N represents treatments arms consecutively which corresponds with listings in the header.
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    450
    633
    0 [26]
    0 [27]
    110
    308
    221
    78
    Units: Minutes
    arithmetic mean (standard deviation)
        Yr 1:N=450,N-633,N=0,N=0,N=110,N=308,N=221,N=78
    -102.72 ( 155.27 )
    -73.53 ( 144.22 )
    ( )
    ( )
    -75.07 ( 139.00 )
    73.88 ( 149.55 )
    -68.74 ( 148.34 )
    -37.12 ( 61.34 )
        Yr 3:N=387,N=556,N=0,N=0,N=81,N=222,N=192,N-69
    -112.41 ( 159.78 )
    -77.78 ( 141.01 )
    ( )
    ( )
    -84.60 ( 127.80 )
    -67.79 ( 154.05 )
    -90.61 ( 147.70 )
    -47.13 ( 52.97 )
        Yr 5:N=330,N=470,N=0,N=0,N=70,N-169,N=128,N=57
    -111.45 ( 164.74 )
    -82.48 ( 137.23 )
    ( )
    ( )
    88.37 ( 146.73 )
    -91.57 ( 163.88 )
    -92.75 ( 125.39 )
    -45.89 ( 60.43 )
    Notes
    [26] - No data collected; zero participants analyzed.
    [27] - No data collected; zero participants analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores (UK)

    		 Close Top of page
    End point title
    		 Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores (UK)
    End point description
    The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. APD: All enrolled participants who received at least 1 dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Year 1; Baseline, Year 3; Baseline, Year 5
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    450
    1088
    171
    383
    108
    305
    221
    0 [28]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Yr1:N=450,N=1088,N=171,N=383,N=108,N=305,N=221,N=0
    0.28 ( 0.26 )
    0.23 ( 0.24 )
    0.19 ( 0.26 )
    0.20 ( 0.23 )
    0.21 ( 0.22 )
    0.19 ( 0.24 )
    0.20 ( 0.26 )
    ( )
        Yr3:N=386,N=952,N=146,N=309,N=80,N=219,N=190,N=0
    0.33 ( 0.24 )
    0.24 ( 0.25 )
    0.20 ( 0.26 )
    0.21 ( 0.26 )
    0.21 ( 0.22 )
    0.22 ( 0.25 )
    0.24 ( 0.24 )
    ( )
        Yr5:N=330,N=820,N=122,N=264,N=70,N=169,N=127,N=0
    0.35 ( 0.24 )
    0.26 ( 0.26 )
    0.19 ( 0.25 )
    0.20 ( 0.26 )
    0.21 ( 0.22 )
    0.22 ( 0.30 )
    0.25 ( 0.26 )
    ( )
    Notes
    [28] - Zero participants analyzed; data not collected.
    No statistical analyses for this end point

    Secondary: Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Halth State Scores (US)

    		 Close Top of page
    End point title
    		 Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Halth State Scores (US)
    End point description
    The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. APD: All enrolled participants who received at least 1 dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Year 1; Baseline Year 3; Baseline, Year 5 N represents treatments arms consecutively which corresponds with listings in the header.
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    450
    1088
    171
    383
    108
    305
    221
    0 [29]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Yr1:N=450,N=1088,N=171,N=383,N=108,N=305,N=221,N=0
    0.19 ( 0.18 )
    0.16 ( 0.17 )
    0.13 ( 0.18 )
    0.14 ( 0.16 )
    0.14 ( 0.15 )
    0.13 ( 0.16 )
    0.14 ( 0.18 )
    ( )
        Yr3:N=386,N=952,N=146,N=309,N=80,N=219,N=190,N=0
    0.23 ( 0.17 )
    0.17 ( 0.17 )
    0.15 ( 0.18 )
    0.15 ( 0.18 )
    0.14 ( 0.15 )
    0.15 ( 0.17 )
    0.17 ( 0.17 )
    ( )
        Yr5:N=330,N=820,N=122,N=264,N=70,N=169,N=127,N=0
    0.24 ( 0.16 )
    0.18 ( 0.18 )
    0.13 ( 0.17 )
    0.14 ( 0.18 )
    0.15 ( 0.15 )
    0.15 ( 0.20 )
    0.18 ( 0.18 )
    ( )
    Notes
    [29] - Zero participants analyzed; data not collected.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
    End point description
    The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 3 and Year 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    81.6 (77.6 to 85.0)
    75.3 (72.6 to 77.9)
    68.6 (61.3 to 75.2)
    69.9 (65.1 to 74.4)
    52.5 (42.8 to 61.9)
    50.7 (44.8 to 56.6)
    73.3 (67.0 to 78.9)
    60.3 (49.2 to 70.4)
        Year 3
    73.3 (68.8 to 77.3)
    67.7 (64.8 to 70.5)
    60.4 (52.8 to 67.4)
    60.4 (55.3 to 65.3)
    49.5 (40.0 to 59.1)
    44.5 (38.8 to 50.4)
    61.4 (54.7 to 67.8)
    56.4 (45.4 to 66.9)
        Year 5
    61.6 (56.8 to 66.1)
    61.1 (58.1 to 64.0)
    51.5 (44.0 to 58.9)
    54.6 (49.5 to 59.7)
    44.6 (35.2 to 54.3)
    35.4 (30.0 to 41.2)
    21.9 (16.8 to 28.0)
    56.4 (45.4 to 66.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
    End point description
    The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 3 and Year 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    44.9 (40.2 to 49.7)
    28.3 (25.7 to 31.2)
    21.9 (16.3 to 28.7)
    25.1 (21.0 to 29.8)
    16.8 (10.8 to 25.3)
    13.5 (10.0 to 18.1)
    22.9 (17.7 to 29.0)
    14.1 (8.1 to 23.5)
        Year 3
    40.1 (35.5 to 44.9)
    30.0 (27.3 to 32.8)
    21.9 (16.3 to 28.7)
    23.5 (19.4 to 28.1)
    22.8 (15.7 to 31.9)
    15.0 (11.2 to 19.7)
    18.6 (13.9 to 24.4)
    20.5 (13.0 to 30.8)
        Year 5
    33.9 (29.5 to 38.6)
    25.0 (22.5 to 27.8)
    19.5 (14.3 to 26.2)
    22.4 (18.4 to 27.0)
    15.8 (10.0 to 24.2)
    12.8 (9.3 to 17.2)
    8.1 (5.1 to 12.6)
    19.2 (12.0 to 29.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
    End point description
    The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 3 and Year 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    89.7 (86.5 to 92.3)
    81.4 (78.9 to 83.7)
    78.7 (71.9 to 84.2)
    75.4 (70.7 to 79.5)
    74.3 (65.0 to 81.8)
    69.3 (63.6 to 74.5)
    80.0 (74.1 to 84.8)
    48.7 (37.9 to 59.6)
        Year 3
    75.4 (71.1 to 79.3)
    70.4 (67.6 to 73.1)
    64.5 (57.0 to 71.3)
    63.4 (58.3 to 68.2)
    56.4 (46.7 to 65.7)
    54.4 (48.5 to 60.2)
    68.1 (61.5 to 74.0)
    47.4 (36.7 to 58.4)
        Year 5
    65.2 (60.5 to 69.6)
    58.5 (55.5 to 61.5)
    51.5 (44.0 to 58.9)
    51.4 (46.3 to 56.4)
    50.5 (40.9 to 60.0)
    39.4 (33.8 to 45.3)
    20.0 (15.2 to 25.9)
    39.7 (29.6 to 50.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
    End point description
    The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 3 and Year 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    85.4 (81.7 to 88.5)
    75.6 (72.9 to 78.1)
    72.8 (65.6 to 78.9)
    69.4 (64.5 to 73.9)
    65.3 (55.7 to 73.9)
    61.7 (55.8 to 67.2)
    75.2 (69.0 to 80.6)
    43.6 (33.1 to 54.6)
        Year 3
    72.6 (68.1 to 76.6)
    64.8 (61.8 to 67.6)
    61.5 (54.0 to 68.5)
    58.5 (53.4 to 63.4)
    50.5 (40.9 to 60.0)
    47.8 (42.0 to 53.7)
    63.8 (57.1 to 70.0)
    38.5 (28.4 to 49.6)
        Year 5
    62.8 (58.0 to 67.3)
    53.4 (50.3 to 56.4)
    46.7 (39.4 to 54.3)
    46.2 (41.1 to 51.3)
    46.5 (37.1 to 56.2)
    35.0 (29.6 to 40.9)
    19.5 (14.7 to 25.4)
    34.6 (25.0 to 45.7)
    No statistical analyses for this end point

    Secondary: Change From Baseline of Originating Study in Bone Erosion Score

    		 Close Top of page
    End point title
    		 Change From Baseline of Originating Study in Bone Erosion Score
    End point description
    The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion. LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors. APD: All enrolled participants treated with at least 1 dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY).
    End point type
    Secondary
    End point timeframe
    Baseline, Year 1; Baseline, Year 3; Baseline, Year 5 N represents treatments arms consecutively which corresponds with listings in the header. APD: JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    387 [30]
    943 [31]
    137 [32]
    301 [33]
    0 [34]
    0 [35]
    203 [36]
    0 [37]
    Units: Score on a sclae
    least squares mean (confidence interval 95%)
        Year 1: N=0, N=0, N=0, N=0, N=0, N=0, N=0, N=0
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    ( to )
    ( to )
    9999 (9999 to 9999)
    ( to )
        Year 3: N=387,N=943,N=137,N=301,N=0,N=0,N=203,N=0
    0.85 (0.63 to 1.08)
    0.92 (0.76 to 1.07)
    0.59 (0.30 to 0.89)
    0.69 (0.49 to 0.89)
    ( to )
    ( to )
    0.68 (0.32 to 1.03)
    ( to )
        Year 5: N=349,N=870,N=127,N=276,N=0,N=0,N=0,N=0
    1.04 (0.77 to 1.32)
    1.18 (0.98 to 1.38)
    0.65 (0.28 to 1.01)
    0.98 (0.74 to 1.23)
    ( to )
    ( to )
    9999 (9999 to 9999)
    ( to )
    Notes
    [30] - 9999 = Data not available, zero participants analyzed.
    [31] - 9999 = Data not available, zero participants analyzed.
    [32] - 9999 = Data not available, zero participants analyzed.
    [33] - 9999 = Data not available, zero participants analyzed.
    [34] - No data collected; zero participants analyzed.
    [35] - No data collected; zero participants analyzed.
    [36] - 9999 = Data not available, zero participants analyzed.
    [37] - No data collected; zero participants analyzed.
    No statistical analyses for this end point

    Secondary: Healthcare Resource Utilization

    		 Close Top of page
    End point title
    		 Healthcare Resource Utilization
    End point description
    Healthcare resource utilization data will be collected by site staff regarding the number of visits to medical care providers such as general practitioners, specialists, physical or occupational therapists, and other nonphysical care providers for services outside of the clinical study; emergency room admissions; hospital admissions; and concomitant medications related to the treatment of Rheumatoid Arthritis (RA). APD: All enrolled participants who received at least one dose of study drug, with access healthcare services outside of the clinical study.
    End point type
    Secondary
    End point timeframe
    Baseline Up to 84 months
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    451
    1090
    180
    403
    117
    331
    221
    83
    Units: Consultations
    number (not applicable)
        Healthcare Consultations
    3134
    11108
    2160
    4573
    2380
    5410
    717
    749
        Emergency Room Consultations
    95
    244
    52
    131
    73
    154
    40
    16
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
    End point description
    SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 1, Year 3, and Year 5 after entry in to JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    81.6 (77.6 to 85.0)
    75.2 (72.5 to 77.8)
    70.4 (63.1 to 76.8)
    69.1 (64.2 to 73.6)
    53.5 (43.8 to 62.9)
    53.6 (47.7 to 59.5)
    72.4 (66.0 to 78.0)
    59.0 (47.9 to 69.2)
        Year 3
    73.3 (68.8 to 77.3)
    67.8 (64.9 to 70.6)
    60.9 (53.4 to 68.0)
    62.3 (57.2 to 67.1)
    48.5 (39.0 to 58.1)
    44.5 (38.8 to 50.4)
    60.0 (53.3 to 66.4)
    57.7 (46.6 to 68.0)
        Year 5
    61.3 (56.6 to 65.9)
    61.2 (58.2 to 64.1)
    51.5 (44.0 to 58.9)
    53.3 (48.2 to 58.3)
    46.5 (37.1 to 56.2)
    35.4 (30.0 to 41.2)
    23.3 (18.1 to 29.5)
    57.7 (46.6 to 68.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
    End point description
    SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 1, Year 3 and Year 5
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    45.3 (40.6 to 50.1)
    28.9 (26.2 to 31.8)
    24.3 (18.4 to 31.2)
    23.5 (19.4 to 28.1)
    13.9 (8.4 to 21.9)
    13.1 (9.6 to 17.7)
    22.9 (17.7 to 29.0)
    14.1 (8.1 to 23.5)
        Year 3
    39.9 (35.3 to 44.6)
    29.8 (27.1 to 32.6)
    22.5 (16.8 to 29.4)
    21.6 (17.7 to 26.1)
    19.8 (13.2 to 28.6)
    13.5 (10.0 to 18.1)
    15.7 (11.4 to 21.2)
    21.8 (14.1 to 32.2)
        Year 5
    34.8 (30.4 to 39.5)
    24.7 (22.1 to 27.4)
    20.7 (15.3 to 27.4)
    21.3 (17.4 to 25.8)
    13.9 (8.4 to 21.9)
    11.3 (8.1 to 15.6)
    8.1 (5.1 to 12.6)
    21.8 (14.1 to 32.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Relapse Event During the 96-Week Step-Down Period

    		 Close Top of page
    End point title
    		 Percentage of Participants with Relapse Event During the 96-Week Step-Down Period
    End point description
    Relapse is defined as a Clinical Disease Activity Index score > 10. The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. Total number of participants at risk multiplied by estimate of cumulative event probability would need to be rounded up or down to get a whole number.
    End point type
    Secondary
    End point timeframe
    Week 0 through Week 96 of Step-down APD: All enrolled participants who were randomized, were not rescued, and received at least one dose of study drug during the step-down period.
    End point values
    		 2 mg Baricitinib Step-down 4 mg Baricitinib Step-down
    Number of subjects analysed
    498
    498
    Units: Percentage of participants
    number (not applicable)
        Week 12
    11.8
    5.4
        Week 24
    26.0
    12.5
        Week 36
    31.0
    18.2
        Week 48
    36.0
    21.1
        Week 60
    41.0
    26.6
        Week 72
    45.1
    29.1
        Week 84
    46.7
    31.0
        Week 96
    47.8
    34.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
    End point description
    DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 1, 3, and 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    274
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    61.8 (57.1 to 66.3)
    48.4 (45.3 to 51.4)
    46.2 (38.8 to 53.7)
    48.4 (43.3 to 53.5)
    31.7 (23.4 to 41.3)
    31.8 (26.5 to 37.5)
    41.0 (34.5 to 47.7)
    35.9 (26.1 to 47.0)
        Year 3
    54.4 (49.6 to 59.1)
    46.1 (43.1 to 49.2)
    40.2 (33.1 to 47.8)
    41.0 (36.1 to 46.1)
    22.8 (15.7 to 31.9)
    23.7 (19.1 to 29.1)
    33.8 (27.8 to 40.4)
    37.2 (27.3 to 48.3)
        Year 5
    48.7 (43.9 to 53.5)
    41.3 (38.3 to 44.3)
    36.1 (29.2 to 43.6)
    32.5 (27.9 to 37.5)
    23.8 (16.5 to 32.9)
    21.9 (17.4 to 27.2)
    11.4 (7.8 to 16.4)
    37.2 (27.3 to 48.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
    End point description
    DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. APD: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
    End point type
    Secondary
    End point timeframe
    Year 1, 3, and 5 after entry into JADY
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    419
    1034
    169
    366
    101
    241
    210
    78
    Units: Percentage of participants
    number (confidence interval 95%)
        Year 1
    36.8 (32.3 to 41.5)
    29.3 (26.6 to 32.2)
    24.3 (18.4 to 31.2)
    26.8 (22.5 to 31.5)
    20.8 (14.0 to 29.7)
    13.1 (9.6 to 17.7)
    25.2 (19.8 to 31.5)
    15.4 (9.0 to 25.0)
        Year 3
    38.9 (34.4 to 43.7)
    24.7 (22.1 to 27.4)
    24.3 (18.4 to 31.2)
    23.2 (19.2 to 27.8)
    15.8 (10.0 to 24.2)
    10.2 (7.2 to 14.4)
    19.5 (14.7 to 25.4)
    23.1 (15.1 to 33.6)
        Year 5
    31.3 (27.0 to 35.9)
    23.9 (21.4 to 26.6)
    22.5 (16.8 to 29.4)
    19.4 (15.7 to 23.8)
    11.9 (6.9 to 19.6)
    8.8 (6.0 to 12.7)
    7.1 (4.4 to 11.4)
    19.2 (12.0 to 29.3)
    No statistical analyses for this end point

    Secondary: Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)

    		 Close Top of page
    End point title
    		 Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
    End point description
    The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. APD: All enrolled participants who received at least 1 dose of study drug and completed at least 48 weeks in study JADY. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Year 1; Baseline, Year 3; Baseline, Year 5
    End point values
    		 JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
    Number of subjects analysed
    450
    1088
    171
    383
    108
    305
    221
    0 [38]
    Units: millimeter(s)
    arithmetic mean (standard deviation)
        Yr1:N=450,N=1088,N=171,N=383,N=108,N=305,N=221,N=0
    24.69 ( 28.50 )
    19.72 ( 28.17 )
    15.13 ( 26.78 )
    18.32 ( 26.35 )
    20.96 ( 24.53 )
    14.98 ( 30.21 )
    18.47 ( 27.31 )
    ( )
        Yr3:N=386,N=952,N=146,N=309,N=80,N=219,N=190,N=0
    28.48 ( 29.88 )
    22.10 ( 28.02 )
    16.29 ( 25.37 )
    16.48 ( 30.24 )
    23.53 ( 24.70 )
    18.79 ( 30.03 )
    21.45 ( 29.64 )
    ( )
        Yr5:N=330,N=820,N=122,N=264,N=70,N=169,N=127,N=0
    31.13 ( 28.15 )
    23.93 ( 28.45 )
    13.82 ( 25.59 )
    19.34 ( 27.48 )
    26.19 ( 27.09 )
    23.57 ( 31.67 )
    27.31 ( 27.19 )
    ( )
    Notes
    [38] - Zero participants analyzed; data not collected.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 84 months.
    Adverse event reporting additional description
    All enrolled participants who received at least 1 dose of study drug and did not discontinue the study for the reason 'Lost to Follow-up' at the first postbaseline visit in study JADY. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    2 mg Baricitinib
    Reporting group description
    		 2 mg Baricitinib administered orally once daily throughout the 84-month treatment period.

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily throughout the 84-month treatment period.

    Reporting group title
    2 mg Baricitinib Step-Down
    Reporting group description
    		 2 mg Baricitinib administered orally once daily throughout the 96-week step-down period.

    Reporting group title
    4 mg Baricitinib Step-Down
    Reporting group description
    		 4 mg Baricitinib administered orally once daily throughout the 96-week step-down period.

    Serious adverse events
    		 2 mg Baricitinib 4 mg Baricitinib 2 mg Baricitinib Step-Down 4 mg Baricitinib Step-Down
    Total subjects affected by serious adverse events
         subjects affected / exposed
    112 / 297 (37.71%)
    517 / 2579 (20.05%)
    164 / 592 (27.70%)
    178 / 594 (29.97%)
         number of deaths (all causes)
    7
    43
    14
    14
         number of deaths resulting from adverse events
    1
    11
    4
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    adenocarcinoma of colon
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    adenocarcinoma pancreas
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    anaplastic meningioma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    angiolipoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    basal cell carcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    benign neoplasm of skin
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    benign neoplasm of thyroid gland
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bladder cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    2 / 592 (0.34%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bowen's disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    brain neoplasm
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    breast cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    breast cancer metastatic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    cervix carcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [1]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    1 / 440 (0.23%)
    0 / 448 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cervix carcinoma stage 0
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [2]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    clear cell renal cell carcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colon adenoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colon cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colorectal cancer stage iv
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diffuse large b-cell lymphoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    extranodal marginal zone b-cell lymphoma (malt type)
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fibrous histiocytoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gallbladder cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    gastric cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastric neoplasm
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    giant cell tumour of tendon sheath
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intraductal proliferative breast lesion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    invasive ductal breast carcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    4 / 2579 (0.16%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 4
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    large granular lymphocytosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    laryngeal cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    large intestine fibroma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lentigo maligna
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    leukaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lipoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung adenocarcinoma stage iv
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung adenocarcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    lung cancer metastatic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung neoplasm
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung neoplasm malignant
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    1 / 2
    0 / 0
    lung squamous cell carcinoma metastatic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    lymphocytic leukaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lymphoproliferative disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    2 / 592 (0.34%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant fibrous histiocytoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant glioma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant melanoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    malignant melanoma in situ
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant peritoneal neoplasm
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant pleural effusion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meningioma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metastases to central nervous system
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metastases to peritoneum
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metastatic gastric cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    mucoepidermoid carcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mueller's mixed tumour
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [3]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    neoplasm malignant
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    neuroendocrine carcinoma of the skin
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    non-hodgkin's lymphoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    non-small cell lung cancer metastatic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    nonkeratinising carcinoma of nasopharynx
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    oesophageal squamous cell carcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oral neoplasm benign
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ovarian adenoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [4]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ovarian cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [5]
    1 / 231 (0.43%)
    2 / 2031 (0.10%)
    0 / 440 (0.00%)
    1 / 448 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ovarian cancer stage iv
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [6]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ovarian germ cell teratoma benign
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [7]
    1 / 231 (0.43%)
    0 / 2031 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    paget's disease of nipple
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatic carcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    pancreatic carcinoma metastatic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatic carcinoma stage iv
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    papillary cystadenoma lymphomatosum
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    papillary thyroid cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    prostate cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [8]
    1 / 66 (1.52%)
    3 / 548 (0.55%)
    2 / 152 (1.32%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    prostate cancer metastatic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [9]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 152 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    prostatic adenoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [10]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 152 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rectal cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal cell carcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    skin cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    small cell lung cancer metastatic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma of lung
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma of the cervix
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [11]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma of the parotid gland
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    t-cell lymphoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thyroid cancer stage i
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    uterine carcinoma in situ
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [12]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 440 (0.23%)
    0 / 448 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    uterine cancer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [13]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 440 (0.23%)
    0 / 448 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    uterine leiomyoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [14]
    0 / 231 (0.00%)
    2 / 2031 (0.10%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    aortic arteriosclerosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    deep vein thrombosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    4 / 297 (1.35%)
    14 / 2579 (0.54%)
    2 / 592 (0.34%)
    4 / 594 (0.67%)
         occurrences causally related to treatment / all
    0 / 4
    5 / 16
    2 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    embolism arterial
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    essential hypertension
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haematoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypertensive crisis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypertension
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypovolaemic shock
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    intermittent claudication
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    jugular vein thrombosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    necrosis ischaemic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral artery stenosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral ischaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral venous disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rheumatoid vasculitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thrombophlebitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thrombosed varicose vein
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    varicose vein
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vasculitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    venous thrombosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    venous thrombosis limb
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    arthrodesis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cataract operation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    finger amputation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hysterectomy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [15]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 440 (0.23%)
    0 / 448 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    internal fixation of fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint arthroplasty
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    knee arthroplasty
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    limb reconstructive surgery
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rehabilitation therapy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    scar excision
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    shoulder arthroplasty
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vaginal cyst excision
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [16]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    abortion spontaneous
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [17]
    1 / 231 (0.43%)
    2 / 2031 (0.10%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pregnancy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [18]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    1 / 440 (0.23%)
    0 / 448 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    adverse drug reaction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    alcohol interaction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chest pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    complication associated with device
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    death
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    exercise tolerance decreased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    general physical health deterioration
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mucosal inflammation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    multiple organ dysfunction syndrome
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sudden cardiac death
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    systemic inflammatory response syndrome
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    anaphylactic reaction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypersensitivity
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    respite care
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    adnexa uteri cyst
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [19]
    0 / 231 (0.00%)
    2 / 2031 (0.10%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bartholin's cyst
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [20]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 440 (0.00%)
    1 / 448 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [21]
    0 / 66 (0.00%)
    1 / 548 (0.18%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cervical cyst
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [22]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cervical dysplasia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [23]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    2 / 440 (0.45%)
    1 / 448 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dysfunctional uterine bleeding
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [24]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 440 (0.00%)
    1 / 448 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endometrial hyperplasia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [25]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endometrial hypertrophy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [26]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 440 (0.00%)
    1 / 448 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endometriosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [27]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    2 / 440 (0.45%)
    0 / 448 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    genital prolapse
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metrorrhagia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [28]
    0 / 231 (0.00%)
    4 / 2031 (0.20%)
    0 / 440 (0.00%)
    1 / 448 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ovarian cyst
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [29]
    0 / 231 (0.00%)
    3 / 2031 (0.15%)
    0 / 440 (0.00%)
    1 / 448 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pelvic pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    testicular cyst
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [30]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 152 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    uterine polyp
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [31]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 440 (0.00%)
    1 / 448 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    uterine prolapse
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [32]
    1 / 231 (0.43%)
    0 / 2031 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [33]
    1 / 231 (0.43%)
    0 / 2031 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vaginal prolapse
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [34]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute pulmonary oedema
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    acute respiratory distress syndrome
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    acute respiratory failure
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    5 / 2579 (0.19%)
    0 / 592 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 2
    allergic bronchitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    asthma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atelectasis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bronchitis chronic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bronchopneumopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bronchospasm
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    9 / 2579 (0.35%)
    2 / 592 (0.34%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 17
    0 / 11
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    cough
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    interstitial lung disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    5 / 2579 (0.19%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 6
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    lung disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nasal polyps
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    obstructive airways disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    organising pneumonia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pleurisy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia aspiration
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    pneumonitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary arterial hypertension
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    5 / 297 (1.68%)
    18 / 2579 (0.70%)
    5 / 592 (0.84%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    4 / 8
    6 / 21
    1 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    0 / 2
    0 / 0
    pulmonary hypertension
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary mass
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary oedema
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    6 / 2579 (0.23%)
    0 / 592 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 7
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    respiratory arrest
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vocal cord polyp
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    confusional state
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    depressed mood
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    depression
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mental disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    device dislocation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    device failure
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    device loosening
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    bile duct stone
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    biliary colic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    biliary obstruction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholangitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholecystitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    4 / 2579 (0.16%)
    3 / 592 (0.51%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 5
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholecystitis chronic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholecystitis acute
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    8 / 2579 (0.31%)
    1 / 592 (0.17%)
    10 / 594 (1.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 9
    0 / 1
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gallbladder polyp
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hepatic cirrhosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    liver disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nonalcoholic fatty liver disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    blood glucose increased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    blood pressure increased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac murmur
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    electrocardiogram t wave inversion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    electrocardiogram change
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    glomerular filtration rate decreased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemoglobin decreased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    influenza a virus test positive
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mycobacterium tuberculosis complex test positive
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transaminases increased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    accident
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ankle fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    brain herniation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    burns second degree
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    carbon monoxide poisoning
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cervical vertebral fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colon injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    compression fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    contusion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    crush injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dislocation of vertebra
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    epiphyseal injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    face injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    13 / 2579 (0.50%)
    1 / 592 (0.17%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 14
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femoral neck fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    7 / 2579 (0.27%)
    3 / 592 (0.51%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 8
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fibula fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    foot fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hand fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    head injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    5 / 2579 (0.19%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    humerus fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    1 / 592 (0.17%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint dislocation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    2 / 592 (0.34%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    keratorhexis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ligament rupture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lower limb fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lumbar vertebral fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meniscus injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    7 / 2579 (0.27%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    open globe injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    open fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    overdose
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    patella fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pelvic fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    periprosthetic fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    post procedural haematoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    post procedural complication
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    post procedural haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    radius fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    scapula fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    seroma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    skin wound
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    skull fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal compression fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    6 / 2579 (0.23%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suture rupture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    synovial rupture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tendon injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tendon rupture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    2 / 592 (0.34%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thoracic vertebral fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    1 / 592 (0.17%)
    4 / 594 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    toxicity to various agents
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    traumatic arthritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    upper limb fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound dehiscence
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wrist fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    congenital central nervous system anomaly
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hydrocele
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [35]
    0 / 66 (0.00%)
    1 / 548 (0.18%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypertrophic cardiomyopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute coronary syndrome
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    acute left ventricular failure
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    acute myocardial infarction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    4 / 297 (1.35%)
    7 / 2579 (0.27%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 7
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    angina pectoris
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    angina unstable
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    5 / 2579 (0.19%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    aortic valve disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    aortic valve incompetence
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    aortic valve stenosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    arteriosclerosis coronary artery
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    4 / 297 (1.35%)
    11 / 2579 (0.43%)
    1 / 592 (0.17%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    0 / 5
    4 / 13
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial tachycardia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrioventricular block complete
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bradycardia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bundle branch block left
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    cardiac failure
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    1 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 2
    cardiac failure acute
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac failure chronic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    3 / 297 (1.01%)
    4 / 2579 (0.16%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    chronic left ventricular failure
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery occlusion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery stenosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mitral valve disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mitral valve incompetence
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 6
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial ischaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    palpitations
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pericarditis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    right ventricular failure
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    sinus node dysfunction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sinus tachycardia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    stress cardiomyopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    supraventricular tachycardia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ventricular arrhythmia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ventricular fibrillation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ventricular tachycardia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    amyotrophic lateral sclerosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    autonomic neuropathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    basal ganglia haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    central nervous system vasculitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebellar infarction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebellar stroke
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral artery stenosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral artery thrombosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    cerebral infarction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral microhaemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral thrombosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral venous thrombosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebrospinal fistula
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebrospinal fluid leakage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebrovascular disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cervical cord compression
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cervical radiculopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dementia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    depressed level of consciousness
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dizziness
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    embolic stroke
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    epilepsy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhage intracranial
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhagic stroke
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    5 / 2579 (0.19%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    headache
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hemiparesis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intercostal neuralgia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intracranial aneurysm
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ischaemic cerebral infarction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    5 / 297 (1.68%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    leukoencephalopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    loss of consciousness
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metabolic encephalopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    migraine
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myelopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    neuralgia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    neuropathy peripheral
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral sensorimotor neuropathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    post herpetic neuralgia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    presyncope
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    radiculopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sciatica
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    seizure
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sensory disturbance
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    9 / 2579 (0.35%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 10
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thalamus haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    3 / 2579 (0.12%)
    2 / 592 (0.34%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 4
    0 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coagulopathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    leukocytosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lymphopenia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    normochromic normocytic anaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    normocytic anaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancytopenia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thrombocytosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    conductive deafness
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    deafness unilateral
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meniere's disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sudden hearing loss
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vertigo
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vertigo positional
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    6 / 2579 (0.23%)
    3 / 592 (0.51%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 13
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cataract subcapsular
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    corneal perforation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dry age-related macular degeneration
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    glaucoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    keratitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    macular rupture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ocular hypertension
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    retinal detachment
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rhegmatogenous retinal detachment
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    abdominal pain upper
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    abdominal wall haematoma
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    anal fistula
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colitis ischaemic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colitis ulcerative
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dental cyst
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diverticular perforation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diverticulum
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diverticulum intestinal
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    duodenal ulcer haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    duodenitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dysphagia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    enterocolitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastric ulcer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastric ulcer haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastric ulcer perforation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastritis erosive
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhoids
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hiatus hernia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ileus
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    inguinal hernia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal perforation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    irritable bowel syndrome
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    obstructive pancreatitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oesophageal stenosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    6 / 2579 (0.23%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 7
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    parotid gland enlargement
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rectal haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rectal polyp
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    reflux gastritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    umbilical hernia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    volvulus
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    actinic keratosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    angioedema
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diabetic ulcer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    eczema asteatotic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    granuloma skin
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    skin ulcer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    skin necrosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bladder prolapse
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    calculus bladder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    calculus urinary
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chronic kidney disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    glomerulonephritis membranous
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hydronephrosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    iga nephropathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    5 / 2579 (0.19%)
    3 / 592 (0.51%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oliguria
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    proteinuria
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal colic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal cyst
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal injury
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal vein thrombosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    stress urinary incontinence
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tubulointerstitial nephritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ureterolithiasis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    6 / 2579 (0.23%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract inflammation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    adrenal suppression
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    goitre
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyperparathyroidism
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    acquired claw toe
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    arthralgia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    arthritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    back pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    5 / 2579 (0.19%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cervical spinal stenosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chondrocalcinosis pyrophosphate
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diastasis recti abdominis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    foot deformity
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    4 / 2579 (0.16%)
    3 / 592 (0.51%)
    6 / 594 (1.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fracture delayed union
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haematoma muscle
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc compression
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc degeneration
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc disorder
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    7 / 2579 (0.27%)
    5 / 592 (0.84%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint destruction
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lumbar spinal stenosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    4 / 2579 (0.16%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mixed connective tissue disease
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    muscular weakness
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    8 / 297 (2.69%)
    42 / 2579 (1.63%)
    6 / 592 (1.01%)
    5 / 594 (0.84%)
         occurrences causally related to treatment / all
    0 / 13
    4 / 56
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteochondrosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteonecrosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 2579 (0.08%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoporosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoporotic fracture
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pain in extremity
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rhabdomyolysis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rheumatoid arthritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    4 / 297 (1.35%)
    16 / 2579 (0.62%)
    0 / 592 (0.00%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 18
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rheumatoid nodule
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    scoliosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal instability
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal stenosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spondylolisthesis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spondyloarthropathy
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    synovial cyst
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    synovitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tendonitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tenosynovitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    abdominal infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    abdominal wall abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    abscess intestinal
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    abscess limb
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    anal abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    appendicitis perforated
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    appendicitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    4 / 594 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    arthritis bacterial
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    arthritis infective
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atypical pneumonia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bacteraemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bacterial infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bone tuberculosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    breast abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    5 / 2579 (0.19%)
    2 / 592 (0.34%)
    5 / 594 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 6
    3 / 3
    6 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bronchitis viral
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bursitis infective
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bursitis infective staphylococcal
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    covid-19
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    covid-19 pneumonia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    3 / 297 (1.01%)
    12 / 2579 (0.47%)
    0 / 592 (0.00%)
    4 / 594 (0.67%)
         occurrences causally related to treatment / all
    2 / 3
    7 / 14
    0 / 0
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholecystitis infective
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    chronic sinusitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chronic tonsillitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronavirus infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    cystitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cytomegalovirus hepatitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cytomegalovirus infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dengue fever
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    device related sepsis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    disseminated tuberculosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    3 / 297 (1.01%)
    4 / 2579 (0.16%)
    3 / 592 (0.51%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 4
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    empyema
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    encephalitis viral
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endocarditis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endocarditis bacterial
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    enteritis infectious
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    enterobacter pneumonia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    enterocolitis infectious
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    escherichia sepsis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    extrapulmonary tuberculosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fascial infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gangrene
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    7 / 2579 (0.27%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 7
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis norovirus
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis salmonella
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis viral
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    groin abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    h1n1 influenza
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haematoma infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    helicobacter gastritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hepatitis e
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    herpes zoster infection neurological
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    herpes zoster
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    5 / 297 (1.68%)
    15 / 2579 (0.58%)
    2 / 592 (0.34%)
    5 / 594 (0.84%)
         occurrences causally related to treatment / all
    4 / 5
    20 / 20
    3 / 3
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    herpes zoster meningitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    histoplasmosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    implant site infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    incision site cellulitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    infected dermal cyst
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    infected skin ulcer
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    infectious pleural effusion
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    infective aneurysm
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 4
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral discitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    klebsiella bacteraemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    localised infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lymph node tuberculosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meningoencephalitis bacterial
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    necrotising fasciitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ophthalmic herpes zoster
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oral fungal infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    orchitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [36]
    0 / 66 (0.00%)
    1 / 548 (0.18%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteomyelitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    otitis media
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    paracoccidioides infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    paronychia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pelvic abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    perirectal abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peritonitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    plasmodium falciparum infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    plasmodium vivax infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    15 / 297 (5.05%)
    34 / 2579 (1.32%)
    10 / 592 (1.69%)
    12 / 594 (2.02%)
         occurrences causally related to treatment / all
    11 / 17
    20 / 36
    11 / 14
    8 / 15
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 2
    pneumonia bacterial
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia cryptococcal
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia influenzal
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia viral
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia legionella
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    post procedural infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    postoperative abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    postoperative wound infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pseudomonal bacteraemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    psoas abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary tuberculosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    4 / 592 (0.68%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis acute
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    respiratory syncytial virus infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    salpingitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [37]
    0 / 231 (0.00%)
    1 / 2031 (0.05%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    3 / 297 (1.01%)
    10 / 2579 (0.39%)
    1 / 592 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    2 / 4
    5 / 10
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
    0 / 0
    septic shock
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
    0 / 0
    sinusitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sinusitis bacterial
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    skin infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    staphylococcal bacteraemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    staphylococcal sepsis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    subcutaneous abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    systemic infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    testicular abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [38]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 152 (0.66%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thrombophlebitis septic
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tooth abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tuberculosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    4 / 297 (1.35%)
    12 / 2579 (0.47%)
    0 / 592 (0.00%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    3 / 7
    7 / 12
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection bacterial
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection enterococcal
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urosepsis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 6
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
    varicella
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    varicella zoster virus infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    viral infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vulvitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed [39]
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 440 (0.23%)
    0 / 448 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound abscess
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound sepsis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 2579 (0.16%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diabetes mellitus
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    1 / 592 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diabetic ketoacidosis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 2579 (0.08%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diabetic metabolic decompensation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    electrolyte imbalance
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyperglycaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyperkalaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    0 / 2579 (0.00%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypokalaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    3 / 2579 (0.12%)
    1 / 592 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    obesity
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    2 / 297 (0.67%)
    0 / 2579 (0.00%)
    2 / 592 (0.34%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 2579 (0.04%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 2 mg Baricitinib 4 mg Baricitinib 2 mg Baricitinib Step-Down 4 mg Baricitinib Step-Down
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    234 / 297 (78.79%)
    1532 / 2579 (59.40%)
    270 / 592 (45.61%)
    315 / 594 (53.03%)
    Investigations
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    22 / 297 (7.41%)
    176 / 2579 (6.82%)
    20 / 592 (3.38%)
    33 / 594 (5.56%)
         occurrences all number
    26
    229
    26
    44
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    33 / 297 (11.11%)
    196 / 2579 (7.60%)
    38 / 592 (6.42%)
    46 / 594 (7.74%)
         occurrences all number
    36
    218
    38
    47
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    19 / 297 (6.40%)
    90 / 2579 (3.49%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    21
    106
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    18 / 297 (6.06%)
    126 / 2579 (4.89%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    21
    156
    0
    0
    General disorders and administration site conditions
    pyrexia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    16 / 297 (5.39%)
    56 / 2579 (2.17%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    17
    62
    0
    0
    Gastrointestinal disorders
    constipation
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    20 / 297 (6.73%)
    72 / 2579 (2.79%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    24
    79
    0
    0
    diarrhoea
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    18 / 297 (6.06%)
    87 / 2579 (3.37%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    25
    107
    0
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    28 / 297 (9.43%)
    105 / 2579 (4.07%)
    35 / 592 (5.91%)
    25 / 594 (4.21%)
         occurrences all number
    46
    134
    37
    32
    Psychiatric disorders
    insomnia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    16 / 297 (5.39%)
    47 / 2579 (1.82%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    16
    50
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    43 / 297 (14.48%)
    155 / 2579 (6.01%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    58
    229
    0
    0
    back pain
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    42 / 297 (14.14%)
    162 / 2579 (6.28%)
    35 / 592 (5.91%)
    36 / 594 (6.06%)
         occurrences all number
    55
    181
    41
    43
    pain in extremity
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    16 / 297 (5.39%)
    53 / 2579 (2.06%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    25
    63
    0
    0
    rheumatoid arthritis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    27 / 297 (9.09%)
    141 / 2579 (5.47%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    38
    250
    0
    0
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    48 / 297 (16.16%)
    291 / 2579 (11.28%)
    44 / 592 (7.43%)
    65 / 594 (10.94%)
         occurrences all number
    65
    431
    61
    91
    herpes zoster
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    30 / 297 (10.10%)
    160 / 2579 (6.20%)
    39 / 592 (6.59%)
    53 / 594 (8.92%)
         occurrences all number
    32
    167
    42
    57
    influenza
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    15 / 297 (5.05%)
    147 / 2579 (5.70%)
    30 / 592 (5.07%)
    56 / 594 (9.43%)
         occurrences all number
    16
    176
    35
    64
    nasopharyngitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    42 / 297 (14.14%)
    291 / 2579 (11.28%)
    54 / 592 (9.12%)
    58 / 594 (9.76%)
         occurrences all number
    95
    488
    109
    101
    pharyngitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    19 / 297 (6.40%)
    119 / 2579 (4.61%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    30
    181
    0
    0
    pneumonia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    17 / 297 (5.72%)
    66 / 2579 (2.56%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    19
    71
    0
    0
    sinusitis
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    23 / 297 (7.74%)
    100 / 2579 (3.88%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    31
    121
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    58 / 297 (19.53%)
    281 / 2579 (10.90%)
    46 / 592 (7.77%)
    51 / 594 (8.59%)
         occurrences all number
    106
    454
    54
    63
    urinary tract infection
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    53 / 297 (17.85%)
    241 / 2579 (9.34%)
    34 / 592 (5.74%)
    52 / 594 (8.75%)
         occurrences all number
    84
    336
    48
    72
    Metabolism and nutrition disorders
    hypercholesterolaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    16 / 297 (5.39%)
    142 / 2579 (5.51%)
    18 / 592 (3.04%)
    32 / 594 (5.39%)
         occurrences all number
    19
    162
    18
    32
    hyperlipidaemia
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    18 / 297 (6.06%)
    133 / 2579 (5.16%)
    0 / 592 (0.00%)
    0 / 594 (0.00%)
         occurrences all number
    20
    157
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Mar 2014
    Amendment (d): Allowed additional enrollment of participants and extend duration of study.
    30 Oct 2014
    Amendment (e): Allowed for additional 24 months of treatment duration.
    30 Jan 2017
    Amendment (f): Allowed for additional 12 months of treatment duration.
    11 Dec 2017
    Amendment (g): Allowed for an additional 24 months of treatment duration.

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

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

    European Medicines Agency © 1995-Sat Apr 20 00:13:56 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA